Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Fludeoxyglucose F18 Positron Emission Tomography Imaging In Assessing Patients Before and After Treatment for Locally Advanced Non-Small Cell Lung Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Biomarker/Laboratory analysis, Diagnostic, Treatment Active 18 and over NCI ACRIN-6668 ACRIN-6668, RTOG-0235, NCT00083083

Objectives

Primary

1. Determine whether peak standardized uptake value (SUV) for fludeoxyglucose F 18 positron emission tomography (FDG-PET) shortly after definitive chemoradiotherapy is predictive of long-term survival of patients with inoperable stage IIB or III non-small cell lung cancer.

Secondary

1. Determine whether max SUV for FDG-PET shortly after definitive chemoradiotherapy is predictive of long-term survival in these patients.
2. Determine whether post-treatment imaging using peak and max SUV for FDG-PET shortly after definitive chemoradiotherapy is predictive of local disease control in these patients.
3. Determine whether pre-treatment imaging using these techniques is predictive of long-term survival and local disease control in these patients.
4. Correlate, if possible, Ki-67 expression with overall survival of patients assessed with these imaging techniques.

Entry Criteria

Disease Characteristics:

• Histologically confirmed non-small cell lung cancer (NSCLC)
  • Clinical stage IIB or III disease
  • No small cell carcinoma
  • No stage IV disease*
  • No diffuse bronchoalveolar subtype
  • No planned definitive surgical resection

   [Note: *Patients with evidence of stage IV disease by positron emission tomography are eligible if the evidence cannot be confirmed by other means AND the physician still plans to proceed with definitive chemoradiation]




• Planning treatment with definitive chemoradiotherapy
  • May be treated on another Radiation Therapy Oncology Group protocol (except phase I studies) OR with conventional concurrent NSCLC chemoradiotherapy
  • Radiotherapy ≥ 60 Gy AND chemotherapy to include concurrent platinum-based therapy



• No brain metastases by head CT scan or MRI

Prior/Concurrent Therapy:

Biologic therapy

• No anticipated use of adjuvant biologic therapy beyond 14 weeks after the completion of radiotherapy

Chemotherapy

• See Disease Characteristics
• No anticipated use of adjuvant chemotherapy beyond 14 weeks after the completion of radiotherapy

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics
• No prior thoracic radiotherapy
• No concurrent intensity-modulated radiotherapy

Surgery

• See Disease Characteristics

Patient Characteristics:

Age

• 18 and over

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• Medically suitable for early concurrent chemoradiotherapy (radiotherapy dose ≥ 60 Gy)
• Able to tolerate positron emission tomography imaging
• No poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL)
• No other malignancy within the past 3 years except basal cell or squamous cell skin cancer or carcinoma in situ
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after study participation

Expected Enrollment

A total of 250 patients (including at least 75 with stage IIB/IIIA disease and at least 75 with stage IIIB disease) will be accrued for this study within 2 years.

Outcomes

Relationship of survival to post-treatment peak standardized uptake value (SUV) as determined by the imaging institution

Relationship of survival to post-treatment max SUV as determined by the imaging institute
Relationship of local control to post-treatment peak and max SUV as determined by the imaging institution
Relationship of survival and of local control to pre-treatment peak and max SUV as determined by the imaging institution
Reliability between peak and max SUV measurements both pre- and post-treatment
Proportion of participants who are either upstaged or downstaged by positron emission tomography scan
Reliability between PET scan-defined response to therapy measurements
Correlation of Ki-67 expression with peak and max pre-treatment SUV
Association between Ki-67 expression and overall survival at 2 years

Outline

This is a diagnostic, multicenter study.

Before starting chemoradiotherapy, patients undergo baseline whole-body positron emission tomography (PET) imaging. Patients receive fludeoxyglucose F 18 (¹⁸FDG) IV followed 50-70 minutes later by PET imaging. Patients then receive concurrent definitive radiotherapy and chemotherapy. Patients enrolled in other treatment-oriented clinical trials receive therapy as per that trial. Other patients receive standard thoracic radiotherapy (dose ≥ 60 Gy) and standard chemotherapy comprising a platin (cisplatin or carboplatin) and a second non-platin, non-gemcitabine drug (etoposide, vinblastine, vinorelbine, paclitaxel, or docetaxel). Approximately 14 weeks after completion of chemoradiotherapy and adjuvant chemotherapy (if given), patients undergo post-treatment ¹⁸FDG-PET imaging.

Patients are followed every 3 months for 2 years and then every 6 months for at least 1 year.

