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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Brain and Central Nervous System Tumors	Drug: carmustine; Radiation: radiation therapy; Radiation: stereotactic radiosurgery	Phase 2

Detailed Description:

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.

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	80 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Phase II Trial of Accelerated Radiotherapy Using Weekly Stereotactic Conformal Boosts For Supratentorial Glioblastoma Multiforme
Study Start Date :	March 2001
Actual Primary Completion Date :	November 2004
Actual Study Completion Date :	February 2009

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: External beam radiotherapy with stereotactic boost; External beam radiotherapy (EBXRT): 50 Gy in 25 daily fractions of 2 Gy. Stereotactic radiotherapy (SRT) boost: 4 treatments of 5 or 7 Gy, once per week during weeks 3-6. Patients will not receive EBXRT on the SRT treatment days.	Drug: carmustine Radiation: radiation therapy Radiation: stereotactic radiosurgery

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

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 Outcome Measures :

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. ]

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

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

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 236 Study Locations

Sponsors and Collaborators

Radiation Therapy Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:	Robert M. Cardinale, MD	MCV Hospitals

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

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.

Responsible Party:	Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:	NCT00006386 History of Changes
Other Study ID Numbers:	RTOG-BR-0023; CDR0000068264; RTOG-DEV-1040
First Posted:	January 27, 2003
Last Update Posted:	November 17, 2015
Last Verified:	November 2015

Keywords provided by Radiation Therapy Oncology Group:

adult glioblastoma; adult giant cell glioblastoma; adult gliosarcoma

Additional relevant MeSH terms:

Glioblastoma; Nervous System Neoplasms; Central Nervous System Neoplasms; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms	Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neoplasms by Site; Nervous System Diseases; Carmustine; Antineoplastic Agents, Alkylating; Alkylating Agents; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents