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

Phase 3

Completed

• Conditions: Metastatic Cancer

• Registration Number: NCT00030628
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2001-12
• Study First Submitted: 2002-02-14
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2005-03
• Study Completion: 2014-10
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-06
• Last Update Posted: 2016-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 480

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	Up to 6 months

Secondary Outcome Measures

Name	Time	Method
Time to CNS failure	Up to 4 years
Change in QOL between SRS and SRS + WBRT treatment groups using the FACT-BR questionnaire	From baseline to up to 3 months
Change in the duration of functional independence using the Barthel ADL Index score	From baseline to up to 4 years

Trial Locations

Locations (37)

University of Alabama at Birmingham Comprehensive Cancer Center; 🇺🇸 Birmingham, Alabama, United States

St. Joseph's Hospital and Medical Center; 🇺🇸 Phoenix, Arizona, United States

Foundation for Cancer Research and Education; 🇺🇸 Phoenix, Arizona, United States

Mount Diablo Regional Cancer Center; 🇺🇸 Concord, California, United States

Sutter Cancer Center; 🇺🇸 Sacramento, California, United States

UCSF Comprehensive Cancer Center; 🇺🇸 San Francisco, California, United States

John Muir Comprehensive Cancer Center at John Muir Medical Center; 🇺🇸 Walnut Creek, California, United States

University of Colorado Cancer Center at University of Colorado Health Sciences Center; 🇺🇸 Aurora, Colorado, United States

Yale Comprehensive Cancer Center; 🇺🇸 New Haven, Connecticut, United States

Shands Cancer Center at the University of Florida Health Science Center; 🇺🇸 Gainesville, Florida, United States

Scroll for more (27 remaining)