Radiation Therapy Followed by Carmustine in Treating Patients Who Have Supratentorial Glioblastoma Multiforme - Full Text View

Purpose

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	Intervention	Phase
Brain and Central Nervous System Tumors	Drug: carmustine Radiation: radiation therapy Radiation: stereotactic radiosurgery	Phase 2


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase II Trial of Accelerated Radiotherapy Using Weekly Stereotactic Conformal Boosts For Supratentorial Glioblastoma Multiforme

Resource links provided by NLM:

Drug Information available for: Carmustine

Genetic and Rare Diseases Information Center resources: Anaplastic Astrocytoma Glioblastoma Glioma Gliosarcoma Neuroepithelioma

U.S. FDA Resources

Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:

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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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. ] [ Designated as safety issue: No ]


Enrollment:	80
Study Start Date:	March 2001
Study Completion Date:	February 2009
Primary Completion Date:	November 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006386

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

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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
Study First Received:	October 4, 2000
Last Updated:	October 8, 2013
Health Authority:	United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:


adult glioblastoma adult giant cell glioblastoma adult gliosarcoma

Additional relevant MeSH terms:


Central Nervous System Neoplasms Glioblastoma Astrocytoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms by Site	Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroectodermal Tumors

ClinicalTrials.gov processed this record on March 03, 2015