Brain Irradiation in Treating Patients With Limited-Stage Small Cell Lung Cancer
- Conditions
- Lung Cancer
- Interventions
- Radiation: Prophylactic cranial irradiation, 2.0 Gy fxRadiation: Prophylactic cranial irradiation, 2.5 Gy fxRadiation: Prophylactic cranial irradiation, 1.5 Gy fx
- Registration Number
- NCT00057746
- Lead Sponsor
- Radiation Therapy Oncology Group
- Brief Summary
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 while taking into account chronic neurotoxicity from radiation therapy.
PURPOSE: This randomized phase II trial compares the incidence of chronic neurotoxicity between three different brain irradiation regimens. The corresponding phase III component addressing the prevention of brain metastases was run by EORTC and reported separately (NCT00005062).
- Detailed Description
OBJECTIVES:
* Compare the incidence of chronic neurotoxicity in patients treated with these regimens.
* Compare quality of life 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 265
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm II Prophylactic cranial irradiation, 2.0 Gy fx Prophylactic cranial irradiation, 2.0 Gy fx Arm I Prophylactic cranial irradiation, 2.5 Gy fx Prophylactic cranial irradiation, 2.5 Gy fx Arm III Prophylactic cranial irradiation, 1.5 Gy fx Prophylactic cranial irradiation, 1.5 Gy fx
- Primary Outcome Measures
Name Time Method Incidence of Chronic Neurotoxicity From study registration to one year. Chronic neurotoxicity is defined as a drop in one standard error of measurement (SEM) in any one of the three tests comprising the neuropsychological test battery (Hopkins Verbal Learning Test, Controlled Word Association Test, and Trail-Making Test) without development of brain metastasis by one year. The SEM is calculated as the standard deviation of the baseline test multiplied by the square root of one minus the published reliability coefficient for the test.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (222)
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
J. Phillip Citta Regional Cancer Center at Community Medical Center
🇺🇸Toms River, New Jersey, United States
Cancer Institute of New Jersey at Cooper - Voorhees
🇺🇸Voorhees, New Jersey, United States
Boston University Cancer Research Center
🇺🇸Boston, Massachusetts, United States
Euclid Hospital
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
South Pointe Hospital Cancer Care Center
🇺🇸Warrensville Heights, Ohio, United States
Cancer Treatment Center
🇺🇸Wooster, Ohio, United States
Virginia G. Piper Cancer Center at Scottsdale Healthcare - Osborn
🇺🇸Scottsdale, Arizona, United States
Highlands Oncology Group - Springdale
🇺🇸Springdale, Arkansas, United States
Auburn Radiation Oncology
🇺🇸Auburn, California, United States
Rebecca and John Moores UCSD Cancer Center
🇺🇸La Jolla, California, United States
Radiation Oncology Centers - Cameron Park
🇺🇸Cameron Park, California, United States
Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical Center
🇺🇸Pomona, California, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
Solano Radiation Oncology Center
🇺🇸Vacaville, California, United States
Memorial Hospital Cancer Center - Colorado Springs
🇺🇸Colorado Springs, Colorado, United States
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
🇺🇸Grand Junction, Colorado, United States
Tunnell Cancer Center at Beebe Medical Center
🇺🇸Lewes, Delaware, United States
CCOP - Christiana Care Health Services
🇺🇸Newark, Delaware, United States
University of Florida Shands Cancer Center
🇺🇸Gainesville, Florida, United States
Bay Medical
🇺🇸Panama City, Florida, United States
Northeast Georgia Medical Center
🇺🇸Gainesville, Georgia, United States
St. Joseph Medical Center
🇺🇸Bloomington, Illinois, United States
Rush-Copley Cancer Care Center
🇺🇸Aurora, Illinois, United States
Memorial Hospital
🇺🇸Carthage, Illinois, United States
Northwest Community Hospital
🇺🇸Arlington Heights, Illinois, United States
Eureka Community Hospital
🇺🇸Eureka, Illinois, United States
St. Anthony's Memorial Hospital
🇺🇸Effingham, Illinois, United States
Galesburg Clinic, PC
🇺🇸Galesburg, Illinois, United States
Galesburg Cottage Hospital
🇺🇸Galesburg, Illinois, United States
InterCommunity Cancer Center of Western Illinois
🇺🇸Galesburg, Illinois, United States
Hopedale Medical Complex
🇺🇸Hopedale, Illinois, United States
Joliet Oncology-Hematology Associates, Limited - West
🇺🇸Joliet, Illinois, United States
