Skip to main content
OpenTrials
Completed

NCT Number: NCT00006386

Radiation Therapy Followed by Carmustine in Treating Patients Who Have Supratentorial Glioblastoma Multiforme

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of radiation therapy followed by carmustine in treating patients who have supratentorial glioblastoma multiforme.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tom Baker Cancer Center - Calgary, Calgary, Alberta, Canada

Loading trial locations.

About this study

OBJECTIVES:

  • Determine the overall and progression-free survival in patients with supratentorial glioblastoma multiforme treated with accelerated radiotherapy and conformal stereotactic radiotherapy boost followed by carmustine.
  • Determine the short and long-term toxicity of this regimen in these patients.
  • Determine the feasibility of this regimen in these patients.

OUTLINE: Patients receive daily accelerated radiotherapy 5 days a week on weeks 1-2. On weeks 3-6, patients receive accelerated radiotherapy 4 days a week (3 days a week on week 6) and conformal stereotactic radiotherapy boost once weekly. Patients then receive carmustine IV over 1-2 hours on days 1-3 every 8 weeks for 6 courses beginning within 1 month after the completion of radiotherapy.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 76 patients will be accrued for this study within 15 months.

Who can participate

Healthy volunteers accepted: No

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed supratentorial glioblastoma multiforme by surgical biopsy or resection within 5 weeks of study
  • Postoperative residual contrast enhancing tumor and resection tumor cavity together no greater than 60 mm in maximum diameter
  • No well-differentiated or anaplastic astrocytomas or multifocal glioma
  • No tumors originating in the brainstem
  • No residual tumor within 10 mm of optic chiasm
  • No recurrent glioblastoma multiforme

PATIENT CHARACTERISTICS:

Age:

  • Not specified

Performance status:

  • Zubrod 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Hemoglobin greater than 9 g/dL
  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic:

  • Bilirubin less than 2.0 mg/dL
  • Serum glutamate pyruvate transaminase (SGPT) or serum glutamate oxaloacetate transaminase (SGOT) less than 2 times normal

Renal:

  • Creatinine less than 1.8 mg/dL
  • Blood urea nitrogen (BUN) less than 30 mg/dL

Pulmonary:

  • Chest x-ray normal OR
  • Diffusion capacity of lung for carbon monoxide (DLCO) greater than 60% predicted

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Neurologic functional status 0-3
  • No other prior malignancy within the past 5 years except carcinoma in situ of the cervix or bladder, ductal carcinoma in situ of the breast, or nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Concurrent steroids allowed

Radiotherapy:

  • Not specified

Surgery:

  • See Disease Characteristics

Other:

  • Concurrent anticonvulsants allowed

Treatment and study plan

carmustine

Drug

radiation therapy

Radiation

Stereotactic Radiosurgery

Radiation

Primary outcomes

  1. Overall Survival

    Time frame: From registration to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 18 months.

Secondary outcomes

  1. Progression-free Survival

    Time frame: From registration to date of progression, death or last follow-up. Analysis occurs at the same time as the primary outcome analysis.

Sponsors and collaborators

Lead sponsor

Radiation Therapy Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

A Phase II Trial of Accelerated Radiotherapy Using Weekly Stereotactic Conformal Boosts For Supratentorial Glioblastoma Multiforme

Important dates

Study start
2001
Primary completion
2004
Study completion
2009
First posted
Jan 27, 2003
Registry last updated
Oct 22, 2020

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.

Published trials that share one or more normalized conditions with this study.