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

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03722355
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Radiation Therapy Oncology Group
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Walter J Curran, Jr., MD
Principal Investigator Affiliation Radiation Therapy Oncology Group
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Completed
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioma, Glioblastoma Multiforme, Astrocytoma
Study Website: View Trial Website
Arms & Interventions

Arms

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

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

Interventions

Radiation: - Conventional RT

Radiation therapy

Radiation: - Hyperfractionated RT

Radiation therapy

Drug: - Carmustine

Chemotherapy

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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