La Grange Memorial Hospital
🇺🇸La Grange, Illinois, United States
Community Cancer Center
🇺🇸Normal, Illinois, United States
Cardinal Bernardin Cancer Center at Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
McDonough District Hospital
🇺🇸Macomb, Illinois, United States
BroMenn Regional Medical Center
🇺🇸Normal, Illinois, United States
Community Hospital of Ottawa
🇺🇸Ottawa, Illinois, United States
Cancer Treatment Center at Pekin Hospital
🇺🇸Pekin, Illinois, United States
Proctor Hospital
🇺🇸Peoria, Illinois, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
OSF St. Francis Medical Center
🇺🇸Peoria, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
🇺🇸Peoria, Illinois, United States
Perry Memorial Hospital
🇺🇸Princeton, Illinois, United States
St. Margaret's Hospital
🇺🇸Spring Valley, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
Saint John's Cancer Center at Saint John's Medical Center
🇺🇸Anderson, Indiana, United States
Parkview Regional Cancer Center at Parkview Health
🇺🇸Fort Wayne, Indiana, United States
Center for Cancer Therapy at LaPorte Hospital and Health Services
🇺🇸La Porte, Indiana, United States
Saint Anthony Memorial Health Centers
🇺🇸Michigan City, Indiana, United States
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
Cancer Center at Ball Memorial Hospital
🇺🇸Muncie, Indiana, United States
Cancer Center of Kansas, PA - Dodge City
🇺🇸Dodge City, Kansas, United States
McFarland Clinic, PC
🇺🇸Ames, Iowa, United States
Holden Comprehensive Cancer Center at University of Iowa
🇺🇸Iowa City, Iowa, United States
Cancer Center of Kansas, PA - Chanute
🇺🇸Chanute, Kansas, United States
Cancer Center of Kansas, PA - El Dorado
🇺🇸El Dorado, Kansas, United States
Cancer Center of Kansas, PA - Wellington
🇺🇸Wellington, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower
🇺🇸Wichita, Kansas, United States
Wesley Medical Center
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Winfield
🇺🇸Winfield, Kansas, United States
Lucille P. Markey Cancer Center at University of Kentucky
🇺🇸Lexington, Kentucky, United States
Greenebaum Cancer Center at University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Union Hospital Cancer Program at Union Hospital
🇺🇸Elkton MD, Maryland, United States
Hudner Oncology Center at Saint Anne's Hospital - Fall River
🇺🇸Fall River, Massachusetts, United States
South Suburban Oncology Center
🇺🇸Quincy, Massachusetts, United States
Hickman Cancer Center at Bixby Medical Center
🇺🇸Adrian, Michigan, United States
Battle Creek Health System Cancer Care Center
🇺🇸Battle Creek, Michigan, United States
Mecosta County Medical Center
🇺🇸Big Rapids, Michigan, United States
Butterworth Hospital at Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
CCOP - Grand Rapids
🇺🇸Grand Rapids, Michigan, United States
Metro Health Hospital
🇺🇸Grand Rapids, Michigan, United States
Lacks Cancer Center at Saint Mary's Health Care
🇺🇸Grand Rapids, Michigan, United States
Holland Community Hospital
🇺🇸Holland, Michigan, United States
Borgess Medical Center
🇺🇸Kalamazoo, Michigan, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
Bronson Methodist Hospital
🇺🇸Kalamazoo, Michigan, United States
Munson Medical Center
🇺🇸Traverse City, Michigan, United States
Hackley Hospital
🇺🇸Muskegon, Michigan, United States
Lakeland Regional Cancer Care Center - St. Joseph
🇺🇸St. Joseph, Michigan, United States
Immanuel St. Joseph's
🇺🇸Mankato, Minnesota, United States
CentraCare Clinic - River Campus
🇺🇸St. Cloud, Minnesota, United States
Regional Cancer Center at Singing River Hospital
🇺🇸Pascagoula, Mississippi, United States
Cancer Institute of Cape Girardeau, LLC
🇺🇸Cape Girardeau, Missouri, United States
CCOP - St. Louis-Cape Girardeau
🇺🇸St. Louis, Missouri, United States
Ocean Medical Center at Meridian Health
🇺🇸Brick, New Jersey, United States
Radiation Oncology Associates - Reno
🇺🇸Reno, Nevada, United States
Monmouth Medical Center
🇺🇸Long Branch, New Jersey, United States
John F. Kennedy Medical Center
🇺🇸Edison, New Jersey, United States
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
🇺🇸Marlton, New Jersey, United States
Booker Cancer Center at Riverview Medical Center
🇺🇸Red Bank, New Jersey, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
Frederick R. and Betty M. Smith Cancer Treatment Center
🇺🇸Sparta, New Jersey, United States
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
🇺🇸Vineland, New Jersey, United States
