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S0001 RT and Carmustine With or Without O6BG in Patients With New Glioblastoma Multiforme or Gliosarcoma

Primary Purpose

Malignant Neoplasms of Eye, Brain and Other Parts of Central Nervous System

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
carmustine
radiation therapy
O6-Benzylguanine
Sponsored by
SWOG Cancer Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Neoplasms of Eye, Brain and Other Parts of Central Nervous System focused on measuring adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed glioblastoma multiforme or gliosarcoma Biopsy or surgical resection within the past 28 days MRI* with gadolinium performed before registration Patients who undergo a simple biopsy only require preoperative MRI* with gadolinium No more than 2 noncontiguous tumor sites based on T2-weighted MRI (in 3 dimensions)* No prior radiotherapy-delivered cephalad to the interspace between the seventh cervical and the first thoracic vertebral body NOTE: *If an MRI is not medically feasible, patients may have a CT scan with contrast PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 3,000/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 8 g/dL Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) SGOT/SGPT no greater than 2 times ULN Alkaline phosphatase no greater than 2 times ULN PT/PTT no greater than 1.2 times ULN Renal: Not specified Cardiac: No severe cardiac disease, including any of the following: Uncontrolled arrhythmias or conduction defects Major problems with edema (e.g., residual swelling in the legs from deep vein thrombosis) Recent coronary artery disease Poorly controlled hypertension (i.e., diastolic blood pressure greater than 110 mm Hg and/or systolic blood pressure greater than 180 mm Hg) Pulmonary: DLCO at least 70% of predicted No severe pulmonary disease Other: HIV negative No severe Cushing's syndrome No known allergies to any of the study drugs No major psychiatric illness No poorly controlled diabetes complicated by steroid treatment No other medical illness that cannot be adequately controlled or that would preclude study participation No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy No other concurrent antitumor chemotherapy Endocrine therapy: No concurrent hormonal therapy except postmenopausal estrogen replacement therapy Corticosteroids at stable or decreasing dose for tumor edema allowed Radiotherapy: See Disease Characteristics No prior radiotherapy No other concurrent radiotherapy (including intensity-modulated radiotherapy) to the index lesion(s) Surgery: See Disease Characteristics No concurrent antitumor surgery Other: No other concurrent investigational drugs No other concurrent antineoplastic drugs or therapy

