Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	Not specified	NCI	RTOG-BR-0023 RTOG-DEV-1040, NCT00006386

Objectives

1. 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.
2. Determine the short and long-term toxicity of this regimen in these patients.
3. Determine the feasibility of this regimen in these patients.

Entry Criteria

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

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

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/mm³
• Platelet count greater than 100,000/mm³

Hepatic:

• Bilirubin less than 2.0 mg/dL
• SGPT or SGOT less than 2 times normal

Renal:

• Creatinine less than 1.8 mg/dL
• BUN less than 30 mg/dL

Pulmonary:

• Chest x-ray normal

  OR

• 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

Expected Enrollment

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

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.

Cardinale R, Won M, Choucair A, et al.: A phase II trial of accelerated radiotherapy using weekly stereotactic conformal boosts for supratentorial glioblastoma multiforme. RTOG-0023. [Abstract] J Clin Oncol 23 (Suppl 16): A-1511, 116s, 2005.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

Rupert Schmidt-Ullrich, MD, Protocol chair(Contact information may not be current)		Ph: 804-828-7238 Email: rullrich@hsc.vcu.edu

Registry Information
Official Title		A Phase II Trial of Accelerated Radiotherapy Using Weekly Stereotactic Conformal Boosts For Supratentorial Glioblastoma Multiforme
Trial Start Date		2001-03-05
Registered in ClinicalTrials.gov		NCT00006386
Date Submitted to PDQ		2000-08-30
Information Last Verified		2003-03-27
NCI Grant/Contract Number		CA21661