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Radiation Therapy With or Without Chemotherapy in Treating Patients With Anaplastic Oligodendroglioma

Primary Purpose

Brain and Central Nervous System Tumors

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
lomustine
procarbazine hydrochloride
vincristine sulfate
radiation therapy
Sponsored by
Radiation Therapy Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult anaplastic oligodendroglioma, adult mixed glioma

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically proven unifocal or multifocal, supratentorial, pure or mixed anaplastic oligodendroglioma Prior suspected or proven low-grade glioma allowed if current histologic proof of pure or mixed anaplastic oligodendroglioma Tumor must contain an unequivocal (at least 25%) oligodendroglial element and have 2 or more anaplastic features, 1 of which must be frequent mitoses or endothelial proliferation For mixed tumors, the non-oligodendroglial element must be astrocytic and the oligodendroglial or astroglial component may be anaplastic No evidence of spinal drop metastasis or spread to noncontiguous meninges MRI of spine not required for asymptomatic patients and patients not excluded based on pathologic evidence of local meningeal infiltration by underlying tumor No tumor that is predominantly located in the posterior fossa (i.e., brainstem or cerebellum) No spinal cord tumors PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 150,000/mm^3 Hepatic: Bilirubin no greater than 2 times normal Serum glutamate oxaloacetate transaminase (SGOT) no greater than 2 times normal Alkaline phosphatase no greater than 2 times normal Renal: Creatinine no greater than 1.5 times normal Pulmonary: No chronic lung disease unless diffusion capacity of lung for carbon monoxide (DLCO) is at least 60% predicted Other: No active infection No other malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: No concurrent steroids as antiemetics Concurrent steroids allowed to control central nervous system (CNS) symptoms due to tumor-associated or radiotherapy-associated cerebral edema Radiotherapy: No prior radiotherapy to brain or head/neck Surgery: Prior surgery allowed

Sites / Locations

  • MBCCOP - Gulf Coast
  • CCOP - Greater Phoenix
  • Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
  • Veterans Affairs Medical Center - Tucson
  • Arizona Cancer Center
  • University of Arkansas for Medical Sciences
  • Veterans Affairs Medical Center - Little Rock (McClellan)
  • Cancer Center and Beckman Research Institute, City of Hope
  • USC/Norris Comprehensive Cancer Center and Hospital
  • Veterans Affairs Medical Center - West Los Angeles
  • Jonsson Comprehensive Cancer Center, UCLA
  • Veterans Affairs Outpatient Clinic - Martinez
  • CCOP - Bay Area Tumor Institute
  • Chao Family Comprehensive Cancer Center
  • University of California Davis Medical Center
  • UCSF Cancer Center and Cancer Research Institute
  • CCOP - Santa Rosa Memorial Hospital
  • David Grant Medical Center
  • University of Colorado Cancer Center
  • Veterans Affairs Medical Center - Denver
  • CCOP - Atlanta Regional
  • Dwight David Eisenhower Army Medical Center
  • Cancer Research Center of Hawaii
  • Tripler Army Medical Center
  • MBCCOP - University of Illinois at Chicago
  • Veterans Affairs Medical Center - Chicago (Westside Hospital)
  • CCOP - Central Illinois
  • Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
  • Loyola University Medical Center
  • University of Kansas Medical Center
  • CCOP - Wichita
  • Veterans Affairs Medical Center - Wichita
  • Veterans Affairs Medical Center - Lexington
  • Albert B. Chandler Medical Center, University of Kentucky
  • MBCCOP - LSU Health Sciences Center
  • Tulane University School of Medicine
  • Louisiana State University Health Sciences Center - Shreveport
  • Veterans Affairs Medical Center - Shreveport
  • Boston Medical Center
  • Veterans Affairs Medical Center - Boston (Jamaica Plain)
  • Veterans Affairs Medical Center - Ann Arbor
  • CCOP - Ann Arbor Regional
  • University of Michigan Comprehensive Cancer Center
  • Barbara Ann Karmanos Cancer Institute
  • Veterans Affairs Medical Center - Detroit
  • Henry Ford Hospital
  • Providence Hospital - Southfield
  • CCOP - Duluth
  • Veterans Affairs Medical Center - Biloxi
  • University of Mississippi Medical Center
  • Veterans Affairs Medical Center - Jackson
  • Keesler Medical Center - Keesler AFB
  • Veterans Affairs Medical Center - Kansas City
  • CCOP - Kansas City
  • St. Louis University Health Sciences Center
  • CCOP - St. Louis-Cape Girardeau
  • CCOP - Cancer Research for the Ozarks
  • CCOP - Montana Cancer Consortium
  • Veterans Affairs Medical Center - Albuquerque
  • MBCCOP - University of New Mexico HSC
  • Veterans Affairs Medical Center - Albany
  • Herbert Irving Comprehensive Cancer Center
  • University of Rochester Medical Center
  • CCOP - Southeast Cancer Control Consortium
  • Veterans Affairs Medical Center - Cincinnati
  • Barrett Cancer Center, The University Hospital
  • Cleveland Clinic Taussig Cancer Center
  • CCOP - Columbus
  • Veterans Affairs Medical Center - Dayton
  • CCOP - Dayton
  • CCOP - Toledo Community Hospital Oncology Program
  • Oklahoma Medical Research Foundation
  • Veterans Affairs Medical Center - Oklahoma City
  • Veterans Affairs Medical Center - Portland
  • CCOP - Columbia River Program
  • OHSU Cancer Institute
  • Veterans Affairs Medical Center - Charleston
  • Medical University of South Carolina
  • CCOP - Greenville
  • CCOP - Upstate Carolina
  • Brooke Army Medical Center
  • University of Texas Medical Branch
  • Veterans Affairs Medical Center - Houston
  • Texas Tech University Health Science Center
  • University of Texas Health Science Center at San Antonio
  • Veterans Affairs Medical Center - San Antonio (Murphy)
  • Veterans Affairs Medical Center - Temple
  • CCOP - Scott and White Hospital
  • Huntsman Cancer Institute
  • Veterans Affairs Medical Center - Salt Lake City
  • CCOP - Virginia Mason Research Center
  • Swedish Cancer Institute
  • Veterans Affairs Medical Center - Seattle
  • CCOP - Northwest
  • Madigan Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Radiation therapy (RT) alone

Intensive pre-treatment chemotherapy and radiation therapy

Arm Description

Radiation therapy (RT) alone - External Beam RT 59.4 Gy (1.8 Gy x 33 fractions, 5 days a week) to MR defined tumor volume.

Intensive pre-treatment chemotherapy (Day 1 CCNU 130 mg/m2 p.o., Day 8 - Vincristine 1.4 mg/m2 i.v., Days 8-21 - Procarbazine 75 mg/m2 p.o., Day 29 - Vincristine 1.4 mg/m2 i.v.) followed by radiation therapy (External Beam RT 59.4 Gy (1.8 Gy x 33 fractions, 5 days a week) to MR defined tumor volume).

Outcomes

Primary Outcome Measures

Overall Survival

Secondary Outcome Measures

Time to tumor progression
Frequency of severe (>= Grade 3) toxicities

Full Information

First Posted
November 1, 1999
Last Updated
June 15, 2018
Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI), North Central Cancer Treatment Group, SWOG Cancer Research Network, Eastern Cooperative Oncology Group, NCIC Clinical Trials Group
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1. Study Identification

