Cancer Consult - Cleveland Clinic · (ASTRO) meeting in Chicago in November provides a glimpse into the breakthrough research in which we are involved. We were very well-represented

Ta u s s i g C a n c e r I n s t i t u t e | A S T R O 2 0 0 9 E d i t i o n

Cancer ConsultHigHligHts from the 2009

American Society for Radiation Oncology Meeting

Dear Colleagues and Friends:

The Department of Radiation Oncology is pleased to be highlighted in

this issue of Cancer Consult. As you will see in the following pages,

2009 was a very productive year in the department. Our participation

in the 51st annual American Society for Radiation Oncology

(ASTRO) meeting in Chicago in November provides a glimpse into

the breakthrough research in which we are involved. We were very

well-represented at this meeting, with more than 20 oral and poster

presentations. In addition, Ping Xia, PhD, our new head of medical

physics, led an education session on the transition from 3D IMRT to

4D IMRT. And for the first time, each of our residents who attended

ASTRO had a poster or oral presentation, which speaks very highly of

the dedication and caliber of our residents.

This newsletter also highlights our extensive database of more than

11,000 prostate cancer patients who have undergone surgery, external

beam radiation therapy or brachytherapy at Cleveland Clinic. This

database, which is one of the largest in the world, is meticulously

maintained by Chandana Reddy, our biostatistician, and has been the

source for more than 100 papers.

In October, we were fortunate to welcome executives from major

radiation oncology corporations to our campus as part of the Medical

Innovations Summit on “Improving the Prognosis: Cancer Cures through

Innovation.” It was a chance for experts from throughout the world to

wrestle with the challenges in developing new approaches to cancer

care and to discuss future trends and opportunities. This newsletter

includes an overview of the summit on pages 6-7.

We hope you find this edition of Cancer Consult valuable, as it high-

lights new directions in our field and some of our newer programs

within the Taussig Cancer Institute. Our most important mission is to

deliver outstanding care to our patients and ultimately to win the war

on cancer. On behalf of the department, I would like to thank all of you

for your ongoing support and I look forward to continued collaboration

with you. Please feel free to contact me with any questions, concerns

or suggestions on how we can improve our service to you and your

patients, at [email protected].

Sincerely,

John Suh, MD

Chairman, Department of Radiation Oncology

Cleveland Clnic to Launch Pilot

Study to Compare Calypso with other

Therapy Modalities...1

Resident Wins 2009 American

Medical Association Award...4

Trial Paves Way for Multicenter

Study of External Beam

Radioimmunotherapy in Low-Grade

Lymphoma Management...5

Summit Showcases Improving

Prognosis in C2ancer Through

Innovation ...6

Prostate Cancer Database Is Valuable

Research Tool…8

Changing Patient Population Prompts

Study of Androgen Deprivation

Therapy in Prostate Cancer…9

Cleveland Clinic Leads RTOG

Randomized Study for Patients

with Inoperable Early-Stage Lung

Cancer…10

Radiation Oncology Welcomes New

Head of Medical Physics…13

CLINICAL TRIALS…14

PUBLICATIONS….16

Tumor motion during radiation therapy has always presented difficult

challenges for radiation oncologists. New medical technology, however,

is helping radiation oncologists address this challenge.

T E C h n O l O g y A D v A n C E S

Cleveland Clinic to Launch Pilot Study to Compare Calypso with other Therapy Modalities

In 2005, Cleveland Clinic was one of five medical

centers in the nation that participated in a prostate

cancer research study involving unique and in-

novative technology, the Calypso 4D Localization

System. Developed by Calypso Medical Technolo-

gies Inc., the external beam radiation system pre-

cisely tracks the movement of the prostate during

therapy, optimizing radiation targeting and mini-

mizing its side effects. The purpose of the clinical

study was to evaluate a nonionizing electromag-

netic method to align the prostate treatment site

for therapy and to monitor its position throughout

therapy delivery.

“During the preliminary research phase of the

Calypso System, we demonstrated that there is

fairly substantial motion of the prostate while

the patient is lying on the treatment table,” says

Rahul Tendulkar, MD, Cleveland Clinic radiation

oncologist. “One of the benefits of the Calypso

System is its ability to track the position of the

prostate in real time by emitting radio-frequency

signals from miniature Beacon wireless electro-

magnetic transponders about 8 mm in length.

The transponders are implanted transrectally

into the prostate in an outpatient procedure.

The transponders transmit the information at a

frequency of every one-tenth of a second, which

enables the real time information.”

The clinical study compared the electromagnetic

positioning to setup using skin marks and to

stereoscopic X-ray localization of the transpon-

ders. Study results published in the International

Journal of Radiation Oncology, Biology and Physics in

2007 determined that the difference between skin

marks versus the Calypso System alignment was

found to be > 5 mm in vector length in more than

T E C h n O l O gy A D vA n C E S

( c o n t i n u e d )

CLeveLAnd CLiniC | TAuSSig CAnCeR inSTiTuTe | CAnCeR COnSuLT

75 percent of fractions. Comparisons between

the Calypso System and X-ray localization showed

good agreement.

Qualitatively, the continuous motion was un-

predictable and varied from persistent drift to

transient rapid movements. Displacement > 3 mm

and > 5 mm for cumulative durations of at least 30

seconds were observed during 41 percent and 15

percent of sessions, respectively.

For individual patients, the number of fractions

with displacement >3 mm ranged from 3 percent

to 87 percent, whereas the number of fractions

with displacements >5 mm ranged from 0 percent

to 56 percent. What’s more, the Calypso System’s

transponders were typically stable four days post

implant (all by 14 days) and <1 mm standard devia-

tion for inter-transponder distances over time. All

of the transponders remained functional through-

out therapy.

“The Calypso System is a clinically efficient and

objective localization method for positioning

prostate patients undergoing radiotherapy,” the

study concluded. “Initial treatment setup can

be performed rapidly, accurately and objectively

before radiation delivery. The extent and frequency

of prostate motion during radiotherapy delivery

can be easily monitored and used for motion

management.”

“The vast majority of prostate cancer patients are

candidates for treatment with the Calypso System,”

says Dr. Tendulkar. “However, there are a few

contraindications such as, patients with implanted

devices including neurostimulators and cardiac

pacemakers, because these devices might interfere

with the transponder signals. Patients who have

had hip replacement surgery or who are obese are

not candidates for this treatment.”

In 2010, Dr. Tendulkar will be launching a pilot

research study that will compare the Calypso

System with other treatment modalities such as

cone beam CT scan-based image guidance and

ultrasound-based image guidance technology.

Modern external beam radiation therapy utilizes

CT scans and sophisticated software to create a

three-dimensional computer model of the area

being treated. This allows clinicians to more

precisely target treatments at the tumor and spare

surrounding healthy tissue or organs. The inten-

sity modulated radiotherapy is combined with

an image guidance system for localization of the

prostate. This combination provides the delivery of

a focused and individualized dose of radiation to a

small area within the pelvis.

“In our small pilot study, we want to make a

head-to-head comparison of each image-guided

technology to help us define the accuracy of each

method in delivering radiation therapy to treat

prostate cancer patients,” says Dr. Tendulkar.

“Initially, we expect to recruit three to five patients.

Depending on the preliminary data we collect

from that small group of patients, we may be able

to increase the patient pool to 15 or 20.” The pilot

study is being funded by a $50,000 grant from the

Scott Hamilton CARES Foundation.

Dr. Tendulkar notes there are research studies un-

der way at other academic and medical institutions

that are exploring whether the Calypso System can

be utilized to treat other cancers of the body, such

as those in the pancreas, lung, and head and neck.

2 | 3 | clevelandclinic.org/cancerconsult

For more information about the Calypso System, please visit www.clevelandclinic.org/calypso, or to refer a patient, call 216.445.8290.

CAnCeR COnSuLT ASTRO 2009 ediTiOn

Cleveland Clinic Radiation Oncology

resident Michael Burdick, MD, recently

earned first place in the Clinical Medicine

category at the American Medical Associa-

tion-Resident and Fellow Section Research

Symposium for his poster presentation:

“External Beam Radiotherapy Followed by

90Y Ibritumomab Tiuxetan in Relapsed

Bulky Follicular Lymphoma.” Dr. Burdick

presented the poster at the American

Society for Radiation Oncology annual

meeting. His paper on the project has been

accepted for publication in the Interna

tional Journal of Radiation Oncology, Biology

and Physics.

Dr. Burdick graduated from the University

of Virginia and earned his medical degree

from Virginia Commonwealth University.

Before coming to Cleveland Clinic, he

completed an internship at the University

of Washington. Dr. Burdick’s training also

involved a year at the National Institutes of

Health in brain tumor research, spurring

his interest in cancer.

“I wanted to pursue oncology, but I

vacillated between medical and radiation

oncology,” he says. “Radiation won

because of the cool technologies.”

Dr. Burdick says the chance to work with

a world-renowned staff drew him to

Cleveland Clinic. “I knew I would see every

Resident Wins 2009 American Medical Association Award

Top: Positron emission tomography/computed tomography (PET/CT) scan with 2-deoxy-2-[18F] fluoro-D-glucose (FDg) depicts a 9 cm x 5 cm para-aortic mass in a 79-year-old man with follicular lymphoma.

Bottom: Four months after treatment with external beam radiotherapy and 90y ibritumomab tiuxetan, FDg PET/CT revealed normalization of FDg uptake and near-complete resolution of the mass.

type of tumor, as well as every technique

used in radiation oncology at Cleveland

Clinic,” he says. “The residency program

has exceeded my expectations. I’ve gotten

excellent preparation for my boards,

but I’m also prepared to become a well-

rounded physician.”

CLeveLAnd CLiniC | TAuSSig CAnCeR inSTiTuTe | CAnCeR COnSuLT

While immunotherapy has improved treatment

since its approval in the late ‘90s, Cleveland Clinic

radiation oncologist Roger Macklis, MD, says that

sites harboring bulky disease are associated with

a particularly poor likelihood of responding and

shorter durability of response.

Dr. Macklis and his colleagues recently reported

encouraging results of a Phase II study in which

external beam radiotherapy (EBRT) was combined

with yttrium-90 ibritumomab tiuxetan (90Y-IT)

in 11 patients with relapsed or refractory bulky

follicular lymphoma.

Cleveland Clinic resident Michael Burdick, MD,

presented a poster on the study during the 2009

American Society for Radiation Oncology annual

meeting (see related story).

For the purpose of the study, bulky disease was

defined as >5 cm. Using computed tomography

(CT)-based planning, bulky disease sites were

contoured as the gross tumor volume with a

planning margin of 1 cm to 2 cm added, depending

on anatomical location. EBRT was delivered as

2400 cGy in 8 fractions.

Once the patient achieved complete blood count

recovery, 90Y-IT was administered at a dose of

0.3 or 0.4 mCi/kg, depending on platelet counts.

Response was measured by positron emission

tomography/CT and/or CT three to four months

after administration.

“In general, this combined approach appeared

to work as we hypothesized,” says Dr. Macklis.

“In contrast to prior patterns of failure analysis

data in this patient population, a brief course of

external beam radiotherapy prevented relapse in

sites of bulky disease.” Both in-field control and

Trial Paves Way for Multicenter Study of external Beam and Radioimmunotherapy in Low-grade Lymphoma Management

progression-free survival compared favorably

to historical data. The complete and overall

responses to combined therapy as measured

three to four months after 90Y-IT were 64 percent.

Median progression-free survival was 17.5 months.

“While the trial was not statistically significant

due to its nonrandomized design and small size,

we hope our results will create a paradigm for the

future,” says Dr. Macklis. Plans are currently being

considered for an industry-funded multicenter

trial expanding on this experience.

To learn more about this trial or to refer a patient to Dr. Macklis, call 216.444.5576 or email [email protected].

Between 20,000 and 25,000 patients in the United States present with indolent B-cell

non-Hodgkin lymphoma every year, representing a diverse epidemiologic cohort.


Taussig Cancer Institute Chairman Derek Ragha-

van, MD, PhD, chaired a roundtable discussion on

the “Grand Challenges in Contemporary Cancer

Treatment and Biology.” Tom Miller, CEO of work-

flow solutions at Siemens; Sir Bruce Ponder, MD,

director of the Cancer Research UK Cambridge

Research Institute; and William Hait, MD, senior

vice president and worldwide leader of hematolo-

gy and oncology at Johnson & Johnson, concluded

that while developing cancer treatments is time-

consuming and costly, information technologies

will be important in pairing the right patients with

the right treatments.

