NCT00002569

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

Study Contact:

Study Phase:

PHASE3

Recruitment Status:

COMPLETED

NCT ID:

NCT00002569

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

Phase III Intergroup Randomized Comparison of Radiation Alone vs. Pre-Radiation Chemotherapy for Pure and Mixed Anaplastic Oligodendrogliomas

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.

Eligibility

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

Disease(s) and\or Condition(s)

Brain and Central Nervous System Tumors

Primary Purpose

TREATMENT

Intervention/Treatment

- Type: DRUG
- Name: lomustine
- Description:
- Arm Group Labels: Intensive pre-treatment chemotherapy and radiation therapy
- Type: DRUG
- Name: procarbazine hydrochloride
- Description:
- Arm Group Labels: Intensive pre-treatment chemotherapy and radiation therapy
- Type: DRUG
- Name: vincristine sulfate
- Description:
- Arm Group Labels: Intensive pre-treatment chemotherapy and radiation therapy
- Type: RADIATION
- Name: radiation therapy
- Description:
- Arm Group Labels: Intensive pre-treatment chemotherapy and radiation therapy, Radiation therapy (RT) alone

Sponsor

Radiation Therapy Oncology Group