Trial Contact Information

Trial Lead Organizations

American College of Radiology Imaging Network

Mitchell Machtay, MD, Protocol chair		Ph: 215-955-6706; 800-533-3669 Email: mitchell.machtay@mail.tju.edu

Radiation Therapy Oncology Group

Mitchell Machtay, MD, Protocol chair		Ph: 215-955-6706; 800-533-3669 Email: mitchell.machtay@mail.tju.edu

U.S.A.
Alabama
	Birmingham
	Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
		Clinical Trials Office - Lurleen Wallace Comprehensive Cancer	Ph:  205-934-0309
Arizona
	Scottsdale
	Scottsdale Medical Imaging, Limited
		Allison Irving	Ph:  480-425-5000 ext. 5044
California
	Los Angeles
	USC/Norris Comprehensive Cancer Center and Hospital
		Clinical Trials Office - USC/Norris Comprehensive Cancer Center and Hospital	Ph:  323-865-0451
	Sacramento
	Radiological Associates of Sacramento Medical Group at Sutter Cancer Center
		Kim Vagharfard	Ph:  916-454-6699 ext. 80383
			Email: vagharfardk@radiological.com
Connecticut
	New Haven
	Hospital of Saint Raphael
		Clinical Trials Office - Hospital of Saint Raphael	Ph:  203-789-3545
Florida
	Boynton Beach
	Bethesda Comprehensive Cancer Care Center at Bethesda Memorial Hospital
		Clinical Trials Office - Bethesda Comprehensive Cancer Care Center	Ph:  561-374-5020
	Dearfield Beach
	North Broward Medical Center
		Clinical Trials Office - North Broward Medical Center	Ph:  954-941-8300
	Jacksonville
	Integrated Community Oncology Network at Baptist Cancer Institute
		Jan Peer	Ph:  904-202-7027
	Tallahassee
	Tallahassee Memorial Hospital
		Rowena Dimayuga	Ph:  850-431-5262
Illinois
	Chicago
	Rush Cancer Institute at Rush University Medical Center
		Clinical Trials Office - Rush Cancer Institute at Rush University Medical Center	Ph:  312-942-5498
			Email: clinical_trials@rush.edu
Indiana
	Anderson
	Saint John's Cancer Center at Saint John's Medical Center
		Patricia Farran, RN, OCN, CTR RA	Ph:  765-646-8459
			Email: pafarran@sjhsnet.org
	Goshen
	Center for Cancer Care at Goshen General Hospital
		Clinical Trials Office - Center for Cancer Care at Goshen General Hospital	Ph:  574-535-2858
	South Bend
	CCOP - Northern Indiana CR Consortium
		Virginia Bolin	Ph:  800-284-7370
Maryland
	Baltimore
	Greenebaum Cancer Center at University of Maryland Medical Center
		Clinical Trials Office - Greenebaum Cancer Center at University of Maryladn Medical Center	Ph:  800-888-8823
Massachusetts
	Boston
	Beth Israel Deaconess Medical Center
		Clinical Trials Office - Beth Israel Deaconess Medical Center	Ph:  617-667-9925
	Dana-Farber Partners Cancer Care
		Jennifer Curry	Ph:  617-726-3694
	South Weymouth
	South Shore Hospital
		Kelly O'Neil	Ph:  617-376-6400
			Email: koneil@shcpo.shields.com
Michigan
	Detroit
	Josephine Ford Cancer Center at Henry Ford Hospital
		Karen Dziubek	Ph:  313-916-9462 888-734-5322
	Kalamazoo
	West Michigan Cancer Center
		Clinical Trials Office - West Michigan Cancer Center	Ph:  269-373-7458
	Royal Oak
	William Beaumont Hospital - Royal Oak Campus
		Clinical Trials Office - William Beaumont Hospital - Royal Oak Campus	Ph:  248-551-7695
Missouri
	St. Louis
	Mallinckrodt Institute of Radiology at Washington University Medical Center
		Clinical Trials Office - Mallinckrodt Institute of Radiology at Washington University Medical Center	Ph:  314-362-1000
Nevada
	Reno
	Renown Institute for Cancer at Renown Regional Medical Center
		Lynn Jarvis	Ph:  775-982-5842 866-559-0558
			Email: ljarvis@washoehealth.com
New Hampshire
	Lebanon
	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
		Clinical Trials Office - Norris Cotton Cancer Center	Ph:  603-650-7609
			Email: cancerhelp@dartmouth.edu
New Jersey
	Teaneck
	Sister Patricia Lynch Regional Cancer Center at Holy Name Hospital
		Clinical Trials Office - Sister Patricia Lynch Regional Cancer Center at Holy Name Hospital	Ph:  201-833-6312
