Back to resultsTemozolomide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Anaplastic Oligodendrogliomas or Mixed Anaplastic Oligoastrocytomas
Primary Purpose
Brain and Central Nervous System Tumors
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
temozolomide
neoadjuvant therapy
radiation therapy
Sponsored by
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
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed supratentorial pure or mixed anaplastic oligodendroglioma Unifocal or multifocal disease Prior suspected or proven low-grade glioma eligible provided biopsy reveals pure or mixed anaplastic oligodendroglioma that has not been previously treated with radiotherapy and/or chemotherapy No equivocal oligodendroglial element No tumors predominantly located in the posterior fossa (i.e., brainstem or cerebellum) No spinal cord tumors No evidence of spinal drop metastasis or spread to noncontiguous meninges PATIENT CHARACTERISTICS: Age: 18 to 65 Performance status: Zubrod 0-1 Life expectancy: More than 12 weeks Hematopoietic: Absolute granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than 2 times normal Aspartate aminotransferase (AST) no greater than 3 times normal Alkaline phosphatase no greater than 2 times normal Renal: Creatinine no greater than 1.5 times normal Other: No active infection No other medical problems that would preclude study participation No other malignancy within the past 3 years except carcinoma in situ of the cervix or nonmelanoma skin cancer Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No prior chemotherapy for this malignancy No prior temozolomide Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy to the brain, head, or neck Surgery: At least 14 days since prior surgery requiring general anesthesia
Sites / Locations
- Mobile Infirmary Medical Center
- Foundation for Cancer Research and Education
- CCOP - Mayo Clinic Scottsdale Oncology Program
- Shands Cancer Center at the University of Florida Health Science Center
- Mayo Clinic
- University of Miami Sylvester Cancer Center
- Baptist Hospital of Miami
- Mayo Clinic Cancer Center
- CCOP - Kansas City
- Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
- Monmouth Medical Center
- Wayne Memorial Hospital, Inc.
- Rutherford Hospital
- CCOP - Southeast Cancer Control Consortium
- Akron City Hospital
- Adena Regional Medical Center
- CCOP - Columbus
- Riverside Methodist Hospital
- Mount Carmel West Hospital
- Grady Memorial Hospital
- Fairfield Medical Center
- Strecker Cancer Center at Marietta Memorial Hospital
- Licking Memorial Hospital
- CCOP - Toledo Community Hospital
- CCOP - Columbia River Oncology Program
- Mercy Hospital of Pittsburgh
- Anderson Area Cancer Center
- Cottonwood Hospital Medical Center
- McKay-Dee Hospital Center
- Utah Valley Regional Medical Center - Provo
- Dixie Regional Medical Center
- University of Utah Health Sciences Center
- LDS Hospital
- University Cancer Center at University of Washington Medical Center
- Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
- University of Wisconsin Comprehensive Cancer Center
- CCOP - Marshfield Clinic Research Foundation
- Medical College of Wisconsin Cancer Center
- Saint John Regional Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Pre-RT temozolomide, RT plus temozolomide
Arm Description
Pre-radiation therapy (RT) temozolomide, RT plus temozolomide
Outcomes
Primary Outcome Measures
Rate of progression at 6 months (post-chemotherapy/pre-irradiation progression)
Secondary Outcome Measures
Overall Survival
Full Information
NCT ID
NCT00033280
First Posted
April 9, 2002
Last Updated
October 21, 2020
Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI), NRG Oncology
1. Study Identification
Unique Protocol Identification Number
NCT00033280
Brief Title
Temozolomide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Anaplastic Oligodendrogliomas or Mixed Anaplastic Oligoastrocytomas
Official Title
A Phase II Trial Of Pre-Irradiation And Concurrent Temozolomide In Patients With Newly Diagnosed Anaplastic Oligodendrogliomas And Mixed Anaplastic Oligoastrocytomas
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
May 14, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radiation Therapy Oncology Group
Collaborators
National Cancer Institute (NCI), NRG Oncology
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 and radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining temozolomide with radiation therapy in treating patients who have newly diagnosed anaplastic oligodendrogliomas or mixed anaplastic oligoastrocytomas.
Detailed Description
OBJECTIVES:
Determine the rate of progression in patients with newly diagnosed anaplastic oligodendrogliomas or mixed anaplastic oligoastrocytomas treated with neoadjuvant and concurrent temozolomide with radiotherapy.
Determine the toxicity of this regimen in these patients.
Determine the survival of patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients are stratified according to response to neoadjuvant temozolomide (stable disease or partial response (PR) vs complete response (CR)).
Patients receive oral temozolomide on days 1-7 and 15-21. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with CR or PR receive 2 courses beyond CR or PR.
Within 6 weeks after completion of neoadjuvant temozolomide, patients with stable disease or PR undergo radiotherapy 5 days a week for 6.5 weeks. Patients also receive oral temozolomide daily for 42 days concurrently with radiotherapy.
Patients with CR after completion of neoadjuvant temozolomide undergo observation.
Patients are followed at 9 and 12 months, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A maximum of 37 patients will be accrued for this study within 12 months.
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 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pre-RT temozolomide, RT plus temozolomide
Arm Type
Experimental
Arm Description
Pre-radiation therapy (RT) temozolomide, RT plus temozolomide
Intervention Type
Drug
Intervention Name(s)
temozolomide
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Rate of progression at 6 months (post-chemotherapy/pre-irradiation progression)
Time Frame
From start of treatment to 6 months
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
From registration to date of death or last follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed supratentorial pure or mixed anaplastic oligodendroglioma
Unifocal or multifocal disease
Prior suspected or proven low-grade glioma eligible provided biopsy reveals pure or mixed anaplastic oligodendroglioma that has not been previously treated with radiotherapy and/or chemotherapy
No equivocal oligodendroglial element
No tumors predominantly located in the posterior fossa (i.e., brainstem or cerebellum)
No spinal cord tumors
No evidence of spinal drop metastasis or spread to noncontiguous meninges
PATIENT CHARACTERISTICS:
Age:
18 to 65
Performance status:
Zubrod 0-1
Life expectancy:
More than 12 weeks
Hematopoietic:
Absolute granulocyte count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Hemoglobin at least 10 g/dL
Hepatic:
Bilirubin no greater than 2 times normal
Aspartate aminotransferase (AST) no greater than 3 times normal
Alkaline phosphatase no greater than 2 times normal
Renal:
Creatinine no greater than 1.5 times normal
Other:
No active infection
No other medical problems that would preclude study participation
No other malignancy within the past 3 years except carcinoma in situ of the cervix or nonmelanoma skin cancer
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Not specified
Chemotherapy:
See Disease Characteristics
No prior chemotherapy for this malignancy
No prior temozolomide
Endocrine therapy:
Not specified
Radiotherapy:
See Disease Characteristics
No prior radiotherapy to the brain, head, or neck
Surgery:
At least 14 days since prior surgery requiring general anesthesia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael A. Vogelbaum, MD, PhD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Mobile Infirmary Medical Center
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36652-2144
Country
United States
Facility Name
Foundation for Cancer Research and Education
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
CCOP - Mayo Clinic Scottsdale Oncology Program
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259-5404
Country
United States
Facility Name
Shands Cancer Center at the University of Florida Health Science Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0385
Country
United States
Facility Name
Mayo Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
University of Miami Sylvester Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Baptist Hospital of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33256-2110
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
CCOP - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114-4199
Country
United States
Facility Name
Monmouth Medical Center
City
Long Branch
State/Province
New Jersey
ZIP/Postal Code
07740-6395
Country
United States
Facility Name
Wayne Memorial Hospital, Inc.
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27533
Country
United States
Facility Name
Rutherford Hospital
City
Rutherfordton
State/Province
North Carolina
ZIP/Postal Code
28139-0000
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
Akron City Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44304
Country
United States
Facility Name
Adena Regional Medical Center
City
Chillicothe
State/Province
Ohio
ZIP/Postal Code
45601
Country
United States
Facility Name
CCOP - Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43206
Country
United States
Facility Name
Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Mount Carmel West Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43222
Country
United States
Facility Name
Grady Memorial Hospital
City
Delaware
State/Province
Ohio
ZIP/Postal Code
43015
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
45750-1635
Country
United States
Facility Name
Licking Memorial Hospital
City
Newark
State/Province
Ohio
ZIP/Postal Code
43055-2899
Country
United States
Facility Name
CCOP - Toledo Community Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623-3456
Country
United States
Facility Name
CCOP - Columbia River Oncology Program
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Mercy Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15219
Country
United States
Facility Name
Anderson Area Cancer Center
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621-5705
Country
United States
Facility Name
Cottonwood Hospital Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
McKay-Dee Hospital Center
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
Utah Valley Regional Medical Center - Provo
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States
Facility Name
Dixie Regional Medical Center
City
Saint George
State/Province
Utah
ZIP/Postal Code
84770
Country
United States
Facility Name
University of Utah Health Sciences Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
LDS Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Facility Name
University Cancer Center at University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195-6043
Country
United States
Facility Name
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
CCOP - Marshfield Clinic Research Foundation
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Medical College of Wisconsin Cancer Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Saint John Regional Hospital
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
18779504
Citation
Vogelbaum MA, Berkey B, Peereboom D, Macdonald D, Giannini C, Suh JH, Jenkins R, Herman J, Brown P, Blumenthal DT, Biggs C, Schultz C, Mehta M. Phase II trial of preirradiation and concurrent temozolomide in patients with newly diagnosed anaplastic oligodendrogliomas and mixed anaplastic oligoastrocytomas: RTOG BR0131. Neuro Oncol. 2009 Apr;11(2):167-75. doi: 10.1215/15228517-2008-073. Epub 2008 Sep 8.
Results Reference
result
Citation
Vogelbaum MA, Berkey B, Peereboom D, et al.: RTOG 0131: phase II trial of pre-irradiation and concurrent temozolomide in patients with newly diagnosed anaplastic oligodendrogliomas and mixed anaplastic oligodendrogliomas: relationship between 1p/19q status and progression-free survival. [Abstract] J Clin Oncol 24 (Suppl 18): A-1517, 2006.
Results Reference
result
Citation
Vogelbaum MA, Berkey B, Peereboom D, et al.: RTOG 0131: phase II trial of pre-irradiation and concurrent temozolomide in patients with newly diagnosed anaplastic oligodendrogliomas and mixed anaplastic oligodendrogliomas. [Abstract] J Clin Oncol 23 (Suppl 16): A-1520, 119s, 2005.
Results Reference
result
Learn more about this trial
Temozolomide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Anaplastic Oligodendrogliomas or Mixed Anaplastic Oligoastrocytomas
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