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

Phase 3

Completed

• Conditions: Glioblastoma Multiforme; Glioma; Astrocytoma
• Interventions: Radiation: Hyperfractionated RT; Radiation: Conventional RT; Drug: Carmustine

• Registration Number: NCT03722355
• Lead Sponsor: Radiation Therapy Oncology Group

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 1990-11-09
• Primary Completion: 1994-03-15
• Study Completion: 2002-10-18
• Status Verified: 2018-10
• Study First Submitted: 2018-10-23
• Study First Submitted QC: 2018-10-24
• Study First Posted: 2018-10-26
• Last Update Submitted: 2019-11-07
• Last Update Posted: 2019-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 712

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2: Hyperfractionated RT + Carmustine	Hyperfractionated RT	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
Arm 1: Conventional RT + Carmustine	Conventional RT	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
Arm 1: Conventional RT + Carmustine	Carmustine	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
Arm 2: Hyperfractionated RT + Carmustine	Carmustine	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

Primary Outcome Measures

Name	Time	Method
Overall Survival	From randomization to the date of death or last follow up, assessed up to 131 months.	Overall Survival