Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 to 65 NCI RTOG-BR-0131 RTOG-DEV-1080, NCT00033280

Objectives

1. Determine the rate of progression in patients with newly diagnosed anaplastic oligodendrogliomas or mixed anaplastic oligoastrocytomas treated with neoadjuvant and concurrent temozolomide with radiotherapy.
2. Determine the toxicity of this regimen in these patients.
3. Determine the survival of patients treated with this regimen.

Entry 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

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

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/mm³
• Platelet count at least 100,000/mm³
• Hemoglobin at least 10 g/dL

Hepatic:

• Bilirubin no greater than 2 times normal
• 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

Expected Enrollment

A maximum of 37 patients will be accrued for this study within 12 months.

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.

Vogelbaum MA, Berkey B, Peereboom D, et al.: Phase II trial of pre-irradiation and concurrent temozolomide in patients with newly diagnosed anaplastic oligodendrogliomas and mixed anaplastic oligoastrocytomas: RTOG BR0131. Neuro Oncol : , 2008.[PUBMED Abstract]

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.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

Michael Vogelbaum, MD, PhD, Protocol chair		Ph: 216-444-8564; 800-862-7798

Registry Information
Official Title		A Phase II Trial Of Pre-Irradiation And Concurrent Temozolomide In Patients With Newly Diagnosed Anaplastic Oligodendrogliomas And Mixed Anaplastic Oligoastrocytomas
Trial Start Date		2002-07-30
Registered in ClinicalTrials.gov		NCT00033280
Date Submitted to PDQ		2002-02-05
Information Last Verified		2004-04-27
NCI Grant/Contract Number		CA21661

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