Sites / Locations

  • Alaska Regional Hospital Cancer Center
  • Banner Good Samaritan Medical Center
  • CCOP - Western Regional, Arizona
  • St. Joseph's Hospital and Medical Center
  • Banner Thunderbird Medical Center
  • North Bay Cancer Center
  • Memorial Hospital Cancer Center
  • St. Anthony Central Hospital
  • University of Colorado Cancer Center at University of Colorado Health Sciences Center
  • North Colorado Medical Center
  • McKee Medical Center
  • St. Anthony North Hospital
  • Exempla Lutheran Medical Center
  • West Florida Cancer Institute at West Florida Hospital - Pensacola
  • Piedmont Hospital
  • CCOP - Atlanta Regional
  • Northside Hospital Cancer Center
  • Saint Joseph's Hospital of Atlanta
  • WellStar Cobb Hospital
  • Charles B. Eberhart Cancer Center at DeKalb Medical Center
  • Northeast Georgia Medical Center
  • Gwinnett Medical Center
  • Kennestone Cancer Center at Wellstar Kennestone Hospital
  • Southern Regional Medical Center
  • Hematology Oncology Associates of Eastern Idaho
  • Saint Anthony's Hospital at Saint Anthony's Health Center
  • University of Illinois at Chicago Cancer Center
  • Veterans Affairs Medical Center - Chicago Westside Hospital
  • Decatur Memorial Hospital Cancer Care Institute
  • Good Samaritan Regional Health Center
  • Regional Cancer Center at Memorial Medical Center
  • St. Francis Hospital and Health Centers
  • Genesis Regional Cancer Center at Genesis Medical Center
  • Genesis Medical Center - West Campus
  • Cancer Center of Kansas - Chanute
  • Cancer Center of Kansas - Dodge City
  • Cancer Center of Kansas, P.A. - El Dorado
  • Veterans Affairs Medical Center - Kansas City
  • Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
  • Cancer Center of Kansas - Kingman
  • Southwest Medical Center
  • Cancer Center of Kansas - Newton
  • Cancer Center of Kansas, P.A. - Parsons
  • Pratt Cancer Center of Kansas
  • Cancer Center of Kansas - Salina
  • Salina Regional Health Center
  • Stormont-Vail Cancer Center
  • St. Francis Comprehensive Cancer Center
  • Cancer Center of Kansas - Wellington
  • Associates in Womens Health
  • Cancer Center of Kansas, P.A.
  • Cancer Center of Kansas, P.A. - Wichita
  • CCOP - Wichita
  • Via Christi Cancer Center at Via Christi Regional Medical Center
  • Wesley Medical Center
  • Cancer Center of Kansas - Winfield
  • Baton Rouge General Regional Cancer Center
  • Mary Bird Perkins Cancer Center - Baton Rouge
  • MBCCOP - LSU Health Sciences Center
  • Medical Center of Louisiana - New Orleans
  • Battle Creek Health System Cancer Care Center
  • Mecosta County General Hospital
  • CCOP - Grand Rapids
  • Lacks Cancer Center at Saint Mary's Mercy Medical Center
  • Spectrum Health Cancer Care - Butterworth Campus
  • Metropolitan Hospital
  • Holland Community Hospital
  • Hackley Hospital
  • Northern Michigan Hospital
  • William Beaumont Hospital - Royal Oak Campus
  • Munson Medical Center
  • University of Mississippi Medical Center
  • St. Francis Medical Center
  • Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
  • Freeman Cancer Institute at Freeman Health System
  • CCOP - Kansas City
  • St. John's Regional Health Center
  • Hulston Cancer Center at Cox Medical Center South
  • CCOP - St. Louis-Cape Girardeau
  • David C. Pratt Cancer Center at St. John's Mercy
  • CCOP - Montana Cancer Consortium
