Trial | NCT03722355  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    Carmustine ...

  • Study Participants

    712
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.
Study Started
Nov 09
1990
Primary Completion
Mar 15
1994
Study Completion
Oct 18
2002
Last Update
Nov 12
2019

Radiation Conventional RT

Radiation therapy

Radiation Hyperfractionated RT

Radiation therapy

Drug Carmustine

Chemotherapy

  • Other names: BCNU, Gliadel

Arm 1: Conventional RT + Carmustine Active Comparator

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 Experimental

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

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
No Results Posted