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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00030628
First received: February 14, 2002
Last updated: July 6, 2016
Last verified: July 2016
  Purpose

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.


Condition Intervention Phase
Metastatic Cancer
Radiation: radiation therapy
Procedure: surgery
Radiation: WBRT
Phase 3

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

Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Overall survival (OS) [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to CNS failure [ Time Frame: Up to 4 years ] [ Designated as safety issue: No ]
  • Change in QOL between SRS and SRS + WBRT treatment groups using the FACT-BR questionnaire [ Time Frame: From baseline to up to 3 months ] [ Designated as safety issue: No ]
  • Change in the duration of functional independence using the Barthel ADL Index score [ Time Frame: From baseline to up to 4 years ] [ Designated as safety issue: No ]

Enrollment: 480
Study Start Date: December 2001
Study Completion Date: October 2014
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: radiosurgery

Patients undergo radiosurgery.

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.

Radiation: radiation therapy Procedure: surgery
Experimental: radiosurgery + WBRT

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.

Radiation: radiation therapy Procedure: surgery Radiation: WBRT

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00030628

  Show 37 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Study Chair: Anthony Asher, MD, FACS Carolina Neurosurgery and Spine Associates
  More Information

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00030628     History of Changes
Other Study ID Numbers: ACOSOG-Z0300  CDR0000069183 
Study First Received: February 14, 2002
Last Updated: July 6, 2016
Health Authority: United States: Federal Government

Keywords provided by Alliance for Clinical Trials in Oncology:
tumors metastatic to brain

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes

ClinicalTrials.gov processed this record on December 09, 2016