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
• Status: Completed
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Astrocytoma
• Glioblastoma
• Glioblastoma Multiforme
• Glioma

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.

External Links

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