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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03722355

Enrollment

712

Registered

2018-10-26

Start date

1990-11-09

Completion date

2002-10-18

Last updated

2019-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Astrocytoma, Glioblastoma Multiforme, Glioma

Keywords

Glioma, Glioblastoma, Glioblastoma multiforme, Astrocytoma

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.

Interventions

RADIATIONConventional RT

Radiation therapy

RADIATIONHyperfractionated RT

Radiation therapy

DRUGCarmustine

Chemotherapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Overall Survival	From randomization to the date of death or last follow up, assessed up to 131 months.	Overall Survival

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026