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

NCT03722355 | Completed Phase 3 DMC

• 1 other identifier: RTOG 9006
• Study Type: interventional
• Target: 712
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Glioma; Glioblastoma Multiforme; Astrocytoma

Keywords

Glioma; Glioblastoma; Glioblastoma multiforme; Astrocytoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Overall Survival

  From randomization to the date of death or last follow up, assessed up to 131 months.

Study Arms (2)

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

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

Radiation: Hyperfractionated RT; Drug: Carmustine

Interventions

Conventional RT RADIATION

Radiation therapy

Arm 1: Conventional RT + Carmustine

Hyperfractionated RT RADIATION

Radiation therapy

Arm 2: Hyperfractionated RT + Carmustine

Carmustine DRUG

Chemotherapy

Also known as: BCNU, Gliadel

Arm 1: Conventional RT + Carmustine; Arm 2: Hyperfractionated RT + Carmustine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Radiation Therapy Oncology Group: lead

Related Links

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

MeSH Terms

Conditions

Glioma; Glioblastoma; Astrocytoma

Interventions

Carmustine; carmustine, poliferprosan 20 drug combination

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds

Study Officials

• Walter J Curran, Jr., MD

  Radiation Therapy Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: October 26, 2018
• Study Start: November 9, 1990
• Primary Completion: March 15, 1994
• Study Completion: October 18, 2002
• Last Updated: November 12, 2019

Record last verified: 2018-10