Temozolomide Plus Radiation Therapy in Treating Patients With Newly Diagnosed Anaplastic Oligodendrogliomas or Mixed Anaplastic Oligoastrocytomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00033280
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 17, 2018
National Cancer Institute (NCI)
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

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.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Drug: temozolomide Procedure: neoadjuvant therapy Radiation: radiation therapy Phase 2

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial Of Pre-Irradiation And Concurrent Temozolomide In Patients With Newly Diagnosed Anaplastic Oligodendrogliomas And Mixed Anaplastic Oligoastrocytomas
Study Start Date : July 2002
Actual Primary Completion Date : April 2005
Actual Study Completion Date : May 14, 2018

Arm Intervention/treatment
Experimental: Pre-RT temozolomide, RT plus temozolomide
Pre-radiation therapy (RT) temozolomide, RT plus temozolomide
Drug: temozolomide
Procedure: neoadjuvant therapy
Radiation: radiation therapy

Primary Outcome Measures :
  1. Rate of progression at 6 months (post-chemotherapy/pre-irradiation progression) [ Time Frame: From start of treatment to 6 months ]

Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: From registration to date of death or last follow-up ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 to 65

Performance status:

  • Zubrod 0-1

Life expectancy:

  • More than 12 weeks


  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL


  • Bilirubin no greater than 2 times normal
  • Aspartate aminotransferase (AST) no greater than 3 times normal
  • Alkaline phosphatase no greater than 2 times normal


  • Creatinine no greater than 1.5 times normal


  • 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


Biologic therapy:

  • Not specified


  • See Disease Characteristics
  • No prior chemotherapy for this malignancy
  • No prior temozolomide

Endocrine therapy:

  • Not specified


  • See Disease Characteristics
  • No prior radiotherapy to the brain, head, or neck


  • At least 14 days since prior surgery requiring general anesthesia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00033280

  Hide Study Locations
United States, Alabama
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36652-2144
United States, Arizona
Foundation for Cancer Research and Education
Phoenix, Arizona, United States, 85013
CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale, Arizona, United States, 85259-5404
United States, Florida
Shands Cancer Center at the University of Florida Health Science Center
Gainesville, Florida, United States, 32610-0385
Mayo Clinic
Jacksonville, Florida, United States, 32224
University of Miami Sylvester Cancer Center
Miami, Florida, United States, 33136
Baptist Hospital of Miami
Miami, Florida, United States, 33256-2110
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
United States, Missouri
CCOP - Kansas City
Kansas City, Missouri, United States, 64131
United States, Nebraska
Methodist Hospital Cancer Center at Nebraska Methodist Hospital - Omaha
Omaha, Nebraska, United States, 68114-4199
United States, New Jersey
Monmouth Medical Center
Long Branch, New Jersey, United States, 07740-6395
United States, North Carolina
Wayne Memorial Hospital, Inc.
Goldsboro, North Carolina, United States, 27533
Rutherford Hospital
Rutherfordton, North Carolina, United States, 28139-0000
CCOP - Southeast Cancer Control Consortium
Winston-Salem, North Carolina, United States, 27104-4241
United States, Ohio
Akron City Hospital
Akron, Ohio, United States, 44304
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
CCOP - Columbus
Columbus, Ohio, United States, 43206
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Mount Carmel West Hospital
Columbus, Ohio, United States, 43222
Grady Memorial Hospital
Delaware, Ohio, United States, 43015
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, United States, 45750-1635
Licking Memorial Hospital
Newark, Ohio, United States, 43055-2899
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43623-3456
United States, Oregon
CCOP - Columbia River Oncology Program
Portland, Oregon, United States, 97225
United States, Pennsylvania
Mercy Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15219
United States, South Carolina
Anderson Area Cancer Center
Anderson, South Carolina, United States, 29621-5705
United States, Utah
Cottonwood Hospital Medical Center
Murray, Utah, United States, 84107
McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States, 84604
Dixie Regional Medical Center
Saint George, Utah, United States, 84770
University of Utah Health Sciences Center
Salt Lake City, Utah, United States, 84132
LDS Hospital
Salt Lake City, Utah, United States, 84143
United States, Washington
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
United States, Wisconsin
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, United States, 54449
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
Canada, New Brunswick
Saint John Regional Hospital
Saint John, New Brunswick, Canada, E2L 4L2
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
NRG Oncology
Study Chair: Michael A. Vogelbaum, MD, PhD The Cleveland Clinic

Publications of Results:
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.
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.

Responsible Party: Radiation Therapy Oncology Group Identifier: NCT00033280     History of Changes
Other Study ID Numbers: RTOG-BR-0131
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Radiation Therapy Oncology Group:
adult anaplastic oligodendroglioma
adult mixed glioma

Additional relevant MeSH terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents