GliomaPhase 3NCT03722355
Hyperfractionated RT With BCNU Versus Conventional RT With BCNU for Supratentorial Malignant Glioma
A Phase 3 study testing Conventional RT, Hyperfractionated RT and Carmustine in people with Glioma and Glioblastoma Multiforme, run by Radiation Therapy Oncology Group.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma, Glioblastoma Multiforme, Astrocytoma
- What is being tested?
- Conventional RT, Hyperfractionated RT and Carmustine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 712 participants
- Where
- No sites listed yet
- Study dates
- 9 Nov 1990to 18 Oct 2002
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- Bilirubin ≤ 2.0
- Hemoglobin ≥ 10 gm
- SGOT < 2 x upper limit of normal
- SGPT < 2 x upper limit of normal
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Glioma, Glioblastoma Multiforme, Astrocytoma
- Being tested
- Conventional RT, Hyperfractionated RT, Carmustine
- Keywords
- Glioma, Glioblastoma, Glioblastoma multiforme, Astrocytoma
- Medical subject headings
- Glioma, Glioblastoma, Astrocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional RTRadiation
Radiation therapy
Hyperfractionated RTRadiation
Radiation therapy
CarmustineDrug
Also called BCNU, Gliadel
Chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Conventional RT + Carmustine | Active comparator | 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 Receives: Radiation: Conventional RT; Drug: Carmustine |
| Arm 2: Hyperfractionated RT + Carmustine | Experimental | 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 Receives: Radiation: Hyperfractionated RT; Drug: Carmustine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Overall Survival
Measured: From randomization to the date of death or last follow up, assessed up to 131 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start9 Nov 1990
- Primary completion15 Mar 1994
- Study completion18 Oct 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 712 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radiation Therapy Oncology Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Walter J Curran, Jr., MD, Principal investigator, Radiation Therapy Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03722355
- Sponsor's protocol ID
- RTOG 9006
- Status last verified
- Oct 2018
- First submitted
- 23 Oct 2018
- Last updated
- 12 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brown MH, Cherng HR, Assif JW, Sun K, Mishra MV. Conditional Survival Estimates for Malignant Glioma Patients: Secondary Analysis of RTOG 9006. Am J Clin Oncol. 2026 Jun 1;49(6):264-267. doi: 10.1097/COC.0000000000001296. Epub 2026 Mar 19.
PubMed 41850328
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Comparison of Hyperfractionated Radiation Therapy (RT) With BCNU and Conventional RT With BCNU for Supratentorial Malignant Glioma
- ClinicalTrials.gov ID
- NCT03722355
- Acronym / sponsor ID
- RTOG 9006
- Conditions
- Glioma, Glioblastoma Multiforme, Astrocytoma
- Keywords
- Glioma, Glioblastoma, Glioblastoma multiforme, Astrocytoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 712 participants (actual)
- Lead sponsor
- Radiation Therapy Oncology GroupResearch network
- Study start
- 9 Nov 1990 (actual)
- Primary completion
- 15 Mar 1994 (actual)
- Study completion
- 18 Oct 2002 (actual)
- First posted
- 26 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Conventional RT + Carmustine | Active comparator | Radiation: Conventional RT, Drug: CarmustineConventional 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 |
| Arm 2: Hyperfractionated RT + Carmustine | Experimental | Radiation: Hyperfractionated RT, Drug: CarmustineHyperfractionated 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional RTRadiation therapy | Radiation | Arm 1: Conventional RT + Carmustine |
| Hyperfractionated RTRadiation therapy | Radiation | Arm 2: Hyperfractionated RT + Carmustine |
| CarmustineAlso: BCNU, GliadelChemotherapy | Drug | Arm 1: Conventional RT + Carmustine, Arm 2: Hyperfractionated RT + Carmustine |
Primary outcome
Overall Survival
Time frame: From randomization to the date of death or last follow up, assessed up to 131 months.
Overall Survival
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2019.
- Derived from this study: PubMed 41850328Brown MH, Cherng HR, Assif JW, Sun K, Mishra MV. Conditional Survival Estimates for Malignant Glioma Patients: Secondary Analysis of RTOG 9006. Am J Clin Oncol. 2026 Jun 1;49(6):264-267. doi: 10.1097/COC.0000000000001296. Epub 2026 Mar 19.
- Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Walter J Curran, Jr., MD principal investigator
Radiation Therapy Oncology Group
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Conventional RT, Hyperfractionated RT and Carmustine in people with Glioma and Glioblastoma Multiforme, run by Radiation Therapy Oncology Group.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: From randomization to the date of death or last follow up, assessed up to 131 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03722355, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2019; AzTrials last refreshed its copy on 29 Oct 2026.