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

Sponsor

Radiation Therapy Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT03722355

Collaborator

(none)

712

Enrollment

Arms

143.3

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glioma Glioblastoma Multiforme Astrocytoma	Radiation: Conventional RT Radiation: Hyperfractionated RT Drug: Carmustine	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

712 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase III Comparison of Hyperfractionated Radiation Therapy (RT) With BCNU and Conventional RT With BCNU for Supratentorial Malignant Glioma

Actual Study Start Date :

Nov 9, 1990

Actual Primary Completion Date :

Mar 15, 1994

Actual Study Completion Date :

Oct 18, 2002

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	Radiation: Conventional RT Radiation therapy Drug: Carmustine Chemotherapy Other Names: BCNU Gliadel
Experimental: 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	Radiation: Hyperfractionated RT Radiation therapy Drug: Carmustine Chemotherapy Other Names: BCNU Gliadel

Arm

Intervention/Treatment

Active Comparator: 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

Radiation: Conventional RT

Radiation therapy

Drug: Carmustine

Chemotherapy

Other Names:

BCNU

Gliadel

Experimental: 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

Radiation: Hyperfractionated RT

Radiation therapy

Drug: Carmustine

Chemotherapy

Other Names:

BCNU

Gliadel

Outcome Measures

Primary Outcome Measures

Overall Survival [From randomization to the date of death or last follow up, assessed up to 131 months.]
Overall Survival

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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