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

November 7, 2019 updated by: Radiation Therapy Oncology Group

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

712

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
Drug: Carmustine
Chemotherapy
Other Names:
  • BCNU
  • Gliadel
Radiation: Hyperfractionated RT
Radiation therapy

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radiation Therapy Oncology Group

Investigators

  • Principal Investigator: Walter J Curran, Jr., MD, Radiation Therapy Oncology Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 1990

Primary Completion (Actual)

March 15, 1994

Study Completion (Actual)

October 18, 2002

Study Registration Dates

First Submitted

October 23, 2018

First Submitted That Met QC Criteria

October 24, 2018

First Posted (Actual)

October 26, 2018

Study Record Updates

Last Update Posted (Actual)

November 12, 2019

Last Update Submitted That Met QC Criteria

November 7, 2019

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RTOG 9006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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