Hyperfractionated RT With BCNU Versus Conventional RT With BCNU for Supratentorial Malignant Glioma
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03722355 |
Recruitment Status :
Completed
First Posted : October 26, 2018
Last Update Posted : November 12, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Glioma Glioblastoma Multiforme Astrocytoma | Radiation: Conventional RT Radiation: Hyperfractionated RT Drug: Carmustine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 712 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase III Comparison of Hyperfractionated Radiation Therapy (RT) With BCNU and Conventional RT With BCNU for Supratentorial Malignant Glioma |
Actual Study Start Date : | November 9, 1990 |
Actual Primary Completion Date : | March 15, 1994 |
Actual Study Completion Date : | October 18, 2002 |

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:
|
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
|
Radiation: Hyperfractionated RT
Radiation therapy Drug: Carmustine Chemotherapy
Other Names:
|
- Overall Survival [ Time Frame: From randomization to the date of death or last follow up, assessed up to 131 months. ]Overall Survival

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03722355
Principal Investigator: | Walter J Curran, Jr., MD | Radiation Therapy Oncology Group |
Responsible Party: | Radiation Therapy Oncology Group |
ClinicalTrials.gov Identifier: | NCT03722355 |
Other Study ID Numbers: |
RTOG 9006 |
First Posted: | October 26, 2018 Key Record Dates |
Last Update Posted: | November 12, 2019 |
Last Verified: | October 2018 |
Glioma Glioblastoma Glioblastoma multiforme Astrocytoma |
Glioblastoma Glioma Astrocytoma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Carmustine Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |