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

Radiation Therapy Oncology Group

Status and phase: Completed; Phase 3

Conditions: Glioma; Glioblastoma Multiforme; Astrocytoma

Treatments: Radiation: Hyperfractionated RT; Radiation: Conventional RT; Drug: Carmustine

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT03722355

RTOG 9006

Details and patient eligibility

About

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.

Enrollment: 712 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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712 participants in 2 patient groups

Arm 1: Conventional RT + Carmustine

Active Comparator group

Description:

Conventional RT: 60.0 Gy/30 fractions/2.0 Gy once daily + carmustine 80 mg/m2 IV on Days 1, 2, 3 of RT then every 8 weeks for 6 cycles

Treatment:

Radiation: Conventional RT

Drug: Carmustine

Arm 2: Hyperfractionated RT + Carmustine

Experimental group

Description:

Hyperfractionated RT: 72.0 Gy/60 fractions/6 weeks/1.2 Gy BID + carmustine 80 mg/m2 IV on Days 1, 2, 3 of RT and then every 8 weeks for 6 cycles

Treatment:

Drug: Carmustine

Radiation: Hyperfractionated RT