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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:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00030628
First received: February 14, 2002
Last updated: January 6, 2011
Last verified: September 2004
History of Changes
  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
Radiation: stereotactic radiosurgery
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: December 2001
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2 OR
  • Zubrod 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • At least 7 days since prior chemotherapy

Endocrine therapy:

  • Concurrent hormonal agents allowed
  • Concurrent steroids allowed

Radiotherapy:

  • See Disease Characteristics
  • No prior cranial radiotherapy

Surgery:

  • No prior resection of cerebral metastasis

Other:

  • Concurrent anticonvulsants allowed provided therapeutic serum/plasma level maintained before study intervention
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00030628

  Show 36 Study Locations
Sponsors and Collaborators
American College of Surgeons
National Cancer Institute (NCI)
Investigators
Study Chair: Anthony Asher, MD, FACS Carolina Neurosurgery and Spine Associates
  More Information

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

No publications provided

ClinicalTrials.gov Identifier: NCT00030628     History of Changes
Other Study ID Numbers: CDR0000069183, ACOSOG-Z0300
Study First Received: February 14, 2002
Last Updated: January 6, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
tumors metastatic to brain

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013