  • Deaconess Billings Clinic - Downtown
  • Hematology-Oncology Centers of the Northern Rockies - Billings
  • Northern Rockies Radiation Oncology Center
  • St. Vincent Healthcare
  • Deaconess Billings Clinic Cancer Center
  • Bozeman Deaconess Hospital
  • Internal Medicine Associates of Bozeman
  • St. James Community Hospital
  • Great Falls Clinic
  • Sletten Regional Cancer Institute
  • St. Peter's Hospital
  • Glacier Oncology, PLLC
  • Kalispell Medical Oncology
  • Eastern Montana Cancer Center
  • Community Medical Center
  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
  • Montana Cancer Specialists at Montana Cancer Center
  • Good Samaritan Health Systems
  • James P. Wilmot Cancer Center at University of Rochester Medical Center
  • Presbyterian Cancer Center at Presbyterian Hospital
  • Wayne Memorial Hospital, Incorporated
  • Adena Regional Medical Center
  • Cleveland Clinic Taussig Cancer Center
  • Riverside Methodist Hospital Cancer Care
  • CCOP - Columbus
  • Grant Riverside Cancer Services
  • Mount Carmel West Hospital
  • Doctors Hospital at Ohio Health
  • Grandview Hospital
  • Good Samaritan Hospital
  • David L. Rike Cancer Center at Miami Valley Hospital
  • Samaritan North Cancer Care Center
  • Veterans Affairs Medical Center - Dayton
  • CCOP - Dayton
  • Grady Memorial Hospital
  • Community Oncology Group - Independence
  • Charles F. Kettering Memorial Hospital
  • Fairfield Medical Center
  • Strecker Cancer Center at Marietta Memorial Hospital
  • Middletown Regional Hospital
  • Licking Memorial Cancer Care Program at Licking Memorial Hospital
  • Mercy Medical Center Oncology Unit
  • Community Hospital of Springfield and Clark County
  • UVMC Cancer Care Center at Upper Valley Medical Center
  • Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
  • Cleveland Clinic - Wooster
  • Ruth G. McMillan Cancer Center at Greene Memorial Hospital
  • Genesis - Good Samaritan Hospital
  • Legacy Mount Hood Medical Center
  • Providence Milwaukie Hospital
  • Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
  • Providence Cancer Center at Providence Portland Medical Center
  • CCOP - Columbia River Oncology Program
  • Providence St. Vincent Medical Center
  • Institute of Oncology at Vilnius University
  • Salem Hospital Regional Cancer Center
  • Legacy Meridian Park Hospital
  • Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
  • Brooke Army Medical Center
  • Wilford Hall Medical Center
  • CCOP - Scott and White Hospital
  • Huntsman Cancer Institute at University of Utah
  • Danville Regional Medical Center
  • St. Joseph Hospital Community Cancer Center
  • Olympic Hematology and Oncology
  • St. Francis Hospital
  • Skagit Valley Hospital Cancer Care Center
  • Capital Medical Center
  • Fred Hutchinson Cancer Research Center
  • Group Health Central Hospital
  • Harborview Medical Center
  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
  • University Cancer Center at University of Washington Medical Center
  • North Puget Oncology at United General Hospital
  • Cancer Care Northwest - Spokane South
  • Allenmore Hospital
  • CCOP - Northwest
  • St. Clare Hospital
  • Southwest Washington Medical Center Cancer Center
  • Central Washington Hospital
  • Wenatchee Valley Clinic
  • Welch Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

