Official Title: “A Phase II/III Randomized Trial Of Two Dose Schedules For Delivering Prophylactic Cranial Irradiation For Patients With Limited Disease Small Cell Lung Cancer”

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which radiation therapy regimen is more effective in preventing brain metastases in patients with limited-stage small cell lung cancer.

PURPOSE: This randomized phase II/III trial is studying how well brain irradiation works and compares three different brain irradiation regimens in preventing brain metastases in patients with limited-stage small cell lung cancer.

Study Type: Interventional

Study Design: Treatment, Randomized, Active Control

OBJECTIVES: - Compare the incidence of brain metastases in patients with limited stage small cell lung cancer treated with different regimens of prophylactic cranial irradiation. (phase III closed to accrual as of 12/31/05) - Compare the overall and disease-free survival of patients treated with these regimens. (phase III closed to accrual as of 12/31/05) - Compare the incidence of chronic neurotoxicity in patients treated with these regimens. - Compare quality of life and late treatment sequelae of patients treated with these regimens. (phase III closed to accrual as of 12/31/05)

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (60 and under vs over 60) and time since induction therapy (90 days or less vs 91-180 days vs 181-240 days). Patients are randomized to 1 of 3 treatment arms. - Arm I: Patients undergo prophylactic cranial irradiation (PCI) once daily 5 days a week.

Treatment continues for 2 weeks in the absence of unacceptable toxicity. - Arm II: Patients undergo PCI once daily 5 days a week. Treatment continues for 2.6 weeks in the absence of unacceptable toxicity. - Arm III: Patients undergo PCI twice daily 5 days a week. Treatment continues for 3.4 weeks in the absence of unacceptable toxicity.

Quality of life is assessed at baseline, every 6 months for 1 year, and then annually for 3 years.

Patients are followed every 6 months for 1 year and then annually for 3 years.

PROJECTED ACCRUAL: A total of 264 patients will be accrued for this study within 3.5 years.

Primary:

• Brain metastases at 2 years after treatment No
• Overall survival at 2 years after treatment No
• Disease-free survival at 2 years after treatment No

Secondary:

• Quality of life by EORTC Quality of Life Questionnaire and Brain Cancer Module at 6 and 12 months after treatment and then annually No
• Neurotoxicity by LENT-SOMA scale annually after treatment Yes
• Cognitive deficits by Neuropsychological Test Battery at 6 months after treatment and then annually No

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed small cell lung cancer by fine needle aspiration, biopsy, or 2 positive sputa
• Limited stage (I-IIIB)
• Confined to 1 hemithorax
• No T4 or N3 disease
• Complete response after induction chemotherapy (with or without thoracic radiotherapy)
• Consolidative chest radiotherapy may be initiated before study
• No radiographic evidence of any of the following:
• Brain metastases
• Normal brain CT scan or MRI less than 1 month before study
• Ipsilateral lung metastases
• Malignant pleural effusion
• Minimal pleural effusion by chest CT scan allowed, but not by chest x-ray

PATIENT CHARACTERISTICS:

• Age
• Not specified
• Performance status
• Zubrod 0-1
• Life expectancy
• Not specified
• Hematopoietic
• Absolute granulocyte count at least 1,500/mm^3
• Platelet count at least 75,000/mm^3
• Hemoglobin at least 10.0 g/dL^
• Hepatic
• Not specified
• Renal
• Not specified
• Pulmonary
• See Disease Characteristics
• Other
• Not pregnant or nursing
• Fertile patients must use effective contraception
• Neurological function class 1 or 2
• No epilepsy requiring permanent oral medication
• No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
• No other serious medical or psychiatric condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

• Biologic therapy
• Not specified
• Chemotherapy
• See Disease Characteristics
• At least 1 week since prior chemotherapy
• No concurrent chemotherapy
• Endocrine therapy
• Not specified
• Radiotherapy
• See Disease Characteristics
• No prior external beam radiotherapy to the head or neck, including stereotactic radiotherapy
• Concurrent thoracic radiotherapy allowed
• Surgery
• Not specified
• Other
• No concurrent antitumor agents

