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

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ClinicalTrials.gov Identifier: NCT03722355
Recruitment Status : Completed
First Posted : October 26, 2018
Last Update Posted : November 12, 2019
Sponsor:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Study Description
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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.

Condition or disease Intervention/treatment Phase
Glioma Glioblastoma Multiforme Astrocytoma Radiation: Conventional RT Radiation: Hyperfractionated RT Drug: Carmustine Phase 3

Study Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: Carmustine

Arms and Interventions
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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
 Radiation: Hyperfractionated RT
Radiation therapy

Drug: Carmustine
Chemotherapy
Other Names:
  • BCNU
  • Gliadel


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival [ Time Frame: From randomization to the date of death or last follow up, assessed up to 131 months. ]
    Overall Survival


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
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Principal Investigator: Walter J Curran, Jr., MD Radiation Therapy Oncology Group
More Information
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Additional Information:
Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive.  This link exits the ClinicalTrials.gov site

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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
Keywords provided by Radiation Therapy Oncology Group:
Glioma
Glioblastoma
Glioblastoma multiforme
Astrocytoma
Additional relevant MeSH terms:
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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