Partnering with others can help speed the develop-

ment process, Miller said. But accounting is the

greatest impediment to progress. “We don’t know

the return on the investment we do,” he said.

John Suh, MD, chairman of the Department

of Radiation Oncology in the Taussig Cancer

Institute, moderated a panel on the “Revolution in

Radiotherapy Technology,” with Jean Marc Andral,

president of Advanced Radiotherapy, IBA; Shawn

Guse, vice president of International Operations,

TomoTherapy and CEO of Compact Particle

Acceleration Corporation; Tomas Puusepp, CEO

at Elekta; Eric Lindquist, senior vice president of

Accuray; and Dow Wilson, president of Oncology

Systems, Varian. The group provided a firsthand

analysis of new directions and challenges for

innovators in radiotherapy.

“Radiation oncology is at the forefront in terms

of using evidence-based medicine to differenti-

ate various approaches to cancer,” Dr. Suh said.

“Technological advances and a better under-

standing of how tumors respond to treatment

have meant shorter and more precise radiation

treatment options. The question has become: At

what cost?”

summit showcases improving Prognosis in Cancer through innovation

In October 2009, Cleveland Clinic hosted a Medical Innovations Summit

that brought more than 900 prominent physicians, senior executives from

pharmaceutical and medical device companies, entrepreneurs, investors and

others together for an in-depth analysis of innovation in the field of cancer.

2009

Cleveland Clinic president and CEO Toby Cosgrove, MD, opened the summit with an address on

healthcare reform, saying that in the United States, we are debating health insurance reform instead of

health care reform. Rather than demand higher reimbursements for care, doctors and hospitals ought

to demand greater efficiency in delivering care, he said. In addressing innovation in healthcare, Dr.

Cosgrove said, “Some people see devices and drugs as a problem. We see them as part of the solution.”

Device manufacturers agreed that the economic

challenges of developing and testing technology

are huge. “One successful cancer drug would

produce more revenue than all of the companies

on this stage,” said Mr. Guse.

Panel members returned to a familiar summit

theme, stressing the importance of informatics to

improve access to patient data and increase out-

comes research. “Radiation plays a role in nearly

two-thirds of all cancer patients, but we are losing

market share in some areas to other care modali-

ties,” said Mr. Wilson. “We have great tools, but

we have to prove their worth. We have to make a

better case about the outcomes of radiation treat-

ments. Comparative effectiveness will become

more and more important.”

In his keynote address, Sam Palmisano, IBM

chairman, president and CEO, revealed that the

time has come for a smarter healthcare system.

“The single issue that is most critical to the future

of healthcare in this country—and the world—is

the need for a true healthcare system,” he said.

“And I believe we have a better chance now than

ever before to build it.”

Mr. Palmisano said that there is a broad

consensus—forged, in many respects, by the

example of such institutions as Cleveland

Clinic—that American healthcare must become

patient-centric. But it must also be value-focused,

evidence-based, accountable and sustainable.

Clearly, a smarter healthcare system, optimized

around the patient, would increase efficiency,

reduce errors, achieve better quality outcomes

and save lives. “It could embed best practices and

medical knowledge—as well as real-time patient

monitoring—into clinical and business workflows,

for error-free delivery of care,” said Mr. Palmi-

sano. “And that alone is ample justification for the

investment.”

The summit concluded with the unveiling of the

“Top 10” Medical Innovations for 2010, emerging

technologies that will shape healthcare this year.

The list of breakthrough devices and therapies was

selected by a panel of Cleveland Clinic physicians

and scientists. This year’s No. 1 innovation

was Bone Conduction of Sound for Single-

Sided Deafness: a new nonsurgical, removable

hearing and communication device designed to

imperceptibly transmit sound via the teeth to help

people with single-sided deafness.

For a complete list of the “Top Ten” and details

of next year’s summit, “Obesity, Diabetes & the

Metabolic Crisis,” visit clevelandclinic.org/

innovations.


“Radiation oncology is at the fore-

front in terms of using evidence-based

medicine to differentiate various

approaches to cancer.”

The two-day event highlighted the need for partnerships

among researchers and developers, since no one institu-

tion or company has the financial or intellectual assets

to go this route alone.


Clinical databases are becoming more prevalent at

institutions that treat large populations of prostate

cancer patients. The Cleveland Clinic database is

unique in its breadth and depth of information

and in its multidisciplinary orientation, notes

biostatistician Chandana Reddy, MS.

“We are the only institution that integrates radia-

tion and surgery patients in a single database,” she

says. “That structure was decided at the outset as

the most accurate way to track and compare out-

comes across different patient populations.”

Data on all patients treated by prostatectomy,

external beam radiation or brachytherapy are

entered from multiple sources. “To create a

complete profile for each patient, the database

includes patient demographics, family history to

second-degree relatives and all pre- and post-

treatment clinical data,” Reddy explains. Each

patient’s pre- and post-treatment PSA values,

biopsy Gleason score and tumor stage are

recorded, along with the treatment modality.

For patients who undergo external beam radiation

or brachytherapy, the database captures dosim-

etry, radiation dose and the number of fractions

or the number of brachytherapy seeds. Following

completion of treatment, all follow-up PSA results

are recorded to track patient outcomes in terms

of disease-free survival, biochemical recurrence,

cancer recurrence and all-cause mortality.

At the 2009 ASTRO meeting, the Cleveland Clinic

database was the foundation for three oral pre-

sentations and four poster presentations, includ-

ing an oral presentation by Andrew Vassil, MD,

(see related story). Other ASTRO presentations

that utilized the database featured an analysis of

Prostate Cancer database is valuable Research Tool

Cleveland Clinic Taussig Cancer Institute is home to one of the most sophisticated prostate cancer

databases in the world. Containing comprehensive baseline, treatment and follow-up data on more than

11,000 patients treated since 1986, the database is a powerful resource for prostate cancer research.

treatment effectiveness in prostate cancer patients

younger than 55 and an exploration of factors that

are predictive for early mortality in men treated for

localized prostate cancer.

“These studies demonstrate the power of our

database,” Reddy says. “Because it contains such

in-depth data on such a large number of patients,

researchers have the luxury of selecting exactly the

patient population they want to study.”

Another advantage for researchers is that individu-

al patient records in the database are indexed by a

unique patient number. This allows easy retrieval

and cross-referencing with stored prostate biopsy

tissue samples. “The tissue repository enhances the

utility of the prostate cancer database by providing

DNA for molecular studies,” Reddy explains.