Unique Protocol Identification Number
NCT00002569
Brief Title
Radiation Therapy With or Without Chemotherapy in Treating Patients With Anaplastic Oligodendroglioma
Official Title
Phase III Intergroup Randomized Comparison of Radiation Alone vs. Pre-Radiation Chemotherapy for Pure and Mixed Anaplastic Oligodendrogliomas
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
July 1994 (Actual)
Primary Completion Date
February 2005 (Actual)
Study Completion Date
May 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI), North Central Cancer Treatment Group, SWOG Cancer Research Network, Eastern Cooperative Oncology Group, NCIC Clinical Trials Group

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. Combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without chemotherapy in treating patients who have anaplastic oligodendroglioma.
Detailed Description
OBJECTIVES: Compare the overall survival and time to tumor progression in patients with unifocal or multifocal, supratentorial, pure or mixed anaplastic oligodendroglioma treated with radiotherapy with or without procarbazine, lomustine, and vincristine (PCV). Compare the toxic effects of these 2 regimens in these patients. Compare the quality of life and neurologic function of patients treated with these 2 regimens. OUTLINE: This is a randomized study. Patients are stratified by age (under 50 vs 50 and over), Karnofsky performance status (60-70% vs 80-100%), and tumor grade (moderately vs highly anaplastic). Within 8 weeks after diagnostic surgery, patients are randomized to 1 of 2 treatment arms. Arm I: Within 2 weeks after randomization, patients receive oral lomustine on day 1, oral procarbazine on days 8-21, and vincristine IV on days 8 and 29 (PCV). Treatment continues every 6 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning within 6 weeks after day 29 of course 4, patients undergo radiotherapy 5 days a week for 5.6 weeks followed by boost radiotherapy 5 days a week for 1 week. Arm II: Within 2 weeks after randomization, patients undergo radiotherapy as in arm I. Quality of life is assessed at baseline; at time of CT or MRI scans during study; and every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter after completion of study therapy. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 292 patients (146 per arm) will be accrued for this study within 5.4 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain and Central Nervous System Tumors
Keywords
adult anaplastic oligodendroglioma, adult mixed glioma

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Radiation therapy (RT) alone
Arm Type
Active Comparator
Arm Description
Radiation therapy (RT) alone - External Beam RT 59.4 Gy (1.8 Gy x 33 fractions, 5 days a week) to MR defined tumor volume.
Arm Title
Intensive pre-treatment chemotherapy and radiation therapy
Arm Type
Experimental
Arm Description
Intensive pre-treatment chemotherapy (Day 1 CCNU 130 mg/m2 p.o., Day 8 - Vincristine 1.4 mg/m2 i.v., Days 8-21 - Procarbazine 75 mg/m2 p.o., Day 29 - Vincristine 1.4 mg/m2 i.v.) followed by radiation therapy (External Beam RT 59.4 Gy (1.8 Gy x 33 fractions, 5 days a week) to MR defined tumor volume).
Intervention Type
Drug
Intervention Name(s)
lomustine
Intervention Type
Drug
Intervention Name(s)
procarbazine hydrochloride
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Overall Survival
Time Frame
From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years.
Secondary Outcome Measure Information:
Title
Time to tumor progression
Time Frame
From randomization to date of progression or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years.
Title
Frequency of severe (>= Grade 3) toxicities
Time Frame
From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 3 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically proven unifocal or multifocal, supratentorial, pure or mixed anaplastic oligodendroglioma Prior suspected or proven low-grade glioma allowed if current histologic proof of pure or mixed anaplastic oligodendroglioma Tumor must contain an unequivocal (at least 25%) oligodendroglial element and have 2 or more anaplastic features, 1 of which must be frequent mitoses or endothelial proliferation For mixed tumors, the non-oligodendroglial element must be astrocytic and the oligodendroglial or astroglial component may be anaplastic No evidence of spinal drop metastasis or spread to noncontiguous meninges MRI of spine not required for asymptomatic patients and patients not excluded based on pathologic evidence of local meningeal infiltration by underlying tumor No tumor that is predominantly located in the posterior fossa (i.e., brainstem or cerebellum) No spinal cord tumors PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 150,000/mm^3 Hepatic: Bilirubin no greater than 2 times normal Serum glutamate oxaloacetate transaminase (SGOT) no greater than 2 times normal Alkaline phosphatase no greater than 2 times normal Renal: Creatinine no greater than 1.5 times normal Pulmonary: No chronic lung disease unless diffusion capacity of lung for carbon monoxide (DLCO) is at least 60% predicted Other: No active infection No other malignancy within the past 5 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: No concurrent steroids as antiemetics Concurrent steroids allowed to control central nervous system (CNS) symptoms due to tumor-associated or radiotherapy-associated cerebral edema Radiotherapy: No prior radiotherapy to brain or head/neck Surgery: Prior surgery allowed
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. Gregory Cairncross, MD
Organizational Affiliation
London Health Sciences Centre
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Steven R. Alberts, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Karen L. Fink, MD, PhD
Organizational Affiliation
Simmons Cancer Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Richard M. Hellman, MD
Organizational Affiliation
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Normand Laperriere, MD, FRCPC
Organizational Affiliation
Princess Margaret Hospital, Canada
Official's Role
Study Chair
Facility Information:
Facility Name
MBCCOP - Gulf Coast
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36688
Country
United States
Facility Name
CCOP - Greater Phoenix
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006-2726
Country
United States
Facility Name
Veterans Affairs Medical Center - Phoenix (Carl T. Hayden)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Veterans Affairs Medical Center - Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Facility Name
Arizona Cancer Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Veterans Affairs Medical Center - Little Rock (McClellan)
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Cancer Center and Beckman Research Institute, City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center and Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033-0804
Country
United States
Facility Name
Veterans Affairs Medical Center - West Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
Veterans Affairs Outpatient Clinic - Martinez
City
Martinez
State/Province
California
ZIP/Postal Code
94553
Country
United States
Facility Name
CCOP - Bay Area Tumor Institute
City
Oakland
State/Province
California
ZIP/Postal Code
94609-3305
Country
United States
Facility Name
Chao Family Comprehensive Cancer Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
University of California Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
UCSF Cancer Center and Cancer Research Institute
City
San Francisco
State/Province
California
ZIP/Postal Code
94143-0128
Country
United States
Facility Name
CCOP - Santa Rosa Memorial Hospital
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
David Grant Medical Center
City
Travis Air Force Base
State/Province
California
ZIP/Postal Code
94535
Country
United States
Facility Name
University of Colorado Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80010
Country
United States
Facility Name
Veterans Affairs Medical Center - Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
CCOP - Atlanta Regional
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342-1701