Tucker Center for Cancer Care at Orange Regional Medical Center
🇺🇸Middletown, New York, United States
Hudson Valley Oncology Associates
🇺🇸Poughkeepsie, New York, United States
Highland Hospital of Rochester
🇺🇸Rochester, New York, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Presbyterian Cancer Center at Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States
SUNY Upstate Medical University Hospital
🇺🇸Syracuse, New York, United States
Wayne Radiation Oncology
🇺🇸Goldsboro, North Carolina, United States
Wayne Memorial Hospital, Incorporated
🇺🇸Goldsboro, North Carolina, United States
Kinston Medical Specialists
🇺🇸Kinston, North Carolina, United States
Iredell Memorial Hospital
🇺🇸Statesville, North Carolina, United States
Leo W. Jenkins Cancer Center at ECU Medical School
🇺🇸Greenville, North Carolina, United States
Summa Center for Cancer Care at Akron City Hospital
🇺🇸Akron, Ohio, United States
Aultman Cancer Center at Aultman Hospital
🇺🇸Canton, Ohio, United States
Huron Hospital Cancer Care Center
🇺🇸Cleveland, Ohio, United States
St. Rita's Medical Center
🇺🇸Lima, Ohio, United States
Lima Memorial Hospital
🇺🇸Lima, Ohio, United States
Hillcrest Cancer Center at Hillcrest Hospital
🇺🇸Mayfield Heights, Ohio, United States
St. Luke's Hospital
🇺🇸Maumee, Ohio, United States
MedCentral - Mansfield Hospital
🇺🇸Mansfield, Ohio, United States
St. Charles Mercy Hospital
🇺🇸Oregon, Ohio, United States
Cancer Research UK Medical Oncology Unit at Churchill Hospital & Weatherall Institute of Molecular Medicine - Oxford
🇺🇸Salem, Ohio, United States
Firelands Regional Medical Center
🇺🇸Sandusky, Ohio, United States
Flower Hospital Cancer Center
🇺🇸Sylvania, Ohio, United States
Mercy Hospital of Tiffin
🇺🇸Tiffin, Ohio, United States
Toledo Hospital
🇺🇸Toledo, Ohio, United States
St. Vincent Mercy Medical Center
🇺🇸Toledo, Ohio, United States
CCOP - Toledo Community Hospital
🇺🇸Toledo, Ohio, United States
Medical University of Ohio Cancer Center
🇺🇸Toledo, Ohio, United States
Toledo Clinic, Incorporated - Main Clinic
🇺🇸Toledo, Ohio, United States
Three Rivers Community Hospital
🇺🇸Grants Pass, Oregon, United States
Dubs Cancer Center at Rogue Valley Medical Center
🇺🇸Medford, Oregon, United States
Legacy Mount Hood Medical Center
🇺🇸Gresham, Oregon, United States
Providence Cancer Center at PMCC
🇺🇸Medford, Oregon, United States
Providence Milwaukie Hospital
🇺🇸Milwaukie, Oregon, United States
Legacy Meridian Park Hospital
🇺🇸Tualatin, Oregon, United States
Rosenfeld Cancer Center at Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
St. Luke's Cancer Network at St. Luke's Hospital
🇺🇸Bethlehem, Pennsylvania, United States
Dale and Frances Hughes Cancer Center at Pocono Medical Center
🇺🇸East Stroudsburg, Pennsylvania, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Fox Chase Cancer Center - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Albert Einstein Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
🇺🇸Reading, Pennsylvania, United States
Fox Chase Cancer Center CCOP Research Base
🇺🇸Philadelphia, Pennsylvania, United States
York Cancer Center at Apple Hill Medical Center
🇺🇸York, Pennsylvania, United States
Hollings Cancer Center at Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
CCOP - Greenville
🇺🇸Greenville, South Carolina, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
Cottonwood Hospital Medical Center
🇺🇸Murray, Utah, United States
Arlington Cancer Center - Arlington
🇺🇸Arlington, Texas, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
🇺🇸Dallas, Texas, United States
M. D. Anderson Cancer Center at University of Texas
🇺🇸Houston, Texas, United States
Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
🇺🇸Murray, Utah, United States
Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
🇺🇸Ogden, Utah, United States
Utah Valley Regional Medical Center - Provo
🇺🇸Provo, Utah, United States
Dixie Regional Medical Center - East Campus
🇺🇸Saint George, Utah, United States
St. Joseph Cancer Center
🇺🇸Bellingham, Washington, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
Group Health Central Hospital
🇺🇸Seattle, Washington, United States
Harrison Medical Center
🇺🇸Bremerton, Washington, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
🇺🇸Seattle, Washington, United States
Cancer Care Northwest - Spokane South
🇺🇸Spokane, Washington, United States
Wenatchee Valley Medical Center
🇺🇸Wenatchee, Washington, United States