Lead Sponsor: Radiation Therapy Oncology Group

Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham

Birmingham Alabama 35294 United States

Arizona Oncology Services Foundation

Phoenix Arizona 85013 United States

Virginia G. Piper Cancer Center at Scottsdale Healthcare - Osborn

Scottsdale Arizona 85251 United States

Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea

Scottsdale Arizona 85260 United States

Highlands Oncology Group - Springdale

Springdale Arkansas 72764 United States

Auburn Radiation Oncology

Auburn California 95603 United States

CCOP - Bay Area Tumor Institute

Oakland California 94609 United States

Mercy General Hospital

Sacramento California 95819 United States

Radiation Oncology Center - Roseville

Roseville California 95661 United States

Radiation Oncology Centers - Cameron Park

Cameron Park California 95682 United States

Radiological Associates of Sacramento Medical Group, Incorporated

Sacramento California 95815 United States

Rebecca and John Moores UCSD Cancer Center

La Jolla California 92093-0658 United States

Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center

Pomona California 91767 United States

Solano Radiation Oncology Center

Vacaville California 95687 United States

Memorial Hospital Cancer Center - Colorado Springs

Colorado Springs Colorado 80909 United States

St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center

Grand Junction Colorado 81502 United States

CCOP - Christiana Care Health Services

Newark Delaware 19713 United States

Tunnell Cancer Center at Beebe Medical Center

Lewes Delaware 19958 United States

Baptist-South Miami Regional Cancer Program

Miami Florida 33176 United States

Bay Medical

Panama City Florida 32401 United States

University of Florida Shands Cancer Center

Gainesville Florida 32610-0232 United States

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami Florida 33136 United States

Northeast Georgia Medical Center

Gainesville Georgia 30501 United States

BroMenn Regional Medical Center

Normal Illinois 61761 United States

Cancer Treatment Center at Pekin Hospital

Pekin Illinois 61554 United States

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood Illinois 60153 United States

Carle Cancer Center at Carle Foundation Hospital

Urbana Illinois 61801 United States

CCOP - Carle Cancer Center

Urbana Illinois 61801 United States

CCOP - Illinois Oncology Research Association

Peoria Illinois 61615 United States

Community Cancer Center

Normal Illinois 61761 United States

Community Hospital of Ottawa

Ottawa Illinois 61350 United States

Eureka Community Hospital

Eureka Illinois 61530 United States

Galesburg Clinic, PC

Galesburg Illinois 61401 United States

Galesburg Cottage Hospital

Galesburg Illinois 61401 United States

Graham Hospital

Canton Illinois 61520 United States

Hopedale Medical Complex

Hopedale Illinois 61747 United States

Illinois Valley Community Hospital

Peru Illinois 61354 United States

InterCommunity Cancer Center of Western Illinois

Galesburg Illinois 61401 United States

Joliet Oncology-Hematology Associates, Limited - West

Joliet Illinois 60435 United States

Kewanee Hospital

Kewanee Illinois 61443 United States

La Grange Memorial Hospital

La Grange Illinois 60525 United States

Mason District Hospital

Havana Illinois 62644 United States

McDonough District Hospital

Macomb Illinois 61455 United States

Memorial Hospital

Carthage Illinois 62321 United States

Methodist Medical Center of Illinois

Peoria Illinois 61636 United States

Northwest Community Hospital

Arlington Heights Illinois 60005 United States

Oncology Hematology Associates of Central Illinois, PC - Peoria

Peoria Illinois 61615 United States

OSF St. Francis Medical Center

Peoria Illinois 61637 United States

Perry Memorial Hospital

Princeton Illinois 61356 United States

Proctor Hospital

Peoria Illinois 61614 United States

Rush-Copley Cancer Care Center

Aurora Illinois 60507 United States

St. Anthony's Memorial Hospital

Effingham Illinois 62401 United States

St. Joseph Medical Center

Bloomington Illinois 61701 United States

St. Margaret's Hospital

Spring Valley Illinois 61362 United States

Valley Cancer Center

Spring Valley Illinois 61362 United States

Cancer Center at Ball Memorial Hospital

Muncie Indiana 47303-3499 United States

Center for Cancer Therapy at LaPorte Hospital and Health Services

La Porte Indiana 46350 United States

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis Indiana 46202-5289 United States

