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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00030628
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 7, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Tracking Information
First Submitted Date  ICMJE February 14, 2002
First Posted Date  ICMJE January 27, 2003
Last Update Posted Date July 7, 2016
Study Start Date  ICMJE December 2001
Actual Primary Completion Date March 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2015)
Overall survival (OS) [ Time Frame: Up to 6 months ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2015)
  • Time to CNS failure [ Time Frame: Up to 4 years ]
  • Change in QOL between SRS and SRS + WBRT treatment groups using the FACT-BR questionnaire [ Time Frame: From baseline to up to 3 months ]
  • Change in the duration of functional independence using the Barthel ADL Index score [ Time Frame: From baseline to up to 4 years ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radiosurgery With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Cancer
Intervention  ICMJE
  • Radiation: radiation therapy
  • Procedure: surgery
  • Radiation: WBRT
Study Arms  ICMJE
  • 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.

    Interventions:
    • 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.

    Interventions:
    • Radiation: radiation therapy
    • Procedure: surgery
    • Radiation: WBRT
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 16, 2015)
480
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date March 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00030628
Other Study ID Numbers  ICMJE ACOSOG-Z0300
ACOSOG-Z0300
CDR0000069183 ( Other Identifier: NCI Physician Data Query )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alliance for Clinical Trials in Oncology
Study Sponsor  ICMJE Alliance for Clinical Trials in Oncology
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Anthony Asher, MD, FACS Carolina Neurosurgery and Spine Associates
PRS Account Alliance for Clinical Trials in Oncology
Verification Date July 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP