S0001 RT and Carmustine With or Without O6BG in Patients With New Glioblastoma Multiforme or Gliosarcoma
- Conditions
- Malignant Neoplasms of Eye, Brain and Other Parts of Central Nervous System
- Interventions
- Registration Number
- NCT00017147
- Lead Sponsor
- SWOG Cancer Research Network
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. O6-benzylguanine may help carmustine kill more tumor cells by making tumor cells more sensitive to the drug. It is not yet known whether radiation therapy and carmustine are more effective with or without O6-benzylguanine.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus carmustine with or without O6-benzylguanine in treating patients who have newly diagnosed glioblastoma multiforme or gliosarcoma.
- Detailed Description
OBJECTIVES:
* Compare the overall survival, failure-free survival, and progression-free survival of patients with newly diagnosed glioblastoma multiforme or gliosarcoma treated with radiotherapy and carmustine with or without O6-benzylguanine.
* Compare the frequency and severity of toxic effects of these regimens in these patients.
* Correlate the survival of these patients with the expression of O6-alkylguanine-DNA alkyltransferase.
OUTLINE: This is a randomized study. Patients are stratified according to age (under 50 vs 50 and over), prior surgery (biopsy only vs resection), and Zubrod performance status (0-1 vs 2). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients undergo radiotherapy daily 5 days a week over 7 weeks for a total of 34 fractions. Patients also receive chemotherapy comprising O6-benzylguanine IV over 1 hour followed 6 hours later by carmustine IV over 1 hour on day 1 of radiotherapy. Chemotherapy repeats every 6 weeks for a maximum of 7 courses in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients undergo radiotherapy as in arm I. Patients receive carmustine IV as in arm I.
Patients are followed at week 48, every 4 months for 1 year, and then every 6 months for 4 years.
PROJECTED ACCRUAL: A total of 375 patients will be accrued for this study within 5 years.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 183
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description O6-BG + BCNU + Radiation Therapy radiation therapy O6-BG: 120 mg/m\^2 IV over 1 hour on day 1 of each cycle BCNU: 40 mg/m\^2 IV over 1 hour on day 1 of each cycle 6 hours after O6-BG dose. Radiation Therapy: 5 days/week using one fraction per day and a dose of 180 cGy per fraction. Initial target volume is dose of 5040 cGy in 28 fractions with boost target volume of 1080 cGy in 6 fractions. BCNU + Radiation Therapy radiation therapy BCNU: 40 mg/m\^2 IV over 1 hour on day 1 of each cycle. Radiation Therapy: 5 days/week using one fraction per day and a dose of 180 cGy per fraction. Initial target volume is dose of 5040 cGy in 28 fractions with boost target volume of 1080 cGy in 6 fractions. O6-BG + BCNU + Radiation Therapy carmustine O6-BG: 120 mg/m\^2 IV over 1 hour on day 1 of each cycle BCNU: 40 mg/m\^2 IV over 1 hour on day 1 of each cycle 6 hours after O6-BG dose. Radiation Therapy: 5 days/week using one fraction per day and a dose of 180 cGy per fraction. Initial target volume is dose of 5040 cGy in 28 fractions with boost target volume of 1080 cGy in 6 fractions. O6-BG + BCNU + Radiation Therapy O6-Benzylguanine O6-BG: 120 mg/m\^2 IV over 1 hour on day 1 of each cycle BCNU: 40 mg/m\^2 IV over 1 hour on day 1 of each cycle 6 hours after O6-BG dose. Radiation Therapy: 5 days/week using one fraction per day and a dose of 180 cGy per fraction. Initial target volume is dose of 5040 cGy in 28 fractions with boost target volume of 1080 cGy in 6 fractions. BCNU + Radiation Therapy carmustine BCNU: 40 mg/m\^2 IV over 1 hour on day 1 of each cycle. Radiation Therapy: 5 days/week using one fraction per day and a dose of 180 cGy per fraction. Initial target volume is dose of 5040 cGy in 28 fractions with boost target volume of 1080 cGy in 6 fractions.