O6-BG + BCNU + Radiation Therapy

BCNU + Radiation Therapy

Arm Description

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: 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.

Outcomes

Primary Outcome Measures

Survival

Secondary Outcome Measures

Progression-free survival
Time to treatment failure
Toxicity

Full Information

First Posted
June 6, 2001
Last Updated
January 28, 2013
Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00017147
Brief Title
S0001 RT and Carmustine With or Without O6BG in Patients With New Glioblastoma Multiforme or Gliosarcoma
Official Title
A Phase III Study of Radiation Therapy (RT) and O6-Benzylguanine (O6-BG) Plus BCNU Versus RT and BCNU Alone for Newly Diagnosed Glioblastoma Multiforme (GBM) and Gliosarcoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Neoplasms of Eye, Brain and Other Parts of Central Nervous System
Keywords
adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
183 (Actual)

8. Arms, Groups, and Interventions

Arm Title
O6-BG + BCNU + Radiation Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
BCNU + Radiation Therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
carmustine
Intervention Description
40 mg/m^2 IV over 1 hour on day 1 of each cycle 6 hours after O6-BG dose for experimental arm with O6=BG. 200 mg/m^2 IV over 1 hour on day 2 of each cycle for the active comparator arm.
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
O6-Benzylguanine
Other Intervention Name(s)
O6-BG
Intervention Description
120 mg/m^2 IV over 1 hour on day 1 of each cycle
Primary Outcome Measure Information:
Title
Survival
Time Frame
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 Measure Information:
Title
Progression-free survival
Time Frame
assessed every 6 weeks for 42 weeks, then every 4 months for one year, followed by every 6 months for years 2 through 5
Title
Time to treatment failure
Time Frame
assessed every 6 weeks for 42 weeks, then every 4 months for one year, followed by every 6 months for years 2 through 5
Title
Toxicity
Time Frame
assessed weekly for 42 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed glioblastoma multiforme or gliosarcoma Biopsy or surgical resection within the past 28 days MRI* with gadolinium performed before registration Patients who undergo a simple biopsy only require preoperative MRI* with gadolinium No more than 2 noncontiguous tumor sites based on T2-weighted MRI (in 3 dimensions)* No prior radiotherapy-delivered cephalad to the interspace between the seventh cervical and the first thoracic vertebral body NOTE: *If an MRI is not medically feasible, patients may have a CT scan with contrast PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 3,000/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 8 g/dL Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) SGOT/SGPT no greater than 2 times ULN Alkaline phosphatase no greater than 2 times ULN PT/PTT no greater than 1.2 times ULN Renal: Not specified Cardiac: No severe cardiac disease, including any of the following: Uncontrolled arrhythmias or conduction defects Major problems with edema (e.g., residual swelling in the legs from deep vein thrombosis) Recent coronary artery disease Poorly controlled hypertension (i.e., diastolic blood pressure greater than 110 mm Hg and/or systolic blood pressure greater than 180 mm Hg) Pulmonary: DLCO at least 70% of predicted No severe pulmonary disease Other: HIV negative No severe Cushing's syndrome No known allergies to any of the study drugs No major psychiatric illness No poorly controlled diabetes complicated by steroid treatment No other medical illness that cannot be adequately controlled or that would preclude study participation No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy No other concurrent antitumor chemotherapy Endocrine therapy: No concurrent hormonal therapy except postmenopausal estrogen replacement therapy Corticosteroids at stable or decreasing dose for tumor edema allowed Radiotherapy: See Disease Characteristics No prior radiotherapy No other concurrent radiotherapy (including intensity-modulated radiotherapy) to the index lesion(s) Surgery: See Disease Characteristics No concurrent antitumor surgery Other: No other concurrent investigational drugs No other concurrent antineoplastic drugs or therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah T. Blumenthal, MD
Organizational Affiliation
University of Utah
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Alexander M. Spence, MD
Organizational Affiliation
University of Washington
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Keith J. Stelzer, MD, PhD
Organizational Affiliation
Celilo Cancer Center at Mid-Columbia Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Alaska Regional Hospital Cancer Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Banner Good Samaritan Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
CCOP - Western Regional, Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
St. Joseph's Hospital and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Banner Thunderbird Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
North Bay Cancer Center
City
Fairfield
State/Province
California
ZIP/Postal Code
94533
Country
United States
Facility Name
Memorial Hospital Cancer Center
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
St. Anthony Central Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
University of Colorado Cancer Center at University of Colorado Health Sciences Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80217-3364
Country
United States
Facility Name
North Colorado Medical Center
City
Greeley
State/Province
Colorado
ZIP/Postal Code
80631
Country
United States
Facility Name
McKee Medical Center
City
Loveland
