Radiosurgery With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases

Metastatic Cancer Clinical Trial

Official title:

A Phase III Randomized Trial Of The Role Of Whole Brain Radiation Therapy In Addition To Radiosurgery In The Management Of Patients With One To Three Cerebral Metastases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00030628
• Other study ID #: ACOSOG-Z0300
• Secondary ID: ACOSOG-Z0300CDR0
• Status: Completed
• Phase: Phase 3
• First received: February 14, 2002
• Last updated: July 6, 2016
• Start date: December 2001
• Est. completion date: October 2014

Study information

• Verified date: July 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiosurgery may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known if radiosurgery is more effective with or without whole-brain radiation therapy in treating brain metastases.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiosurgery with or without whole-brain radiation therapy in treating patients who have brain metastases.

Description:

OBJECTIVES:

• Compare the overall survival of patients with 1 to 3 cerebral metastases treated with radiosurgery with or without whole brain radiotherapy.

• Compare the time to CNS failure (brain) in patients treated with these regimens.

• Compare the quality of life, duration of functional independence, and long-term neurocognitive status in patients treated with these regimens.

• Compare the post-treatment toxic effects of these regimens in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (60 and over vs under 60), extracranial disease (controlled for more than 3 months vs controlled for 3 months or less), and number of brain metastases (1 vs more than 1). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients undergo radiosurgery.

• Arm II: Patients undergo radiosurgery. Within 14 days, patients then undergo whole brain radiotherapy 5 days a week for 2.5 weeks.

Quality of life is assessed at baseline, the beginning of each treatment, at week 6, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 2 years.

Patients are followed at weeks 6 and 12, every 3 months for 9 months, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 480 patients (240 per treatment arm) will be accrued for this study within 5 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 480
• Est. completion date: October 2014
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of cerebral metastases meeting all of the following requirements:

• 1-3 de novo lesions

• Metastases must be from a histologically confirmed extracerebral primary site, another metastatic site, or from the metastatic brain lesion(s)

• Each lesion must be less than 3.0 cm by contrasted MRI of the brain

• Lesions must not be within 5 mm of optic chiasm or within the brainstem

• No primary germ cell tumor, small cell carcinoma, or lymphoma

• No leptomeningeal metastases

• Eligible for treatment with gamma knife or linear accelerator-based radiosurgery

• Performance status - ECOG 0-2

• Performance status - Zubrod 0-2

• Not pregnant

• Negative pregnancy test

• Fertile patients must use effective contraception

• Male patients must continue to use contraception for 3 months after the completion of radiotherapy

• No pacemaker or other MRI-incompatible metal in body

• No known allergy to gadolinium

• Deemed to be at low risk for recurrence from any prior malignancies

• At least 7 days since prior chemotherapy

• Concurrent hormonal agents allowed

• Concurrent steroids allowed

• No prior cranial radiotherapy

• No prior resection of cerebral metastasis

• Concurrent anticonvulsants allowed provided therapeutic serum/plasma level maintained before study intervention

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Radiation:
• radiation therapy

Procedure:
• surgery

Radiation:
• WBRT

Locations

Country	Name	City	State
United States	American Fork Hospital	American Fork	Utah
United States	University of Colorado Cancer Center at University of Colorado Health Sciences Center	Aurora	Colorado
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland
United States	University of Alabama at Birmingham Comprehensive Cancer Center	Birmingham	Alabama
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Blumenthal Cancer Center at Carolinas Medical Center	Charlotte	North Carolina
United States	Carolina Neurosurgery and Spine Associates	Charlotte	North Carolina
United States	Cancer Center at the University of Virginia	Charlottesville	Virginia
United States	University of Illinois Medical Center	Chicago	Illinois
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Mount Diablo Regional Cancer Center	Concord	California
United States	Genesis Regional Cancer Center at Genesis Medical Center	Davenport	Iowa
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	Josephine Ford Cancer Center at Henry Ford Health System	Detroit	Michigan
United States	American College of Surgeons Oncology Group	Durham	North Carolina
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	John F. Kennedy Medical Center	Edison	New Jersey
United States	Shands Cancer Center at the University of Florida Health Science Center	Gainesville	Florida
United States	Penn State Cancer Institute at Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center	Kansas City	Kansas
United States	University of Wisconsin Comprehensive Cancer Center	Madison	Wisconsin
United States	Methodist Cancer Center at Methodist University Hospital	Memphis	Tennessee
United States	Medical College of Wisconsin Cancer Center	Milwaukee	Wisconsin
United States	Yale Comprehensive Cancer Center	New Haven	Connecticut
United States	Foundation for Cancer Research and Education	Phoenix	Arizona
United States	St. Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center - Shadyside Hospital	Pittsburgh	Pennsylvania
United States	UPMC St. Margaret	Pittsburgh	Pennsylvania
United States	Massey Cancer Center at Virginia Commonwealth University	Richmond	Virginia
United States	Sutter Cancer Center	Sacramento	California
United States	Siteman Cancer Center at Barnes-Jewish Hospital	Saint Louis	Missouri
United States	UCSF Comprehensive Cancer Center	San Francisco	California
United States	SUNY Upstate Medical University Hospital	Syracuse	New York
United States	John Muir Comprehensive Cancer Center at John Muir Medical Center	Walnut Creek	California
United States	Comprehensive Cancer Center at Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)		Up to 6 months	No
Secondary	Time to CNS failure		Up to 4 years	No
Secondary	Change in QOL between SRS and SRS + WBRT treatment groups using the FACT-BR questionnaire		From baseline to up to 3 months	No
Secondary	Change in the duration of functional independence using the Barthel ADL Index score		From baseline to up to 4 years	No