Hyperfractionated RT With BCNU Versus Conventional RT With BCNU for Supratentorial Malignant Glioma

• Status: Completed
• Trial end date: 2002-10-18
• Target enrollment: 0
• Participant gender: All

Summary

Hyperfractionated radiation therapy (RT) to 72.0 Gy with BCNU will be compared to conventional radiation therapy to 60.0 Gy with BCNU to determine if hyperfractionated RT can improve the median survival time of adults with supratentorial malignant gliomas.

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

Details

• Lead Sponsor: Radiation Therapy Oncology Group
• Treatments: Carmustine

Criteria

Inclusion Criteria:

• Histopathologically confirmed glioblastoma multiforme (with areas of necrosis), malignant astrocytoma and astrocytoma with foci of anaplasia

• Karnofsky Performance Score ≥ 60

• Absolute Neutrophil count ≥ 1,500

• Platelets ≥ 100,000

• BUN ≤ 25

• Creatinine ≤ 1.5

• Bilirubin ≤ 2.0

• Hemoglobin ≥ 10 gm

• SGOT < 2 x upper limit of normal

• SGPT < 2 x upper limit of normal

Exclusion Criteria:

• No prior radiation to the head or neck area, chemotherapy or radiosensitizer

• No malignancy with the past five years except non-melanomatous skin cancer or carcinoma in-situ of the cervix