- Primary Outcome Measures
Name Time Method Survival assessed every 6 weeks for 42 weeks, then every 4 months for one year, followed by every 6 months for years 2 through 5
- Secondary Outcome Measures
Name Time Method Time to treatment failure assessed every 6 weeks for 42 weeks, then every 4 months for one year, followed by every 6 months for years 2 through 5 Progression-free survival assessed every 6 weeks for 42 weeks, then every 4 months for one year, followed by every 6 months for years 2 through 5 Toxicity assessed weekly for 42 weeks
Trial Locations
- Locations (163)
Freeman Cancer Institute at Freeman Health System
🇺🇸Joplin, Missouri, United States
Great Falls Clinic
🇺🇸Great Falls, Montana, United States
Glacier Oncology, PLLC
🇺🇸Kalispell, Montana, United States
Licking Memorial Cancer Care Program at Licking Memorial Hospital
🇺🇸Newark, Ohio, United States
Wenatchee Valley Clinic
🇺🇸Wenatchee, Washington, United States
CCOP - Atlanta Regional
🇺🇸Atlanta, Georgia, United States
Northside Hospital Cancer Center
🇺🇸Atlanta, Georgia, United States
Saint Joseph's Hospital of Atlanta
🇺🇸Atlanta, Georgia, United States
Grant Riverside Cancer Services
🇺🇸Columbus, Ohio, United States
Doctors Hospital at Ohio Health
🇺🇸Columbus, Ohio, United States
Veterans Affairs Medical Center - Chicago Westside Hospital
🇺🇸Chicago, Illinois, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Group Health Central Hospital
🇺🇸Seattle, Washington, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
🇺🇸Seattle, Washington, United States
University Cancer Center at University of Washington Medical Center
🇺🇸Seattle, Washington, United States
West Florida Cancer Institute at West Florida Hospital - Pensacola
🇺🇸Pensacola, Florida, United States
WellStar Cobb Hospital
🇺🇸Austell, Georgia, United States
Piedmont Hospital
🇺🇸Atlanta, Georgia, United States
Alaska Regional Hospital Cancer Center
🇺🇸Anchorage, Alaska, United States
Kennestone Cancer Center at Wellstar Kennestone Hospital
🇺🇸Marietta, Georgia, United States
Hematology Oncology Associates of Eastern Idaho
🇺🇸Idaho Falls, Idaho, United States
Exempla Lutheran Medical Center
🇺🇸Wheat Ridge, Colorado, United States
St. Anthony North Hospital
🇺🇸Westminster, Colorado, United States
Charles B. Eberhart Cancer Center at DeKalb Medical Center
🇺🇸Decatur, Georgia, United States
Cancer Center of Kansas - Chanute
🇺🇸Chanute, Kansas, United States
North Colorado Medical Center
🇺🇸Greeley, Colorado, United States
Cancer Center of Kansas, P.A. - El Dorado
🇺🇸El Dorado, Kansas, United States
Veterans Affairs Medical Center - Kansas City
🇺🇸Kansas City, Kansas, United States
Memorial Hospital Cancer Center
🇺🇸Colorado Springs, Colorado, United States
Spectrum Health Cancer Care - Butterworth Campus
🇺🇸Grand Rapids, Michigan, United States
Cancer Center of Kansas - Dodge City
🇺🇸Dodge City, Kansas, United States
Battle Creek Health System Cancer Care Center
🇺🇸Battle Creek, Michigan, United States
Saint Anthony's Hospital at Saint Anthony's Health Center
🇺🇸Alton, Illinois, United States
Baton Rouge General Regional Cancer Center
🇺🇸Baton Rouge, Louisiana, United States
Decatur Memorial Hospital Cancer Care Institute
🇺🇸Decatur, Illinois, United States
Cancer Center of Kansas, P.A. - Parsons
🇺🇸Parsons, Kansas, United States
Cancer Center of Kansas - Kingman
🇺🇸Kingman, Kansas, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
CCOP - Grand Rapids
🇺🇸Grand Rapids, Michigan, United States
Lacks Cancer Center at Saint Mary's Mercy Medical Center
🇺🇸Grand Rapids, Michigan, United States
Southern Regional Medical Center
🇺🇸Riverdale, Georgia, United States
Mary Bird Perkins Cancer Center - Baton Rouge
🇺🇸Baton Rouge, Louisiana, United States
Gwinnett Medical Center
🇺🇸Lawrenceville, Georgia, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
🇺🇸Billings, Montana, United States
Wesley Medical Center
🇺🇸Wichita, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Hulston Cancer Center at Cox Medical Center South
🇺🇸Springfield, Missouri, United States
St. Francis Hospital and Health Centers
🇺🇸Beech Grove, Indiana, United States
Hackley Hospital
🇺🇸Muskegon, Michigan, United States
Holland Community Hospital
🇺🇸Holland, Michigan, United States
CCOP - Columbus
🇺🇸Columbus, Ohio, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
St. Francis Medical Center
🇺🇸Cape Girardeau, Missouri, United States
CCOP - St. Louis-Cape Girardeau
🇺🇸St. Louis, Missouri, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
🇺🇸Missoula, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
🇺🇸Missoula, Montana, United States
CCOP - Kansas City
🇺🇸Kansas City, Missouri, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Mecosta County General Hospital
🇺🇸Big Rapids, Michigan, United States
Metropolitan Hospital
🇺🇸Grand Rapids, Michigan, United States
Cancer Center of Kansas - Winfield
🇺🇸Winfield, Kansas, United States
William Beaumont Hospital - Royal Oak Campus
🇺🇸Royal Oak, Michigan, United States
St. Peter's Hospital
🇺🇸Helena, Montana, United States
St. James Community Hospital
🇺🇸Butte, Montana, United States
Brooke Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States
Grady Memorial Hospital
🇺🇸Delaware, Ohio, United States
Mercy Medical Center Oncology Unit
🇺🇸Springfield, Ohio, United States
Genesis - Good Samaritan Hospital
🇺🇸Zanesville, Ohio, United States
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
🇺🇸Kingsport, Tennessee, United States
Legacy Meridian Park Hospital
🇺🇸Tualatin, Oregon, United States
St. Joseph Hospital Community Cancer Center
🇺🇸Bellingham, Washington, United States
Welch Cancer Center
🇺🇸Sheridan, Wyoming, United States
Huntsman Cancer Institute at University of Utah
🇺🇸Salt Lake City, Utah, United States
Deaconess Billings Clinic Cancer Center
🇺🇸Billings, Montana, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Kalispell Medical Oncology
🇺🇸Kalispell, Montana, United States
Bozeman Deaconess Hospital
🇺🇸Bozeman, Montana, United States
Sletten Regional Cancer Institute
🇺🇸Great Falls, Montana, United States
Banner Good Samaritan Medical Center
🇺🇸Phoenix, Arizona, United States
CCOP - Western Regional, Arizona
🇺🇸Phoenix, Arizona, United States
St. Joseph's Hospital and Medical Center
🇺🇸Phoenix, Arizona, United States
Banner Thunderbird Medical Center
🇺🇸Phoenix, Arizona, United States
St. Anthony Central Hospital
🇺🇸Denver, Colorado, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
🇺🇸Denver, Colorado, United States
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
🇺🇸Portland, Oregon, United States
Providence Cancer Center at Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
CCOP - Columbia River Oncology Program
🇺🇸Portland, Oregon, United States
Institute of Oncology at Vilnius University
🇺🇸Portland, Oregon, United States
Providence St. Vincent Medical Center
🇺🇸Portland, Oregon, United States
Wilford Hall Medical Center
🇺🇸Lackland AFB, Texas, United States
North Bay Cancer Center
🇺🇸Fairfield, California, United States
McKee Medical Center
🇺🇸Loveland, Colorado, United States
University of Illinois at Chicago Cancer Center
🇺🇸Chicago, Illinois, United States
Northeast Georgia Medical Center
🇺🇸Gainesville, Georgia, United States
Regional Cancer Center at Memorial Medical Center
🇺🇸Springfield, Illinois, United States
Good Samaritan Regional Health Center
🇺🇸Mt. Vernon, Illinois, United States
Genesis Regional Cancer Center at Genesis Medical Center
🇺🇸Davenport, Iowa, United States
Genesis Medical Center - West Campus
🇺🇸Davenport, Iowa, United States
Cancer Center of Kansas - Newton
🇺🇸Newton, Kansas, United States
Southwest Medical Center
🇺🇸Liberal, Kansas, United States
Salina Regional Health Center
🇺🇸Salina, Kansas, United States
St. Francis Comprehensive Cancer Center
🇺🇸Topeka, Kansas, United States
Pratt Cancer Center of Kansas
🇺🇸Pratt, Kansas, United States
Stormont-Vail Cancer Center
🇺🇸Topeka, Kansas, United States
Cancer Center of Kansas - Salina
🇺🇸Salina, Kansas, United States
Associates in Womens Health
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, P.A.