Beyond pure research applications, the database

also is used for treatment planning and quality

monitoring, she adds. “Our core group of prostate

cancer specialists reviews the trends in patient treat-

ment and outcomes as a tool for improving quality

of care and pursuing new avenues of research. One

of the results from these review meetings was our

group’s research in the area of prostate cancer

specific mortality. We were the first institution to

begin studying this endpoint across all treatment

modalities, and we are now seeing other institu-

tions assess their patients for this endpoint.”

Historically, more than 100 papers have been

published based on research using the database. In

addition to the presentations at ASTRO in 2009, the

database was used for two oral presentations and

two posters presented at the American Brachyther-

apy Society annual meeting and three posters pre-

sented at the Genitourinary Cancers Symposium.

Andrew Vassil, MD, resident and investigator in

the Department of Radiation Oncology, presented

a study during the 2009 ASTRO annual meeting

assessing the duration of androgen deprivation

therapy used in the management of patients with

high-risk prostate cancer undergoing curative

external beam radiation therapy.

Dr. Vassil examined earlier studies and compared

them to more recent Cleveland Clinic outcomes.

Earlier research showed that for men with locally

advanced prostate cancer, the addition of long-

term (> 2 years) androgen deprivation (AD) in

addition to definitive external beam radiotherapy

resulted in improved local and distant control;

disease-specific survival; and, in some cases, over-

all survival. Other studies have shown that higher

doses of radiation therapy are safe, and may be

more effective for patients with localized prostate

cancer. AD therapy is associated with multiple side

effects, including an increased risk of heart attack.

Recently, with the advent of PSA screening, a stage

migration has occurred, resulting in diagnosis at

an earlier stage, younger age, lower PSA, and with

a less aggressive cancer. “Because of these prostate

cancer population changes, patients treated on pri-

Above: high radiation dose is safely distributed to the prostate with relative sparing of normal structures such as the bladder and rectum.

Right: Multiple radiation fields may be shaped, modulated and combined to intersect at the tumor site and avoid high radiation doses to normal organs.


Changing Patient Population Prompts Study of Androgen deprivation Therapy in Prostate Cancer

or trials are not representative of current patients,”

says Dr. Vassil. “In addition, radiation techniques

and doses used in the past are now considered

suboptimal. Despite these significant changes, it

remains common practice to offer long-term AD to

patients with localized disease.”

Dr. Vassil and his colleagues reviewed Cleveland

Clinic institutional outcomes, stratified by dura-

tion of AD, to estimate its effect on prostate cancer

control and survival. The study included 553

patients with high-risk prostate cancer treated at

Cleveland Clinic.

All these patients received high-dose radiation

therapy using modern delivery techniques. Treat-

ment with more than six months of AD did not

appeared to improve PSA control or disease recur-

rence rates. These patients also had worse overall

survival and appeared to develop cancer resistant

to the effects of androgen suppression sooner (also

known as androgen-independent prostate cancer).

“Long-term AD may cause weight gain, hot flashes,

mood changes, bone mineral density loss and

heart disease for no therapeutic gain,” concludes

Dr. Vassil. “It is possible that modern radiation

techniques delivering high radiation doses

may overcome the need for long-term AD, thus

preserving patients’ quality of life after receiving

curative treatment.”


SBRT is a novel form of radiation delivery that is

becoming increasingly utilized to manage NSCLC

in patients for whom surgery is contraindicated,

because it delivers highly precise, very high-dose

radiotherapy (RT) in very few fractions. SBRT

requires very accurate tumor delineation and

methods by which tumor motion due to breathing

is accounted for during the delivery process.

SBRT has been shown to provide remarkably high

rates of local control, comparable to those seen

with surgery, but with little severe toxicity in what

is otherwise a fragile patient population. The

optimal treatment schedule in the setting of SBRT

is currently an active area of investigation. When

first being explored a decade ago, up to 10 treat-

ments might have made up a course of SBRT. The

primary objective of the RTOG 0915 randomized

Phase II study is to determine the one-year rate

of > grade 3 adverse events related to treatment

with single fraction versus 4 fractions of SBRT in

medically inoperable patients with stage I NSCLC.

Sponsors of the study are the Radiation Therapy

Oncology Group (RTOG) and the National Cancer

Institute.

“What is interesting in the RTOG 0915 study is that

we think the delivery of a single fraction or multiple

fractions will be essentially equivalent in eradicat-

ing the cancer,” says Dr. Videtic. “Now we’re inter-

ested in which treatment will be associated with the

lowest rate of side effects for these fragile patients,

even though the risk of developing complications

may be low to begin with. As we now are seeing

these patients many months and even years after

their cancer is eradicated, we are finding that for

tumors close to the rib cage, there may be a higher

risk for patients to develop delayed fractures.”

Lung cancer is the leading cause of cancer mortality

in the United States. Eighty percent of lung cancers

are NSCLC, and approximately 15 to 20 percent of

these patients present with early localized NSCLC.

Patients who undergo surgical treatments can

expect a five-year survival rate of 50 to 70 percent,

depending on the initial size of their tumors.

However, a significant number of NSCLC patients

do not qualify for the surgical treatment because of

co-morbidities including advanced heart disease,

emphysema, bronchitis or other complications

such as tumor location.

Medically inoperable early-stage NSCLC patients

have been historically treated with conventional ex-

ternal beam RT. Unfortunately, these RT treatment

results invariably proved inferior to surgical results,

likely due to the interaction between an inability to

control the cancer with modest RT doses and the

underlying medical conditions of the patients.

For example, one study involved 141 patients with

stage I NSCLC who were treated with RT using

modern techniques and staging. The median RT

dose delivered was 64 Gy (range: 48 Gy to 80 Gy).

The overall survival rate at one and five years was

39 percent and 13 percent, respectively, while the

progression-free survival was 48 percent and 28

percent at two and five years, respectively. Forty-

nine percent of patients had local failure as part

of their relapse pattern. In fact, other studies have

reported local recurrence to be the most common

cause of failure with standard RT.