Memorial Hospital of South Bend

South Bend Indiana 46601 United States

Parkview Regional Cancer Center at Parkview Health

Fort Wayne Indiana 46805 United States

Saint Anthony Memorial Health Centers

Michigan City Indiana 46360 United States

Saint John's Cancer Center at Saint John's Medical Center

Anderson Indiana 46016 United States

Veterans Affairs Medical Center - Indianapolis

Indianapolis Indiana 46202 United States

Holden Comprehensive Cancer Center at University of Iowa

Iowa City Iowa 52242-1002 United States

McFarland Clinic, PC

Ames Iowa 50010 United States

Associates in Womens Health, PA - North Review

Wichita Kansas 67203 United States

Cancer Center of Kansas, PA - Kingman

Kingman Kansas 67068 United States

Cancer Center of Kansas, PA - Wichita

Wichita Kansas 67214 United States

Cancer Center of Kansas, PA - Chanute

Chanute Kansas 66720 United States

Cancer Center of Kansas, PA - Dodge City

Dodge City Kansas 67801 United States

Cancer Center of Kansas, PA - El Dorado

El Dorado Kansas 67042 United States

Cancer Center of Kansas, PA - Medical Arts Tower

Wichita Kansas 67208 United States

Cancer Center of Kansas, PA - Newton

Newton Kansas 67114 United States

Cancer Center of Kansas, PA - Parsons

Parsons Kansas 67357 United States

Cancer Center of Kansas, PA - Pratt

Pratt Kansas 67124 United States

Cancer Center of Kansas, PA - Salina

Salina Kansas 67042 United States

Cancer Center of Kansas, PA - Wellington

Wellington Kansas 67152 United States

Cancer Center of Kansas, PA - Winfield

Winfield Kansas 67156 United States

CCOP - Wichita

Wichita Kansas 67214 United States

Cotton-O'Neil Cancer Center

Topeka Kansas 66606 United States

Southwest Medical Center

Liberal Kansas 67901 United States

St. Francis Comprehensive Cancer Center

Topeka Kansas 66606 United States

Via Christi Cancer Center at Via Christi Regional Medical Center

Wichita Kansas 67214 United States

Wesley Medical Center

Wichita Kansas 67214 United States

Lucille P. Markey Cancer Center at University of Kentucky

Lexington Kentucky 40536-0093 United States

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore Maryland 21201 United States

Union Hospital Cancer Program at Union Hospital

Elkton MD Maryland 21921 United States

Boston University Cancer Research Center

Boston Massachusetts 02118 United States

Hudner Oncology Center at Saint Anne's Hospital - Fall River

Fall River Massachusetts 02721 United States

South Suburban Oncology Center

Quincy Massachusetts 02169 United States

Barbara Ann Karmanos Cancer Institute

Detroit Michigan 48201-1379 United States

Battle Creek Health System Cancer Care Center

Battle Creek Michigan 49017 United States

Borgess Medical Center

Kalamazoo Michigan 49001 United States

Bronson Methodist Hospital

Kalamazoo Michigan 49007 United States

Butterworth Hospital at Spectrum Health

Grand Rapids Michigan 49503 United States

CCOP - Grand Rapids

Grand Rapids Michigan 49503 United States

Hackley Hospital

Muskegon Michigan 49442 United States

Hickman Cancer Center at Bixby Medical Center

Adrian Michigan 49221 United States

Holland Community Hospital

Holland Michigan 49423 United States

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit Michigan 48202 United States