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas - Wellington
🇺🇸Wellington, Kansas, United States
Cancer Center of Kansas, P.A. - Wichita
🇺🇸Wichita, Kansas, United States
MBCCOP - LSU Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Medical Center of Louisiana - New Orleans
🇺🇸New Orleans, Louisiana, United States
Munson Medical Center
🇺🇸Traverse City, Michigan, United States
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
🇺🇸Gape Girardeau, Missouri, United States
Deaconess Billings Clinic - Downtown
🇺🇸Billings, Montana, United States
St. John's Regional Health Center
🇺🇸Springfield, Missouri, United States
St. Vincent Healthcare
🇺🇸Billings, Montana, United States
David C. Pratt Cancer Center at St. John's Mercy
🇺🇸St. Louis, Missouri, United States
Northern Rockies Radiation Oncology Center
🇺🇸Billings, Montana, United States
Eastern Montana Cancer Center
🇺🇸Miles City, Montana, United States
Community Medical Center
🇺🇸Missoula, Montana, United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
🇺🇸Rochester, New York, United States
Good Samaritan Health Systems
🇺🇸Kearney, Nebraska, United States
Presbyterian Cancer Center at Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States
Wayne Memorial Hospital, Incorporated
🇺🇸Goldsboro, North Carolina, United States
Cleveland Clinic Taussig Cancer Center
🇺🇸Cleveland, Ohio, United States
Adena Regional Medical Center
🇺🇸Chillicothe, Ohio, United States
Riverside Methodist Hospital Cancer Care
🇺🇸Columbus, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
Grandview Hospital
🇺🇸Dayton, Ohio, United States
Mount Carmel West Hospital
🇺🇸Columbus, Ohio, United States
Good Samaritan Hospital
🇺🇸Dayton, Ohio, United States
Samaritan North Cancer Care Center
🇺🇸Dayton, Ohio, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
Veterans Affairs Medical Center - Dayton
🇺🇸Dayton, Ohio, United States
Middletown Regional Hospital
🇺🇸Middletown, Ohio, United States
Charles F. Kettering Memorial Hospital
🇺🇸Kettering, Ohio, United States
Strecker Cancer Center at Marietta Memorial Hospital
🇺🇸Marietta, Ohio, United States
Community Oncology Group - Independence
🇺🇸Independence, Ohio, United States
Fairfield Medical Center
🇺🇸Lancaster, Ohio, United States
Community Hospital of Springfield and Clark County
🇺🇸Springfield, Ohio, United States
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
🇺🇸Westerville, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center
🇺🇸Troy, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
🇺🇸Xenia, Ohio, United States
Cleveland Clinic - Wooster
🇺🇸Wooster, Ohio, United States
Providence Milwaukie Hospital
🇺🇸Milwaukie, Oregon, United States
Legacy Mount Hood Medical Center
🇺🇸Glesham, Oregon, United States
Salem Hospital Regional Cancer Center
🇺🇸Salem, Oregon, United States
Olympic Hematology and Oncology
🇺🇸Bremerton, Washington, United States
CCOP - Scott and White Hospital
🇺🇸Temple, Texas, United States
St. Francis Hospital
🇺🇸Federal Way, Washington, United States
Danville Regional Medical Center
🇺🇸Danville, Virginia, United States
Skagit Valley Hospital Cancer Care Center
🇺🇸Mt. Vernon, Washington, United States
Capital Medical Center
🇺🇸Olympia, Washington, United States
North Puget Oncology at United General Hospital
🇺🇸Sedro-Wooley, Washington, United States
Cancer Care Northwest - Spokane South
🇺🇸Spokane, Washington, United States
Allenmore Hospital
🇺🇸Tacoma, Washington, United States
CCOP - Northwest
🇺🇸Tacoma, Washington, United States
St. Clare Hospital
🇺🇸Tacoma, Washington, United States
Southwest Washington Medical Center Cancer Center
🇺🇸Vancouver, Washington, United States
Central Washington Hospital
🇺🇸Wenatchee, Washington, United States
Internal Medicine Associates of Bozeman
🇺🇸Bozeman, Montana, United States
Northern Michigan Hospital
🇺🇸Petoskey, Michigan, United States