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

Radiation Therapy Oncology Group712 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

712

Conditions

Glioma Glioblastoma Multiforme Astrocytoma

Interventions

Conventional RTRADIATION

Radiation therapy

Hyperfractionated RTRADIATION

Radiation therapy

CarmustineDRUG

Chemotherapy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Overall Survival

Time frame: From randomization to the date of death or last follow up, assessed up to 131 months.

Data from ClinicalTrials.gov

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