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

NCT ID: NCT03722355

Last Updated: 2019-11-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 712 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1990-11-09
• Study Completion Date: 2002-10-18

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.

Conditions

Glioma; Glioblastoma Multiforme; Astrocytoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1: Conventional RT + 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

Group Type: ACTIVE_COMPARATOR

Conventional RT

Intervention Type: RADIATION

Radiation therapy

Carmustine

Intervention Type: DRUG

Chemotherapy

Arm 2: Hyperfractionated RT + 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

Group Type: EXPERIMENTAL

Hyperfractionated RT

Intervention Type: RADIATION

Radiation therapy

Carmustine

Intervention Type: DRUG

Chemotherapy

Interventions

Conventional RT

Radiation therapy

Intervention Type: RADIATION

Hyperfractionated RT

Radiation therapy

Intervention Type: RADIATION

Carmustine

Chemotherapy

Intervention Type: DRUG

Other Intervention Names

BCNU; Gliadel

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Radiation Therapy Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Walter J Curran, Jr., MD

Role: PRINCIPAL_INVESTIGATOR

Radiation Therapy Oncology Group

Related Links

https://nctn-data-archive.nci.nih.gov/

Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.

Other Identifiers

RTOG 9006

Identifier Type: -

Identifier Source: org_study_id