	Toms River
	J. Phillip Citta Regional Cancer Center at Community Medical Center
		Clinical Trials Office - J. Phillip Citta Regional Cancer Center at Community Medical Center	Ph:  732-818-3882
Ohio
	Akron
	McDowell Cancer Center at Akron General Medical Center
		Kim Surface	Ph:  330-344-6348
	Cleveland
	Cleveland Clinic Cancer Center at Fairview Hospital
		Clinical Trials Office - Cleveland Clinic Cancer Center at Fairview Hospital	Ph:  216-476-9362
	Cleveland Clinic Taussig Cancer Center
		Clinical Trials Office - Cleveland Clinic Taussig Cancer Center	Ph:  866-223-8100
Oklahoma
	Oklahoma City
	Oklahoma University Cancer Institute
		Faraz Masood	Ph:  405-271-5125
Oregon
	Portland
	Oregon Health and Science University Cancer Institute
		Clinical Trials Office - Oregon Health and Science University Cancer Institute	Ph:  503-494-1080
			Email: trials@ohsu.edu
Pennsylvania
	Philadelphia
	Albert Einstein Cancer Center
		Sharon Byrne	Ph:  215-456-6280
	Fox Chase Cancer Center - Philadelphia
		Clinical Trials Office - Fox Chase Cancer Center - Philadelphia	Ph:  215-728-4790
	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
		Clinical Trials Office - Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Ph:  215-955-6084
	Pittsburgh
	UPMC Cancer Centers
		Clinical Trials Office - UPMC Cancer Centers	Ph:  412-647-8073
	Wynnewood
	Lankenau Cancer Center at Lankenau Hospital
		Judith Fanelli	Ph:  610-645-2395
			Email: fanellij@mlhs.org
Rhode Island
	Providence
	Brown University School of Medicine
		Cindy Cobb	Ph:  401-444-4344
	Roger Williams Medical Center
		Cindy Cobb	Ph:  401-444-4344
			Email: ccobb@lifespan.org
South Carolina
	Charleston
	Hollings Cancer Center at Medical University of South Carolina
		Clinical Trials Office - Hollings Cancer Center at Medical University of South Carolina	Ph:  843-792-9321
	Spartanburg
	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
		Clinical Trials Office - Gibbs Regional Cancer Center	Ph:  800-486-5941
Tennessee
	Nashville
	Vanderbilt-Ingram Cancer Center
		Clinical Trials Office - Vanderbilt-Ingram Cancer Center	Ph:  1-800-811-8480;
Texas
	Dallas
	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
		Clinical Trials Office - Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Ph:  866-460-4673; 214-648-7097
	Houston
	M. D. Anderson Cancer Center at University of Texas
		Clinical Trials Office - M. D. Anderson Cancer Center at the University of Texas	Ph:  713-792-3245
Utah
	Salt Lake City
	Huntsman Cancer Institute at University of Utah
		Clinical Trials Office - Huntsman Cancer Institute at University of Utah	Ph:  801-581-4477
			Email: clinical.trials@hci.utah.edu
Virginia
	Richmond
	Bon Secours Cancer Institute at St. Mary's Hospital
		Ann Kaplan	Ph:  804-287-7418
			Email: ann_kaplan@bshsi.com
Wisconsin
	Madison
	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
		Clinical Trials Office - University of Wisconsin Paul P. Carbone Comprehensive Cancer Center	Ph:  608-262-5223
	Waukesha
	Waukesha Memorial Hospital Regional Cancer Center
		Clinical Trials Office - Waukesha Memorial Hospital Regional Cancer Center	Ph:  262-928-7632
Canada
Alberta
	Calgary
	Tom Baker Cancer Centre - Calgary
		Pina Sjoblom	Ph:  403-944-8018
Ontario
	Kitchner
	Grand River Regional Cancer Centre at Grand River Hospital
		Carla Girolametto	Ph:  519-749-4370
Republic of Korea
	Goyang
	National Cancer Center - Korea
		Hyang Kang	Ph:  82-31-920-0146
			Email: nccrtog@ncc.re.kr

Registry Information
Official Title		Positron Emission Tomography Pre- and Post-treatment Assessment For Locally Advanced Non-Small Cell Lung Carcinoma
Trial Start Date		2005-03-01
Registered in ClinicalTrials.gov		NCT00083083
Date Submitted to PDQ		2004-03-17
Information Last Verified		2007-10-29
NCI Grant/Contract Number		CA080098

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