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Completed

NCT Number: NCT03722355

Hyperfractionated RT With BCNU Versus 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.

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Key information

Conditions

Glioma Astrocytoma Glioblastoma Glioblastoma Multiforme Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional RT

Radiation

Radiation therapy

Hyperfractionated RT

Radiation

Radiation therapy

carmustine

Drug

Chemotherapy

Other names: BCNU, Gliadel

Primary outcomes

  1. Overall Survival

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

    Overall Survival

Sponsors and collaborators

Lead sponsor

Radiation Therapy Oncology Group

Network

Registry information

Official study title

A Phase III Comparison of Hyperfractionated Radiation Therapy (RT) With BCNU and Conventional RT With BCNU for Supratentorial Malignant Glioma

Important dates

Study start
1990
Primary completion
1994
Study completion
2002
First posted
Oct 26, 2018
Registry last updated
Nov 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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