SBRT was pioneered by Swedish and Japanese

medical researchers more than 10 years ago. In

the United States, Indiana University has been a

leader in SBRT research, conducting foundational

n E w R E S E A R C h :

Cleveland Clinic Leads RTOg Randomized Study for Patients With inoperable early-Stage Lung Cancer

Cleveland Clinic Radiation Oncologist Gregory Videtic, MD, is the principal investigator for a new

randomized Phase II study comparing stereotactic body radiation therapy (SBRT) schedules for

medically inoperable patients with stage I peripheral non-small cell lung cancer (NSCLC).

To refer a patient, please call Dr. Videtic at 216.444.9797.

research trials about six years ago. After promising

Phase I study results, a Phase II prospective study

was carried out, involving 70 patients who received

doses of 60 Gy to 66 Gy in three fractions during

one to two weeks. With a median follow-up of 17.5

months, actuarial local control at two years was 95

percent. However, the study also found that Grade

3 to 5 toxicity occurred in 14 patients, which on

analysis proved to be associated with tumor loca-

tion, i.e., lesions in close proximity to the tracheo-

bronchial tree and mediastinum. Currently, RTOG

is conducting a study on the maximally tolerated

SBRT dose for this class of tumors (RTOG 0813). All

ongoing studies in SBRT now make the distinction

between such tumors, termed central, and all oth-

ers, termed peripheral.

Since the efficacy and safety of SBRT for peripheral

tumors has become established, medical oncolo-

gists at Cleveland Clinic have collaborated with

radiation oncologists in offering SBRT treatments

to stage I NSCLC patients.

“It’s very gratifying that we can offer not only an

effective but safe treatment for NSCLC patients,

because before SBRT their options were extremely

limited,” says Dr. Videtic. “This represents a huge

shift in practice.”

Some of the secondary objectives of the RTOG 0915

study will include estimating the one-year local

control rate in patients and estimating the one-

year overall survival and disease-free survival rate.

Patients will be randomly assigned to two groups.

One group will receive a single fraction once, and

the second group will receive a single fraction once

a day for four days.


For more information about the RTOG 0915 study, visit http://www.clinicaltrials.gov/ct2/show/NCT00960999.

hOSPITAlS

Cleveland Clinictaussig Cancer institute9500 Euclid Ave./R35Cleveland, OH 44195216.444.7923

Fairview Hospital18101 Lorain Ave.Cleveland, OH 44111216.476.7000

Hillcrest Hospital6780 Mayfield Rd.Mayfield Heights, OH 44124440.312.4500

BeachwoodFamily Health and Surgery Center26900 Cedar Rd.Beachwood, OH 44122216.839.3000 or 800.801.2233

independenceCancer Center6100 Westcreek Rd.Ste. 15 & 16Independence, OH 44131216.524.7979, Medical Oncology216.447.9747, Radiation Oncology

lorainFamily Health and Surgery Center5700 Cooper Foster Park Rd.Lorain, OH 44053440.204.7400 or 800.272.2676

ParmaCancer Center6525 Powers Blvd.Parma, OH 44129440.743.4747

strongsvilleFamily Health and Surgery Center16761 SouthPark CenterStrongsville, OH 44136440.878.2500 or 800.239.1098

Willoughby HillsFamily Health Center2570 SOM Center Rd.Willoughby Hills, OH 44094440.943.2500 or 800.807.2888

WoosterFamily Health Center1740 Cleveland Rd.Wooster, OH 44691330.287.4500 or 800.451.9870

CAnCER CARE lOCATIOnS


“Patient data is one of the most important proper-

ties of Cleveland Clinic because it provides a solid

foundation for outcomes research,” she says. “If

we are to advance the care of patients, we have to

look retrospectively at how all of our new technolo-

gy is impacting patients in terms of the length and

quality of their lives.” Cleveland Clinic’s leadership

in implementing the electronic medical record

was a key factor in luring Dr. Xia from California to

Ohio as the first female head of Medical Physics.

Dr. Xia sees the role of her team of physicists

as helping radiation oncologists solve clinical

problems and speeding the implementation of

new findings into practice. With the evolution of

intensity modulated radiation therapy (IMRT) and

recent advances in image-guided radiation therapy

(IGRT), Dr. Xia says her team is focusing on motion

management, or adaptive therapy. “We know the

patient is a dynamic target,” she says. “We have to

determine the best way to use new technology to

individualize radiation oncology.”

Dr. Xia shared her insights in an education course

at ASTRO, “Transitioning from 3D IMRT to 4D

IMRT and the Roles of Image Guidance,” with co-

presenter Peter Balter, PhD, from M.D. Anderson

Cancer Center. Dr. Xia focused on how IGRT and

4D CT technologies can be used to improve dose

delivery precision and accuracy, particularly with

dynamically changing tumor volumes.

“In the old days, we treated large fields,” she says.

“We cast a net so big that anything within it would

be affected.” IMRT opened the possibility of con-

formal dose distributions to tumors of nearly any

shape. But conformal treatment presented its own

challenges.

“We could precisely target the tumor and spare

surrounding tissue, but if the tumor moved, we’d

miss it,” she says. The advantages of conformal

dose distribution can only be realized if radiation

oncologists can precisely associate the patient’s

anatomy with delivered dose in both spatial and

temporal fashion. Today, 4D planning includes

incorporating changes in patient anatomy into

treatment planning.

Drs. Xia and Balter examined lung, prostate, and

head and neck cancers to illustrate technical

challenges when tumors change by the second,

day or week. “Organ movements and anatomic

changes in patients require us to explicitly include

a time variable into both planning and delivery,”

says Dr. Xia.

Radiation Oncology Welcomes new Head of Medical Physics

When Ping Xia, PhD, came to Cleveland Clinic from the University of

California, San Francisco to head Medical Physics in the Department of

Radiation Oncology, she welcomed the chance to advance research.

Clinical Requirements of iMRt (time scale)

lung tumor

(second)

Prostate

(day)

Head and Neck

(week)

For more information, contact Dr. Xia at [email protected].


Cancer Consult provides information from Cleveland Clinic Taussig Cancer Institute specialists about innovative research and diagnostic and management techniques.

Please direct correspondence to John Suh, MD, Guest Medical Editor [email protected]

Taussig Cancer Institute/R35 Cleveland Clinic 9500 Euclid Avenue Cleveland, OH 44195

Cleveland Clinic Taussig Cancer Institute annually serves more than 26,000 cancer patients. More than 250 cancer specialists are committed to researching and applying the latest, most effective techniques for diagnosis and treatment to achieve long-term survival and improved quality of life for all cancer patients. Taussig Cancer Institute is part of Cleveland Clinic, an independent, not-for-profit, multispe-cialty academic medical center.

