This trial is active, not recruiting.

Condition brain and central nervous system tumors
Treatments temozolomide, neoadjuvant therapy, radiation therapy
Phase phase 2
Sponsor Radiation Therapy Oncology Group
Collaborator National Cancer Institute (NCI)
Start date July 2002
End date April 2005
Trial size 42 participants
Trial identifier NCT00033280, CDR0000069270, RTOG-BR-0131, RTOG-DEV-1080


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Pre-radiation therapy (RT) temozolomide, RT plus temozolomide
neoadjuvant therapy
radiation therapy

Primary Outcomes

Rate of progression at 6 months (post-chemotherapy/pre-irradiation progression)
time frame: From start of treatment to 6 months

Secondary Outcomes

Overall Survival
time frame: From registration to date of death or last follow-up

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title A Phase II Trial Of Pre-Irradiation And Concurrent Temozolomide In Patients With Newly Diagnosed Anaplastic Oligodendrogliomas And Mixed Anaplastic Oligoastrocytomas
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Radiation Therapy Oncology Group.