University Cancer Center at University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Southwest Washington Medical Center Cancer Center
🇺🇸Vancouver, Washington, United States
Madigan Army Medical Center - Tacoma
🇺🇸Tacoma, Washington, United States
Schiffler Cancer Center at Wheeling Hospital
🇺🇸Wheeling, West Virginia, United States
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
St. Mary's Hospital Medical Center - Green Bay
🇺🇸Green Bay, Wisconsin, United States
Green Bay Oncology, Limited at St. Mary's Hospital
🇺🇸Green Bay, Wisconsin, United States
St. Vincent Hospital Regional Cancer Center
🇺🇸Green Bay, Wisconsin, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
🇺🇸La Crosse, Wisconsin, United States
Bay Area Cancer Care Center at Bay Area Medical Center
🇺🇸Marinette, Wisconsin, United States
Regional Cancer Center at Oconomowoc Memorial Hospital
🇺🇸Oconomowoc, Wisconsin, United States
All Saints Cancer Center at Wheaton Franciscan Healthcare
🇺🇸Racine, Wisconsin, United States
Waukesha Memorial Hospital Regional Cancer Center
🇺🇸Waukesha, Wisconsin, United States
Hopital Notre-Dame du CHUM
🇨🇦Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Quebec
🇨🇦Quebec City, Quebec, Canada
McGill Cancer Centre at McGill University
🇨🇦Montreal, Canada
University of Miami Sylvester Comprehensive Cancer Center - Miami
🇺🇸Miami, Florida, United States
Baptist-South Miami Regional Cancer Program
🇺🇸Miami, Florida, United States
Indiana University Melvin and Bren Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States
Veterans Affairs Medical Center - Indianapolis
🇺🇸Indianapolis, Indiana, United States
University Medical Center of Southern Nevada
🇺🇸Las Vegas, Nevada, United States
CCOP - Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Charles M. Barrett Cancer Center at University Hospital
🇺🇸Cincinnati, Ohio, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Kingman
🇺🇸Kingman, Kansas, United States
Cancer Center of Kansas, PA - Newton
🇺🇸Newton, Kansas, United States
Cancer Center of Kansas, PA - Parsons
🇺🇸Parsons, Kansas, United States
Southwest Medical Center
🇺🇸Liberal, Kansas, United States
Cotton-O'Neil Cancer Center
🇺🇸Topeka, Kansas, United States
Cancer Center of Kansas, PA - Salina
🇺🇸Salina, Kansas, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Pratt
🇺🇸Pratt, Kansas, United States
Cancer Center of Kansas, PA - Wichita
🇺🇸Wichita, Kansas, United States
CancerCare Manitoba
🇨🇦Winnipeg, Manitoba, Canada
St. Francis Comprehensive Cancer Center
🇺🇸Topeka, Kansas, United States
Graham Hospital
🇺🇸Canton, Illinois, United States
Arizona Oncology Services Foundation
🇺🇸Phoenix, Arizona, United States
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Josephine Ford Cancer Center at Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Utah Cancer Specialists at UCS Cancer Center
🇺🇸Salt Lake City, Utah, United States
LDS Hospital
🇺🇸Salt Lake City, Utah, United States
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
🇺🇸Birmingham, Alabama, United States
Legacy Good Samaritan Hospital & Comprehensive Cancer Center
🇺🇸Portland, Oregon, United States
CCOP - Columbia River Oncology Program
🇺🇸Portland, Oregon, United States
Providence Cancer Center at Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Providence St. Vincent Medical Center
🇺🇸Portland, Oregon, United States
Legacy Emanuel Hospital and Health Center and Children's Hospital
🇺🇸Portland, Oregon, United States
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Medical College of Wisconsin Cancer Center
🇺🇸Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee
🇺🇸Milwaukee, Wisconsin, United States
Mason District Hospital
🇺🇸Havana, Illinois, United States
Veterans Affairs Medical Center - Ann Arbor
🇺🇸Ann Arbor, Michigan, United States
Radiological Associates of Sacramento Medical Group, Incorporated
🇺🇸Sacramento, California, United States
Mercy General Hospital
🇺🇸Sacramento, California, United States
University of Michigan Comprehensive Cancer Center
🇺🇸Ann Arbor, Michigan, United States
Associates in Womens Health, PA - North Review
🇺🇸Wichita, Kansas, United States
Virginia G. Piper Cancer Center at Scottsdale Healthcare - Shea
🇺🇸Scottsdale, Arizona, United States
Kewanee Hospital
🇺🇸Kewanee, Illinois, United States
Illinois Valley Community Hospital
🇺🇸Peru, Illinois, United States
Radiation Oncology Center - Roseville
🇺🇸Roseville, California, United States
Valley Cancer Center
🇺🇸Spring Valley, Illinois, United States