Cancer Consult guest Medical EditorJohn Suh, MD, Chairman,Radiation Oncology

Cancer Consult Editorial Board

Derek Raghavan, MD, PhD, Chairman, Taussig Cancer Institute

Brian Bolwell, MD, Chairman,Hematologic Oncology and Blood Disorders

Robert Dreicer, MD, Chairman, Solid Tumor Oncology

Brian Rini, MD Solid Tumor OncologyMedical Editor

Timothy Spiro, MD, Chairman, Regional Oncology

Gene Barnett, MD, Director, Brain Tumor and Neuro-Oncology Center

Eric Klein, MD, Chairman, Urologic Oncology,Glickman Urological & Kidney Institute

Managing Editor Marjie Heines

DesignerAmy Buskey-Wood

PhotographyRussell Lee, Tom Merce

MarketingLori Schmitt, RN, Andrew Kraynak,Melissa Mason

Cancer Consult is written for physicians and should be relied upon for medical education purposes only. It does not provide a complete overview of the topics covered and should not replace the independent judgment of a physician about the appropriateness or risks of a procedure for a given patient.

© 2010 The Cleveland Clinic Foundation

09-CNR-023

IGRT provides better defined margins and more

precise patient positioning, as well as better

localization of the target during treatment. But Dr.

Xia cautions that no single IGRT tool can address

all clinical issues. Each new tool must be carefully

evaluated to determine its usefulness in various

tumor types.

Dr. Xia is active in the Radiation Therapy Oncology

Group and says she plans to continue her study on

the development of 4D radiation therapy, includ-

ing deformable image registration to expedite

contouring in treatment planning, 4D planning

and 4D treatment delivery.

Why 4D Delivery?

• Track fast moving organs: adjust treatment

portals during treatment.

• Adapt to daily changes of the organ filling

(such as the bladder and rectum): adjust

treatment positions prior to treatment.

• Adapt to slow anatomy changes in head

and neck patients: adjust treatment plans

periodically during the treatment course.

Clinical TrialsDirectory Now Online

Radiation Therapy Oncology group (RTOg) Trials Open to Enrollment

RTOG 0227

Phase I/II study of pre-irradiation chemo-therapy with methotrexate, rituximab, and temozolomide and post-irradiation temozolomide for primary central nervous system lymphoma

RTOG 0413

A randomized Phase III study of conventional whole breast irradiation (WBI) versus partial breast irradiation (PBI) for women with stage 0, I, or II breast cancer

RTOG 0433

A Phase III international randomized trial of single versus multiple fractions for re-irradiation of painful bone metastases

RTOG 0436

A Phase III trial evaluating the addition of cetuximab to paclitaxel, cisplatin, and radiation for patients with esophageal cancer who are treated without surgery

RTOG 0534

A Phase III trial of short-term androgen deprivation with pelvic lymphnode or prostate bed only radiotherapy (SPPORT) in prostate cancer patients with a rising psa after radical prostatectomy

RTOG 0538

Phase III comparison of thoracic radiotherapy regimens in patients with limited small cell lung cancer also receiving cisplatin and etoposide

RTOG 0614

A randomized, Phase III, double-blind, placebo-controlled trial of memantine for prevention of cognitive dysfunction in patients receiving whole-brain radiotherapy

RTOG 0617

A randomized Phase III comparison of standard-dose (60 gy) versus high-dose (74 gy) conformal radiotherapy with concurrent and consolidation carboplatin/paclitaxel +/- cetuximab (IND #103444) in patients with stage IIIA/IIIB non-small cell lung cancer

RTOG 0619

A randomized Phase II trial of chemo-radiotherapy versus chemoradiotherapy and vandetanib for high-risk postoperative advanced squamous cell carcinoma of the head and neck

RTOG 0825

Phase III double-blind placebo-controlledtrial of conventional concurrent chemo-radiation and adjuvant temozolomide plus bevacizumab versus conventional concurrent chemoradiation and adjuvant temozolomide in patients with newly diagnosed glioblastoma

RTOG 0813

Seamless Phase I/II study of stereotactic lung radiotherapy (sbrt) for early-stage, centrally located, non-small cell lung cancer (NSCLC) in medically inoperable patients

Cleveland Clinic Taussig Cancer Institute offers an online tool for physicians, patients and caregivers to search for open clinical trials. The web-based clinical trials database lists all of the trials being managed by oncologists in the Taussig Cancer Institute that are accepting patients. At any given time, several hundred cancer clinical trials are under way on the man campus, and at Hillcrest and Fairview hospitals.

To search the database, visit clevelandclinic.org /cancerclinicaltrials


Critical to taussig Cancer institute’s success is the complete partnership established

with Cleveland Clinic’s nationally recognized teams of cancer care specialists. the

following leaders from other Cleveland Clinic institutes collaborate with taussig staff

to provide the most advanced oncologic care to our patients:

Cole Eye instituteArun Singh, MD

Dermatology & Plastic surgery instituteAllison Vidimos, MDPhilip Bailin, MD, MBAWilma Bergfeld, MDChristopher Gasbarre, DODavid Hamrock, MDDouglas Kress, MDEdward Maytin, MD, PhD Jonelle McDonnell, MDJon Meine, MDMelissa Piliang, MD Christine Poblete-Lopez, MDApra Sood, MDJames Taylor, MD Kenneth Tomecki, MD

Digestive Disease instituteFederico Aucejo, MDCarol Burke, MDSricharan Chalikonda, MDJames Church, MDGary Falk, MDVictor W. Fazio, MDJohn Fung, MD, PhDMichael Johnson, MDMatthew Kalady, MDIan Lavery, MD, BSK.V. Narayanan Menon, MDJames Merlino, MDCharles Miller, MDFeza H. Remzi, MDMatthew R. Walsh, MD

Endocrinology & Metabolism instituteAllan Siperstein, MD

glickman Urological & Kidney instituteRyan Berglund, MDSteven Campbell, MD, PhDKhaled Fareed, MDAmr Fergany, MDMichael Gong, MD, PhDJ. Stephen Jones, MD, FACSJihad Kaouk, MDEric Klein, MDDavid Levy, MDCharles S. Modlin, Jr., MDRobert Stein, MDAndrew J. Stephenson, MDJames C. Ulchaker, MD