State/Province
Colorado
ZIP/Postal Code
80539
Country
United States
Facility Name
St. Anthony North Hospital
City
Westminster
State/Province
Colorado
ZIP/Postal Code
80030
Country
United States
Facility Name
Exempla Lutheran Medical Center
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
West Florida Cancer Institute at West Florida Hospital - Pensacola
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32514
Country
United States
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
CCOP - Atlanta Regional
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Northside Hospital Cancer Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Saint Joseph's Hospital of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
WellStar Cobb Hospital
City
Austell
State/Province
Georgia
ZIP/Postal Code
30106
Country
United States
Facility Name
Charles B. Eberhart Cancer Center at DeKalb Medical Center
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Northeast Georgia Medical Center
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Gwinnett Medical Center
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30045
Country
United States
Facility Name
Kennestone Cancer Center at Wellstar Kennestone Hospital
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Southern Regional Medical Center
City
Riverdale
State/Province
Georgia
ZIP/Postal Code
30274
Country
United States
Facility Name
Hematology Oncology Associates of Eastern Idaho
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Saint Anthony's Hospital at Saint Anthony's Health Center
City
Alton
State/Province
Illinois
ZIP/Postal Code
62002
Country
United States
Facility Name
University of Illinois at Chicago Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Veterans Affairs Medical Center - Chicago Westside Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Decatur Memorial Hospital Cancer Care Institute
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Good Samaritan Regional Health Center
City
Mt. Vernon
State/Province
Illinois
ZIP/Postal Code
62864
Country
United States
Facility Name
Regional Cancer Center at Memorial Medical Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62781-0001
Country
United States
Facility Name
St. Francis Hospital and Health Centers
City
Beech Grove
State/Province
Indiana
ZIP/Postal Code
46107
Country
United States
Facility Name
Genesis Regional Cancer Center at Genesis Medical Center
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52803
Country
United States
Facility Name
Genesis Medical Center - West Campus
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52804
Country
United States
Facility Name
Cancer Center of Kansas - Chanute
City
Chanute
State/Province
Kansas
ZIP/Postal Code
66720
Country
United States
Facility Name
Cancer Center of Kansas - Dodge City
City
Dodge City
State/Province
Kansas
ZIP/Postal Code
67801
Country
United States
Facility Name
Cancer Center of Kansas, P.A. - El Dorado
City
El Dorado
State/Province
Kansas
ZIP/Postal Code
67042
Country
United States
Facility Name
Veterans Affairs Medical Center - Kansas City
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
64128
Country
United States
Facility Name
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Cancer Center of Kansas - Kingman
City
Kingman
State/Province
Kansas
ZIP/Postal Code
67068
Country
United States
Facility Name
Southwest Medical Center
City
Liberal
State/Province
Kansas
ZIP/Postal Code
67901
Country
United States
Facility Name
Cancer Center of Kansas - Newton
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Cancer Center of Kansas, P.A. - Parsons
City
Parsons
State/Province
Kansas
ZIP/Postal Code
67357
Country
United States
Facility Name
Pratt Cancer Center of Kansas
City
Pratt
State/Province
Kansas
ZIP/Postal Code
67124
Country
United States
Facility Name
Cancer Center of Kansas - Salina
City
Salina
State/Province
Kansas
ZIP/Postal Code
67042
Country
United States
Facility Name
Salina Regional Health Center
City
Salina
State/Province
Kansas
ZIP/Postal Code
67401
Country
United States
Facility Name
Stormont-Vail Cancer Center
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66604
Country
United States
Facility Name
St. Francis Comprehensive Cancer Center
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Cancer Center of Kansas - Wellington
City
Wellington
State/Province
Kansas
ZIP/Postal Code
67152
Country
United States
Facility Name
Associates in Womens Health
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67203
Country
United States
Facility Name
Cancer Center of Kansas, P.A.
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Cancer Center of Kansas, P.A. - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
CCOP - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Via Christi Cancer Center at Via Christi Regional Medical Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Wesley Medical Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Cancer Center of Kansas - Winfield
City
Winfield
State/Province
Kansas
ZIP/Postal Code
67156
Country
United States
Facility Name
Baton Rouge General Regional Cancer Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70806
Country
United States
Facility Name
Mary Bird Perkins Cancer Center - Baton Rouge
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
MBCCOP - LSU Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Medical Center of Louisiana - New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Battle Creek Health System Cancer Care Center
City
Battle Creek
State/Province
Michigan
ZIP/Postal Code
49017
Country
United States
Facility Name
Mecosta County General Hospital
City
Big Rapids
State/Province
Michigan
ZIP/Postal Code
49307
Country
United States
Facility Name
CCOP - Grand Rapids
