Observation or Radiation Therapy With or Without Combination Chemotherapy in Treating Patients With Low-Grade Glioma

• Status: Completed
• Trial end date: 2018-05-14
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether radiation therapy combined with chemotherapy is more effective than radiation therapy alone in treating patients with low-grade glioma.

PURPOSE: Phase II/III trial to evaluate observation and to compare the effectiveness of radiation therapy with or without combination chemotherapy in treating patients with low-grade glioma.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radiation Therapy Oncology Group
• Collaborators: Eastern Cooperative Oncology Group; National Cancer Institute (NCI); North Central Cancer Treatment Group; NRG Oncology; Southwest Oncology Group
• Treatments: Lomustine; Procarbazine; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed unifocal or multifocal supratentorial WHO grade II astrocytoma (diffuse fibrillary, protoplasmic, or gemistocytic), oligodendroglioma, or oligoastrocytoma

• Patients with neurofibromatosis are eligible

• No other low-grade histologies, including:

• Pilocytic astrocytoma

• Subependymal giant cell astrocytoma of tuberous sclerosis

• Subependymoma

• Pleomorphic xanthoastrocytoma

• Presence of a neuronal element such as ganglioglioma

• Dysneuroembryoplastic epithelial tumor

• No presence of any high-grade glioma, including:

• Anaplastic astrocytoma

• Glioblastoma multiforme

• Anaplastic oligodendroglioma

• Anaplastic oligoastrocytoma

• No tumors in nonsupratentorial or other locations including optic chiasm, optic nerve(s), pons, medulla, cerebellum, or spinal cord

• No evidence of spread to spinal meninges or noncontiguous cranial meninges (i.e., leptomeningeal gliomatosis)

• No gliomatosis cerebri

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Hematopoietic:

• For high-risk patients:

• Granulocyte count at least 1,500/mm^3

• Platelet count normal

Hepatic:

• Bilirubin no greater than 2 times normal

• SGOT or SGPT no greater than 4 times normal

• Alkaline phosphatase no greater than 2 times normal

Renal:

• Creatinine no greater than 2 times normal

Pulmonary:

• No chronic lung disease (unless DLCO at least 60%)

Neurological:

• Neurologic function score no greater than 3

Other:

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No other malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer

• No active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy to the head or neck (unless brain is clearly excluded, such as radiotherapy for localized vocal cord cancer)

Surgery:

• Not specified