Head & Neck instituteDaniel Alam, MDMichael Benninger, MDBrian Burkey, MDTodd Coy, DMDHusam Elias, MD, DMDMichael Fritz, MDMichael Huband, DDSP. Daniel Knott, MDJoseph Scharpf, MDPeter Weber, MDBenjamin Wood, MD

Miller Family Heart & Vascular instituteThomas Rice, MDDavid Mason, MDSudish Murthy, MD

Neurological instituteManmeet Ahluwalia, MDLilyana Angelov, MDGene Barnett, MDSamuel Chao, MDBruce Cohen, MDJoung Lee, MDJeremy Rich, MDBurak Sade, MDGlen H. Stevens, DO, PhDTanya Tekautz, MDMichael Vogelbaum, MD, PhDRobert Weil, MD

Ob/gyn & Women’s Health instituteJoseph Crowe, MDJill Dietz, MDRichard Drake, MDPedro Escobar, MDAlicia Fanning, MDKatherine Lee, MDLawrence Levy, MDChad Michener, MDHolly Pederson, MDPeter Rose, MDRobyn Stewart, MD

Orthopaedic & Rheumatologic institute Michael Joyce, MDSteven Lietman, MD

Pulmonary instituteRendell Aston, MDThomas Gildea, MDMichael Machuzak, MDPeter Mazzone, MDMadhu Sasidhar, MD

Pediatric institute & Children’s HospitalL. Kate Gowans, MDEric Kodish, MDMichael Levien, MDGregory Plautz, MDTanya Tekautz, MDMargaret Thompson, MD, PhD

Boutros J, Almasan A. Combining 2-deoxy-D-glucose with electron transport chain blockers: A double-edged sword. Cancer Biol Ther, Vol 8, Issue 13: 1241 – 1242, July 1, 2009.

Burdick MJ, Macklis, RM. Update on the Rational Use of Tositumomab and Iodine-131 Tositumomab Radioimmunotherapy for the Treatment of Non-Hodgkin’s Lymphoma. Oncotargets and Therapy. 2009: 2, 229-242.

Burdick MJ, Reddy CA, Ulchaker J, Angermeier K, Altman A, Chehade N, Mahadevan A, Kupelian PA, Klein EA, Ciezki JP. Comparison of Biochemical Relapse Free Survival between Primary Gleason 3 and Primary Gleason 4 for Biopsy Gleason 7 Prostate Cancer. Int J Radiat Oncol Biol Phys. 73(5):1439-45, 2009.

Cheng S, Iannettoni, Koshy M, Suntha M, Urba S. Squamous Cell Carcinoma of the Esophagus: Treat with How Many Modalities? 36:6, pp. 493-497. Seminars in Oncology, December 2009.

Chow E, James J, Barsevick A, Hartsell W, Ratcliffe S, Scarantino C, Ivker R, Roach M, Suh J, Peterson I, Konski A, Demas W, Bruner D. Functional interference clusters in cancer patients with bone metastases: A Secondary Analysis of RTOG 9714. Int J Radiat Oncol Biol Phys. E pub 24 July 2009.

Chow E, James J, Barsevick A, Hartsell W, Ratcliffe S, Scarantino C, Ivker R, Suh J, Peterson I, Konski A, Demas W, Bruner D. Confirmatory factor analysis of brief pain inventory (BPI) functional interference clustes in patients with bone metastases. J Pain Manage 2010; 3 (4).

Chung HT, Xia P, Chan L, Park-Somers E, Roach III, M. Does IGRT improve the toxicity profile in whole pelvic-treated high-risk prostate cancer? A comparison between IG-IMRT and IMRT. Int J Radiat Oncol Biol Phys 73(1):53-60 (2009).

Ciezki JP. Brachytherapy for Localized Prostate Cancer. Urology. 73(3):473-475, 2009.

Gerbi BJ, Antolak JA, Deibel FC. Followill DS, Herman MG, Higgins PD, Huq MS, Mihailidis DN, Yorke, ED. Recommendations for clinical electron beam dosimetry: supplement to the recommendations of Task Group 25. Med. Phys. 36, 3239-79 (2009).

Glinskii AB, Glinsky GV, Lin HY, Tang HY, Sun M, Davis FB, Luidens MK, Mousa SA, Hercbergs AH, Davis PJ. Modification of survival pathway gene expression in human breast cancer cells by tetraiodothyroacetic acid (tetrac). Cell Cycle. 2009 Nov 1;8(21) 3554-3562.

Hercbergs A, Davis PJ, Davis FB. Cieslieski M, and Leith JT. Radiosensitization of GL261 Glioma Cells by Tetrac (Tetraiodothyroacetic acid). Cell Cycle 2009 Aug 15; 8(16) 2586-2591

Hwang AB, Bacharach SL, Yom SS, Weinberg VK, Quivey JM, Franc BL, Xia P. Can PET or PET/CT Acquired in a Non-Treatment Position Be Accurately Registered to a Head and Neck Radiation Therapy Planning CT? Int J Radiat Oncol Biol Phys 73(2):578-84 (2009).

Koyfman SA, McCabe MS, Emanuel EJ, Grady, C. A Consent Form Template for Phase 1 Oncology Trials. IRB: Ethics & Human Research 31, No. 4 (2009): 1-8.

Khan MK, Hunter GK, Vogelbaum M, Suh JH, Chao ST. Evidence-Based Adjuvant Therapy for Gliomas: Current Concepts and Newer Developments. Indian J. Cancer. Apr-Jun:46(2);96-107, 2009.

Klein EA, Ciezki J, Kupelian PA, Mahadevan A. Outcomes for intermediate risk prostate cancer: are there advantages for surgery, external radiation, or brachytherapy? Urologic Oncology: Seminars and Original Investigations. 27(1): 671-71, 2009.

Lee N, Harris J, Garden AS, Straube W, Glisson BS, Xia P, Bosch W, Morrison WH, Quivey J, Thorstad W, Jones C, Ang KK. Intensity-Modulated Radiation Therapy with or without Chemotherapy for Nasopharyngeal Carcinoma: Radiation Therapy Oncology Group (RTOG) Phase II Trial 0225. J of Clinl Oncol, 27(22):3684-90 (2009).