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Lacks Cancer Center at Saint Mary's Mercy Medical Center
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Spectrum Health Cancer Care - Butterworth Campus
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Metropolitan Hospital
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49506
Country
United States
Facility Name
Holland Community Hospital
City
Holland
State/Province
Michigan
ZIP/Postal Code
49423
Country
United States
Facility Name
Hackley Hospital
City
Muskegon
State/Province
Michigan
ZIP/Postal Code
49443
Country
United States
Facility Name
Northern Michigan Hospital
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
Facility Name
William Beaumont Hospital - Royal Oak Campus
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Munson Medical Center
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
St. Francis Medical Center
City
Cape Girardeau
State/Province
Missouri
ZIP/Postal Code
63701
Country
United States
Facility Name
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
City
Gape Girardeau
State/Province
Missouri
ZIP/Postal Code
63701
Country
United States
Facility Name
Freeman Cancer Institute at Freeman Health System
City
Joplin
State/Province
Missouri
ZIP/Postal Code
64804
Country
United States
Facility Name
CCOP - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
St. John's Regional Health Center
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Hulston Cancer Center at Cox Medical Center South
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
CCOP - St. Louis-Cape Girardeau
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
David C. Pratt Cancer Center at St. John's Mercy
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
CCOP - Montana Cancer Consortium
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Deaconess Billings Clinic - Downtown
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Hematology-Oncology Centers of the Northern Rockies - Billings
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Northern Rockies Radiation Oncology Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
St. Vincent Healthcare
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Deaconess Billings Clinic Cancer Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59107
Country
United States
Facility Name
Bozeman Deaconess Hospital
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
Internal Medicine Associates of Bozeman
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
St. James Community Hospital
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Great Falls Clinic
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Sletten Regional Cancer Institute
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
St. Peter's Hospital
City
Helena
State/Province
Montana
ZIP/Postal Code
59601
Country
United States
Facility Name
Glacier Oncology, PLLC
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Kalispell Medical Oncology
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Eastern Montana Cancer Center
City
Miles City
State/Province
Montana
ZIP/Postal Code
59301
Country
United States
Facility Name
Community Medical Center
City
Missoula
State/Province
Montana
ZIP/Postal Code
59801
Country
United States
Facility Name
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
Montana Cancer Specialists at Montana Cancer Center
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
Good Samaritan Health Systems
City
Kearney
State/Province
Nebraska
ZIP/Postal Code
68847
Country
United States
Facility Name
James P. Wilmot Cancer Center at University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Presbyterian Cancer Center at Presbyterian Hospital
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28233
Country
United States
Facility Name
Wayne Memorial Hospital, Incorporated
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Adena Regional Medical Center
City
Chillicothe
State/Province
Ohio
ZIP/Postal Code
54601
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Riverside Methodist Hospital Cancer Care
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
CCOP - Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Grant Riverside Cancer Services
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Mount Carmel West Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43222
Country
United States
Facility Name
Doctors Hospital at Ohio Health
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43228
Country
United States
Facility Name
Grandview Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45405
Country
United States
Facility Name
Good Samaritan Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45406
Country
United States
Facility Name
David L. Rike Cancer Center at Miami Valley Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Samaritan North Cancer Care Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Facility Name
Veterans Affairs Medical Center - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45428
Country
United States
Facility Name
CCOP - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Grady Memorial Hospital
City
Delaware
State/Province
Ohio
ZIP/Postal Code
43015
Country
United States
Facility Name
Community Oncology Group - Independence
City
Independence
State/Province
Ohio
ZIP/Postal Code
44131
Country
United States
Facility Name
Charles F. Kettering Memorial Hospital
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Fairfield Medical Center
City
Lancaster
State/Province
Ohio
ZIP/Postal Code
43130
Country
United States
Facility Name
Strecker Cancer Center at Marietta Memorial Hospital
City
Marietta
State/Province
Ohio
ZIP/Postal Code
45750
Country
United States
Facility Name
Middletown Regional Hospital
City
Middletown
State/Province
Ohio
ZIP/Postal Code
