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NCT03722355 Clinical Trial

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

Glioma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03722355
Other study ID # RTOG 9006
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 9, 1990
Est. completion date October 18, 2002

Study information
Verified date October 2018
Source Radiation Therapy Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 712
Est. completion date October 18, 2002
Est. primary completion date March 15, 1994
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Radiation:
• Conventional RT
Radiation therapy
• Hyperfractionated RT
Radiation therapy
Drug:
• Carmustine
Chemotherapy

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Radiation Therapy Oncology Group

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