Lin HY, Davis PJ, Tang HY, Mousa SA, Luidens MK, Hercbergs AH, Davis FB. The pro-apoptotic action of stilbene-induced COX-2 in cancer cells: Convergence with the anti-apoptotic effect of thyroid hormone. Cell Cycle 2009 June 15; 8 (12) 1877-1882.

Mackley HB, Adelstein JS, Reddy CA, Adelstein DJ, Rice TW, Saxton JP, Videtic GMM. Choice of Radiotherapy Planning Modality Influences Toxicity in the Treatment of Locally Advanced Esophageal Cancer. J Gastrointest Cancer. (published online May 1, 2009)

Mu G and Xia P. A Feasibility Study of Using Conventional Jaws to Deliver Complex IMRT Plans for Head and Neck Cancer. Phys Med Biol, 54 (18):5613-23 (2009).

RADIATIOn OnCOlOgy A Sampling of 2009 Journal Publications

Neznanov N, Gorbachev AA, Neznanova L, Komarov AP, Gurova KV, Gasparian AV, Banerjee AK, Almasan A, Fairchild RL, Andrei V. Gudkov AV (2009). Anti-malaria drug blocks proteotoxic stress response: anti-cancer implications. Cell Cycle. 2009 Dec;8(23):3960-70.

Platta CS, Khuntia D, Mehta, MP, Suh JH. Current Treatment Strategies for Brain Metastasis and Complications from Therapeutic Techniques: A Review of Current Literature. Am J Clin Oncol. (published online Aug 11, 2009)

Rosenberg LA, Prayson RA Lee J, Reddy C, Chao ST, Barnett GH, Vogelbaum MA, Suh JH. Long-term experience with World Health Organizations Grade III (Malignant) Meningiomas at a Single Institution. Int J Radiation Oncology Biol Phys., 74:427-432, 2009.

Serago CF, Adnani N, Bank MI, BenComo JA, Duan J, Fairobent L, Freedman DJ, Halvorsen PH, Hendee WR, Herman MG, Morse RK, Mower HW, Pfeiffer DE, Root WJ, Sherouse GW, Vossler MK, Wallace RE, Walters B. Code of Ethics for the American Association of Physicists in Medicine: Report of Task Group 109. Medical Physics 36:213-223, 2009.

Stephans KL, Reddy CA, Djemil T, Gajdos SM, Kolar M, Murthy S, Mason D, Mekhail T, Rice T, Videtic GMM. A Comparison of Two Stereotactic Body Radiation (SBRT) Fractionation Schedules for Medically Inoperable Stage I Non-Small Cell Lung Cancer (NSCLC): The Cleveland Clinic Experience. J Thorac Oncol 2009;4(8):976-982.

Stephans KL, Djemil T, Reddy C, Gajdos SM, Kolar M, Machuzak M, Mazzone P, Videtic GMM. Comprehensive Analysis of Pulmonary Function Test (PFT) Changes after Stereotactic Body Radiotherapy (SBRT) for Stage I Lung Cancer in Medically Inoperable Patients, J Thorac Oncol 2009; 4(7):838-844.

Stephenson AJ, Jones JS, Hernandez AV, Ciezki JP, Gong MC, Klein EA. Analysis of T1c Prostate Cancers Treated at Very Low Prostate-Specific Antigen Levels. European Urology. 5(3):610-616, 2009.

Stone NN, Potters L, Davis BJ, Ciezki JP, Zelefsky MJ, Roach M, Shinohara K, Fearn PA, Kattan MW, Stock RG. Multicenter Analysis of Effect of High Biologic Effective Dose on Biochemical Failure And Survival Outcomes In Patients With Gleason Score 7-10 Prostate Cancer Treated With Permanent Prostate Brachytherapy. Int. J. Radiat. Oncol. Biol. Phys. 73(2):341-346, 2009.

Suh JH, Chao ST, Vogelbaum MA. Management of brain metastases. Curr Neurol Neurosci Rep 9:223-230, 2009.

Tendulkar R, Obi B, Macklis R, Crowe R. Preoperative Breast Magnetic Resonance Imaging in Early Breast Cancer: Implications for Partial Breast Irradiation. Cancer 115(8):1621-30, 2009.

Videtic GMM, Reddy CA, Chao ST, Rice TW, Adelstein DJ, Barnett GH, Mekhail TM, Vogelbaum MA, Suh JH. Gender, race and survival: A study in non-small cell lung cancer brain metastases patients utilizing the RTOG RPA classification. Int J Radiat Oncol Biol. 15 November 2009 75(4): 1141-1147

Videtic GM, Gaspar L, Aref A, Germano I, Goldsmith B, Imperato J, Marcus K, McDermott M, McDonald M, Patchell R, Robins HI, Rogers CL, Suh JH, Wolfson A, Wippold FJ, Expert Panel on Radiation Oncology–Brain Metastases. American College of Radiology Appropriateness Criteria on Multiple Brain Metastases. Int J Radiat Oncol Biol Phys 15 November 2009:75 (4): 961-965.

Vitolo V, Millender LE, Quivey JM, Yom, SS, Schechter NR, Jereczek-Fossa BA, Milani F, Orecchia R, Xia P. Assessment of Carotid Artery Dose in the Treatment of Nasopharyngeal Cancer with IMRT Versus Conventional Radiotherapy. Radiother Oncol 90(2):213-20 (2009).

Vogelbaum MA, Berkey B, Peereboom D, Macdonald D, Giannini C, Suh JH, Jenkins R, Herman J, Brown P, Blumenthal DT, Biggs C, Schultz C, Mehta, M. Phase II Trial of Pre-Irradiation and Concurrent Temozolomide in Patients with Newly Diagnosed Anaplastic Oligodendrogliomas and Mixed Anaplastic Oligoastrocytomas: RTOG BR 0131. Neuro Oncol 2009: 11(2): 167-175, 2009.

Yalcin M, Bharali DJ, Lansing L, Dyskin E, Mousa SS, Hercbergs A, Davis FB, Davis PJ, Mousa SA. Tetraidthroacetic Acid (Tetrac) and Tetrac Nanoparticles Inhibit Growth of Human Renal Cell Carcinoma Xenografts. Anticancer Res 29: 3825-3832 (2009).


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Cancer Consult - Cleveland Clinic · (ASTRO) meeting in Chicago in November provides a glimpse into the breakthrough research in which we are involved. We were very well-represented