45044
Country
United States
Facility Name
Licking Memorial Cancer Care Program at Licking Memorial Hospital
City
Newark
State/Province
Ohio
ZIP/Postal Code
43055
Country
United States
Facility Name
Mercy Medical Center Oncology Unit
City
Springfield
State/Province
Ohio
ZIP/Postal Code
45504
Country
United States
Facility Name
Community Hospital of Springfield and Clark County
City
Springfield
State/Province
Ohio
ZIP/Postal Code
45505
Country
United States
Facility Name
UVMC Cancer Care Center at Upper Valley Medical Center
City
Troy
State/Province
Ohio
ZIP/Postal Code
45373
Country
United States
Facility Name
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
City
Westerville
State/Province
Ohio
ZIP/Postal Code
43081
Country
United States
Facility Name
Cleveland Clinic - Wooster
City
Wooster
State/Province
Ohio
ZIP/Postal Code
44691
Country
United States
Facility Name
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
City
Xenia
State/Province
Ohio
ZIP/Postal Code
45385
Country
United States
Facility Name
Genesis - Good Samaritan Hospital
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
Facility Name
Legacy Mount Hood Medical Center
City
Glesham
State/Province
Oregon
ZIP/Postal Code
97030
Country
United States
Facility Name
Providence Milwaukie Hospital
City
Milwaukie
State/Province
Oregon
ZIP/Postal Code
97222
Country
United States
Facility Name
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Providence Cancer Center at Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
CCOP - Columbia River Oncology Program
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Providence St. Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Institute of Oncology at Vilnius University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Salem Hospital Regional Cancer Center
City
Salem
State/Province
Oregon
ZIP/Postal Code
97309
Country
United States
Facility Name
Legacy Meridian Park Hospital
City
Tualatin
State/Province
Oregon
ZIP/Postal Code
97062
Country
United States
Facility Name
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical Center
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Brooke Army Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
Wilford Hall Medical Center
City
Lackland AFB
State/Province
Texas
ZIP/Postal Code
78236
Country
United States
Facility Name
CCOP - Scott and White Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Huntsman Cancer Institute at University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Danville Regional Medical Center
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States
Facility Name
St. Joseph Hospital Community Cancer Center
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Olympic Hematology and Oncology
City
Bremerton
State/Province
Washington
ZIP/Postal Code
98310
Country
United States
Facility Name
St. Francis Hospital
City
Federal Way
State/Province
Washington
ZIP/Postal Code
98003
Country
United States
Facility Name
Skagit Valley Hospital Cancer Care Center
City
Mt. Vernon
State/Province
Washington
ZIP/Postal Code
98273
Country
United States
Facility Name
Capital Medical Center
City
Olympia
State/Province
Washington
ZIP/Postal Code
98507
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Group Health Central Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
City
Seattle
State/Province
Washington
ZIP/Postal Code
98114
Country
United States
Facility Name
University Cancer Center at University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
North Puget Oncology at United General Hospital
City
Sedro-Wooley
State/Province
Washington
ZIP/Postal Code
98284
Country
United States
Facility Name
Cancer Care Northwest - Spokane South
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Allenmore Hospital
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
CCOP - Northwest
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
St. Clare Hospital
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98499
Country
United States
Facility Name
Southwest Washington Medical Center Cancer Center
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98668
Country
United States
Facility Name
Central Washington Hospital
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
Wenatchee Valley Clinic
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
Welch Cancer Center
City
Sheridan
State/Province
Wyoming
ZIP/Postal Code
82801
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Blumenthal DT, Wade M, Rankin CJ, et al.: MGMT methylation in newly-diagnosed glioblastoma multiforme (GBM): from the S0001 phase III study of radiation therapy (RT) and O6-benzylguanine, (O6BG) plus BCNU versus RT and BCNU alone for newly diagnosed GBM. [Abstract] J Clin Oncol 24 (Suppl 18): A-1512, 2006.
Results Reference
result
PubMed Identifier
16033132
Citation
Quezado M, Ronchetti R, Rapkiewicz A, Santi M, Blumenthal DT, Rushing EJ. Chromogenic in situ hybridization accurately identifies EGFR amplification in small cell glioblastoma multiforme, a common subtype of primary GBM. Clin Neuropathol. 2005 Jul-Aug;24(4):163-9.
Results Reference
result
PubMed Identifier
25407559
Citation
Blumenthal DT, Rankin C, Stelzer KJ, Spence AM, Sloan AE, Moore DF Jr, Padula GD, Schulman SB, Wade ML, Rushing EJ. A Phase III study of radiation therapy (RT) and O(6)-benzylguanine + BCNU versus RT and BCNU alone and methylation status in newly diagnosed glioblastoma and gliosarcoma: Southwest Oncology Group (SWOG) study S0001. Int J Clin Oncol. 2015 Aug;20(4):650-8. doi: 10.1007/s10147-014-0769-0. Epub 2014 Nov 19.
Results Reference
derived

Learn more about this trial

S0001 RT and Carmustine With or Without O6BG in Patients With New Glioblastoma Multiforme or Gliosarcoma

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