Lacks Cancer Center at Saint Mary's Health Care

Grand Rapids Michigan 49503 United States

Lakeland Regional Cancer Care Center - St. Joseph

St. Joseph Michigan 49085 United States

Mecosta County Medical Center

Big Rapids Michigan 49307 United States

Metro Health Hospital

Grand Rapids Michigan 49506 United States

Munson Medical Center

Traverse City Michigan 49684 United States

University of Michigan Comprehensive Cancer Center

Ann Arbor Michigan 48109-0942 United States

Veterans Affairs Medical Center - Ann Arbor

Ann Arbor Michigan 48105 United States

West Michigan Cancer Center

Kalamazoo Michigan 49007-3731 United States

CentraCare Clinic - River Campus

St. Cloud Minnesota 56303 United States

Immanuel St. Joseph's

Mankato Minnesota 56002 United States

Regional Cancer Center at Singing River Hospital

Pascagoula Mississippi 39581 United States

Cancer Institute of Cape Girardeau, LLC

Cape Girardeau Missouri 63703 United States

CCOP - St. Louis-Cape Girardeau

St. Louis Missouri 63141 United States

CCOP - Nevada Cancer Research Foundation

Las Vegas Nevada 89106 United States

Radiation Oncology Associates - Reno

Reno Nevada 89509 United States

University Medical Center of Southern Nevada

Las Vegas Nevada 89102 United States

Booker Cancer Center at Riverview Medical Center

Red Bank New Jersey 07701 United States

Cancer Institute of New Jersey at Cooper - Voorhees

Voorhees New Jersey 08043 United States

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton

Marlton New Jersey 08053 United States

Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare

Vineland New Jersey 08360 United States

Frederick R. and Betty M. Smith Cancer Treatment Center

Sparta New Jersey 07871 United States

J. Phillip Citta Regional Cancer Center at Community Medical Center

Toms River New Jersey 08755 United States

John F. Kennedy Medical Center

Edison New Jersey 08818 United States

Monmouth Medical Center

Long Branch New Jersey 07740-6395 United States

Ocean Medical Center at Meridian Health

Brick New Jersey 08724 United States

Highland Hospital of Rochester

Rochester New York 14620 United States

Hudson Valley Oncology Associates

Poughkeepsie New York 12601 United States

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester New York 14642 United States

Roswell Park Cancer Institute

Buffalo New York 14263-0001 United States

SUNY Upstate Medical University Hospital

Syracuse New York 13210 United States

Tucker Center for Cancer Care at Orange Regional Medical Center

Middletown New York 10940-4199 United States

Iredell Memorial Hospital

Statesville North Carolina 28677 United States

Kinston Medical Specialists

Kinston North Carolina 28501 United States

Leo W. Jenkins Cancer Center at ECU Medical School

Greenville North Carolina 27835-6028 United States

Presbyterian Cancer Center at Presbyterian Hospital

Charlotte North Carolina 28233-3549 United States

Wayne Memorial Hospital, Incorporated

Goldsboro North Carolina 27534 United States

Wayne Radiation Oncology

Goldsboro North Carolina 27534 United States

Aultman Cancer Center at Aultman Hospital

Canton Ohio 44710-1799 United States

Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford

Salem Ohio 44460 United States

Cancer Treatment Center

Wooster Ohio 44691 United States

CCOP - Toledo Community Hospital

Toledo Ohio 43617 United States

Charles M. Barrett Cancer Center at University Hospital

Cincinnati Ohio 45267 United States

Cleveland Clinic Taussig Cancer Center

Cleveland Ohio 44195 United States

Euclid Hospital

Cleveland Ohio 44119 United States

Firelands Regional Medical Center

Sandusky Ohio 44870 United States

Flower Hospital Cancer Center

Sylvania Ohio 43560 United States

Hillcrest Cancer Center at Hillcrest Hospital

Mayfield Heights Ohio 44124 United States

Huron Hospital Cancer Care Center

Cleveland Ohio 44112 United States

Lima Memorial Hospital

Lima Ohio 45804 United States

MedCentral - Mansfield Hospital

Mansfield Ohio 44903 United States

Medical University of Ohio Cancer Center

Toledo Ohio 43614 United States

Mercy Hospital of Tiffin

Tiffin Ohio 44883 United States

South Pointe Hospital Cancer Care Center

Warrensville Heights Ohio 44122 United States

St. Charles Mercy Hospital

Oregon Ohio 43616 United States

St. Luke's Hospital

Maumee Ohio 43537 United States

St. Rita's Medical Center

Lima Ohio 45801 United States

St. Vincent Mercy Medical Center

Toledo Ohio 43608 United States

Summa Center for Cancer Care at Akron City Hospital

Akron Ohio 44309-2090 United States

Toledo Clinic, Incorporated - Main Clinic

Toledo Ohio 43623 United States

Toledo Hospital

Toledo Ohio 43606 United States

CCOP - Columbia River Oncology Program

Portland Oregon 97225 United States

Dubs Cancer Center at Rogue Valley Medical Center

Medford Oregon 97504 United States

Legacy Emanuel Hospital and Health Center and Children's Hospital

Portland Oregon 97227 United States

Legacy Good Samaritan Hospital & Comprehensive Cancer Center

Portland Oregon 97210 United States

Legacy Meridian Park Hospital

Tualatin Oregon 97062 United States

Legacy Mount Hood Medical Center

Gresham Oregon 97030 United States

Providence Cancer Center at PMCC

Medford Oregon 97504 United States

Providence Cancer Center at Providence Portland Medical Center

Portland Oregon 97213-2967 United States

Providence Milwaukie Hospital

Milwaukie Oregon 97222 United States

Providence St. Vincent Medical Center

Portland Oregon 97225 United States

Three Rivers Community Hospital

Grants Pass Oregon 97527 United States

Albert Einstein Cancer Center

Philadelphia Pennsylvania 19141 United States

Dale and Frances Hughes Cancer Center at Pocono Medical Center

East Stroudsburg Pennsylvania 18301 United States

Fox Chase Cancer Center - Philadelphia

Philadelphia Pennsylvania 19111-2497 United States

Fox Chase Cancer Center CCOP Research Base

Philadelphia Pennsylvania 19140 United States

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia Pennsylvania 19107-5541 United States

McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

Reading Pennsylvania 19612-6052 United States

Penn State Cancer Institute at Milton S. Hershey Medical Center

Hershey Pennsylvania 17033-0850 United States

Rosenfeld Cancer Center at Abington Memorial Hospital

Abington Pennsylvania 19001 United States

St. Luke's Cancer Network at St. Luke's Hospital

Bethlehem Pennsylvania 18015 United States

York Cancer Center at Apple Hill Medical Center

York Pennsylvania 17405 United States

CCOP - Greenville

Greenville South Carolina 29615 United States

Hollings Cancer Center at Medical University of South Carolina

Charleston South Carolina 29425 United States

Rapid City Regional Hospital

Rapid City South Dakota 57701 United States

Arlington Cancer Center - Arlington

Arlington Texas 76012-2510 United States

M. D. Anderson Cancer Center at University of Texas

Houston Texas 77030-4009 United States

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas Texas 75390 United States

Cottonwood Hospital Medical Center

Murray Utah 84107 United States

Dixie Regional Medical Center - East Campus

Saint George Utah 84770 United States

Jon and Karen Huntsman Cancer Center at Intermountain Medical Center

Murray Utah 84157 United States

LDS Hospital

Salt Lake City Utah 84143 United States

Utah Cancer Specialists at UCS Cancer Center

Salt Lake City Utah 84106 United States

Utah Valley Regional Medical Center - Provo

Provo Utah 84604 United States

Val and Ann Browning Cancer Center at McKay-Dee Hospital Center

Ogden Utah 84403 United States

Cancer Care Northwest - Spokane South

Spokane Washington 99202 United States

Fred Hutchinson Cancer Research Center

Seattle Washington 98104 United States

Group Health Central Hospital

Seattle Washington 98112 United States

Harborview Medical Center

Seattle Washington 98104 United States

Harrison Medical Center

Bremerton Washington 98310 United States

Madigan Army Medical Center - Tacoma

Tacoma Washington 98431 United States

Southwest Washington Medical Center Cancer Center

Vancouver Washington 98668 United States

St. Joseph Cancer Center

Bellingham Washington 98225 United States

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Seattle Washington 98122-4307 United States

University Cancer Center at University of Washington Medical Center

Seattle Washington 98195-6043 United States

Wenatchee Valley Medical Center

Wenatchee Washington 98801-2028 United States

Schiffler Cancer Center at Wheeling Hospital

Wheeling West Virginia 26003 United States

All Saints Cancer Center at Wheaton Franciscan Healthcare

Racine Wisconsin 53405 United States

Bay Area Cancer Care Center at Bay Area Medical Center

Marinette Wisconsin 54143 United States

Green Bay Oncology, Limited at St. Mary's Hospital

Green Bay Wisconsin 54303 United States

Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center

Green Bay Wisconsin 54301-3526 United States

Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

La Crosse Wisconsin 54601 United States

Medical College of Wisconsin Cancer Center

Milwaukee Wisconsin 53226 United States

Regional Cancer Center at Oconomowoc Memorial Hospital

Oconomowoc Wisconsin 53066 United States

St. Mary's Hospital Medical Center - Green Bay

Green Bay Wisconsin 54303 United States

St. Vincent Hospital Regional Cancer Center

Green Bay Wisconsin 54307-3508 United States

Veterans Affairs Medical Center - Milwaukee

Milwaukee Wisconsin 53295 United States

Waukesha Memorial Hospital Regional Cancer Center

Waukesha Wisconsin 53188 United States

McGill Cancer Centre at McGill University

Montreal  H2W 1S6 Canada

CancerCare Manitoba

Winnipeg Manitoba R3E 0V9 Canada

Princess Margaret Hospital

Toronto Ontario M5G 2M9 Canada

Centre Hospitalier Universitaire de Quebec

Quebec City Quebec G1R 2J6 Canada

Hopital Notre-Dame du CHUM

Montreal Quebec H2L 4M1 Canada

Overall Clinical Trial Officials and Contacts

Aaron H. Wolfson, MD Study Chair Sylvester Cancer Center  

Information obtained from ClinicalTrials.gov on July 23, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00057746

Study ID Number: CDR0000258668

ClinicalTrials.gov Identifier: NCT00057746

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database