Country
United States
Facility Name
Dwight David Eisenhower Army Medical Center
City
Fort Gordon
State/Province
Georgia
ZIP/Postal Code
30905-5650
Country
United States
Facility Name
Cancer Research Center of Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813-2424
Country
United States
Facility Name
Tripler Army Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96859-5000
Country
United States
Facility Name
MBCCOP - University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-7323
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
CCOP - Central Illinois
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
City
Hines
State/Province
Illinois
ZIP/Postal Code
60141
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-7353
Country
United States
Facility Name
CCOP - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214-3882
Country
United States
Facility Name
Veterans Affairs Medical Center - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67218
Country
United States
Facility Name
Veterans Affairs Medical Center - Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40502-2236
Country
United States
Facility Name
Albert B. Chandler Medical Center, University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0084
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
Tulane University School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Louisiana State University Health Sciences Center - Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130-3932
Country
United States
Facility Name
Veterans Affairs Medical Center - Shreveport
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71130
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Veterans Affairs Medical Center - Boston (Jamaica Plain)
City
Jamaica Plain
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
Facility Name
Veterans Affairs Medical Center - Ann Arbor
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
CCOP - Ann Arbor Regional
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0912
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States
Facility Name
Veterans Affairs Medical Center - Detroit
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1932
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Providence Hospital - Southfield
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075-9975
Country
United States
Facility Name
CCOP - Duluth
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Veterans Affairs Medical Center - Biloxi
City
Biloxi
State/Province
Mississippi
ZIP/Postal Code
39531-2410
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216-4505
Country
United States
Facility Name
Veterans Affairs Medical Center - Jackson
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Keesler Medical Center - Keesler AFB
City
Keesler Air Force Base
State/Province
Mississippi
ZIP/Postal Code
39534-2576
Country
United States
Facility Name
Veterans Affairs Medical Center - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
Facility Name
CCOP - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
St. Louis University Health Sciences Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
CCOP - St. Louis-Cape Girardeau
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
CCOP - Cancer Research for the Ozarks
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
CCOP - Montana Cancer Consortium
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Veterans Affairs Medical Center - Albuquerque
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108-5138
Country
United States
Facility Name
MBCCOP - University of New Mexico HSC
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Facility Name
Veterans Affairs Medical Center - Albany
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Herbert Irving Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
CCOP - Southeast Cancer Control Consortium
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27104-4241
Country
United States
Facility Name
Veterans Affairs Medical Center - Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220-2288
Country
United States
Facility Name
Barrett Cancer Center, The University Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0501
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
CCOP - Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43206
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
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
CCOP - Toledo Community Hospital Oncology Program
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623-3456
Country
United States
Facility Name
Oklahoma Medical Research Foundation
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Veterans Affairs Medical Center - Oklahoma City
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Veterans Affairs Medical Center - Portland
City
Portland
State/Province
Oregon
ZIP/Postal Code
97207
Country
United States
Facility Name
CCOP - Columbia River Program
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
OHSU Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Veterans Affairs Medical Center - Charleston
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401-5799
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425-0721
Country
United States
Facility Name
CCOP - Greenville
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
CCOP - Upstate Carolina
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Brooke Army Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234-6200
Country
United States
Facility Name
University of Texas Medical Branch
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0565
Country
United States
Facility Name
Veterans Affairs Medical Center - Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Tech University Health Science Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79415
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284-7845
Country
United States
Facility Name
Veterans Affairs Medical Center - San Antonio (Murphy)
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78284
Country
United States
Facility Name
Veterans Affairs Medical Center - Temple
City
Temple
State/Province
Texas
ZIP/Postal Code
76504
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
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112-5550
Country
United States
Facility Name
Veterans Affairs Medical Center - Salt Lake City
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84148
Country
United States
Facility Name
CCOP - Virginia Mason Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Swedish Cancer Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Veterans Affairs Medical Center - Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Facility Name
CCOP - Northwest
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405-0986
Country
United States
Facility Name
Madigan Army Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431-5048
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Cairncross JG, Wang M, Shaw EG, et al.: Chemotherapy plus radiotherapy (CT-RT) versus RT alone for patients with anaplastic oligodendroglioma: long-term results of the RTOG 9402 phase III study. [Abstract] J Clin Oncol 30 (Suppl 15): A-2008b, 2012.
Results Reference
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PubMed Identifier
19783377
Citation
Wang M, Cairncross G, Shaw E, Jenkins R, Scheithauer B, Brachman D, Buckner J, Fink K, Souhami L, Laperriere N, Mehta M, Curran W; Radiation Therapy Oncology Group (RTOG); North Central Cancer Treatment Group (NCCTG); Southwest Oncology Group (SWOG); National Cancer Institute of Canada Clinical Trials Group (NCIC CTG); Eastern Cooperative Oncology Group (ECOG). Cognition and quality of life after chemotherapy plus radiotherapy (RT) vs. RT for pure and mixed anaplastic oligodendrogliomas: radiation therapy oncology group trial 9402. Int J Radiat Oncol Biol Phys. 2010 Jul 1;77(3):662-9. doi: 10.1016/j.ijrobp.2009.06.004. Epub 2009 Sep 23.
Results Reference
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PubMed Identifier
18371182
Citation
Giannini C, Burger PC, Berkey BA, Cairncross JG, Jenkins RB, Mehta M, Curran WJ, Aldape K. Anaplastic oligodendroglial tumors: refining the correlation among histopathology, 1p 19q deletion and clinical outcome in Intergroup Radiation Therapy Oncology Group Trial 9402. Brain Pathol. 2008 Jul;18(3):360-9. doi: 10.1111/j.1750-3639.2008.00129.x. Epub 2008 Mar 26.
Results Reference
result
PubMed Identifier
16782910
Citation
Intergroup Radiation Therapy Oncology Group Trial 9402; Cairncross G, Berkey B, Shaw E, Jenkins R, Scheithauer B, Brachman D, Buckner J, Fink K, Souhami L, Laperierre N, Mehta M, Curran W. Phase III trial of chemotherapy plus radiotherapy compared with radiotherapy alone for pure and mixed anaplastic oligodendroglioma: Intergroup Radiation Therapy Oncology Group Trial 9402. J Clin Oncol. 2006 Jun 20;24(18):2707-14. doi: 10.1200/JCO.2005.04.3414.
Results Reference
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Citation
Cairncross G, Seiferheld W, Shaw E, et al.: An intergroup randomized controlled clinical trial (RCT) of chemotherapy plus radiation (RT) versus RT alone for pure and mixed anaplastic oligodendrogliomas: initial report of RTOG 94-02. [Abstract] J Clin Oncol 22 (Suppl 14): A-1500, 107s, 2004.
Results Reference
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Citation
Shaw EG, Seiferheld W, Cairncross JG, et al.: Radiation therapy (RT) alone vs intensive procarbazine-CCNU-vincristine (I-PCV) chemotherapy followed by radiation therapy for anaplastic oligodendroglioma (AO) and mixed oligo-astrocytoma (MOA): results of Radiation Therapy Oncology Group (RTOG) - intergroup protocol 94-02. [Abstract] Int J Radiat Oncol Biol Phys 60 (1 Suppl 1): A-57, S163, 2004.
Results Reference
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PubMed Identifier
11586105
Citation
Jenkins RB, Curran W, Scott CB, Cairncross G. Pilot evaluation of 1p and 19q deletions in anaplastic oligodendrogliomas collected by a national cooperative cancer treatment group. Am J Clin Oncol. 2001 Oct;24(5):506-8. doi: 10.1097/00000421-200110000-00018.
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PubMed Identifier
35731991
Citation
Lassman AB, Hoang-Xuan K, Polley MC, Brandes AA, Cairncross JG, Kros JM, Ashby LS, Taphoorn MJB, Souhami L, Dinjens WNM, Laack NN, Kouwenhoven MCM, Fink KL, French PJ, Macdonald DR, Lacombe D, Won M, Gorlia T, Mehta MP, van den Bent MJ. Joint Final Report of EORTC 26951 and RTOG 9402: Phase III Trials With Procarbazine, Lomustine, and Vincristine Chemotherapy for Anaplastic Oligodendroglial Tumors. J Clin Oncol. 2022 Aug 10;40(23):2539-2545. doi: 10.1200/JCO.21.02543. Epub 2022 Jun 22.
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PubMed Identifier
23071247
Citation
Cairncross G, Wang M, Shaw E, Jenkins R, Brachman D, Buckner J, Fink K, Souhami L, Laperriere N, Curran W, Mehta M. Phase III trial of chemoradiotherapy for anaplastic oligodendroglioma: long-term results of RTOG 9402. J Clin Oncol. 2013 Jan 20;31(3):337-43. doi: 10.1200/JCO.2012.43.2674. Epub 2012 Oct 15.
Results Reference
derived

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Radiation Therapy With or Without Chemotherapy in Treating Patients With Anaplastic Oligodendroglioma

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