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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00002708
First received: November 1, 1999
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether giving radiation therapy during surgery is more effective than standard radiation therapy in treating brain metastases.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without radiosurgery in treating patients with brain metastases that cannot be removed during surgery.


Condition Intervention Phase
Metastatic Cancer
Procedure: surgical procedure
Radiation: radiation therapy
Radiation: stereotactic radiosurgery
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A PHASE III TRIAL COMPARING WHOLE BRAIN IRRADIATION WITH VERSUS WITHOUT STEREOTACTIC RADIOSURGERY BOOST FOR PATIENTS WITH ONE TO THREE UNRESECTED BRAIN METASTASES

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Enrollment: 333
Study Start Date: January 1996
Study Completion Date: December 2004
Primary Completion Date: January 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Whole brain radiation therapy (WBRT) to 37.5 Gy/15 fractions/2.5 Gy once daily, 5 days/week followed by radiosurgery to all metastases
Procedure: surgical procedure Radiation: radiation therapy Radiation: stereotactic radiosurgery
Active Comparator: Arm 2
WBRT to 37.5 Gy/15 fractions/2.5 Gy once daily, 5 days/week
Radiation: radiation therapy

Detailed Description:

OBJECTIVES: I. Compare the overall survival of patients with one unresected brain metastasis treated with conventional whole brain radiotherapy (WBRT) with vs. without a stereotactic radiosurgery (SRS) boost. II. Compare sites of recurrence and cause of death in these patients treated with WBRT followed by SRS vs. WBRT alone.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center and extracranial disease (yes or no). Patients are randomized to one of two treatment arms. Arm I: Patients receive fractionated external beam whole brain irradiation (WBRT) 5 days each week for 3 weeks. Both portals are treated during each radiotherapy session. Patients who still have a solitary lesion with a diameter no greater than 4.0 cm also receive stereotactic radiosurgery within 7 days of completing WBRT. Arm II: Patients receive WBRT only. Patients are followed every 3 months for 1 year, then every 4 months for 2 years, and then annually.

PROJECTED ACCRUAL: A total of 262 patients will be accrued over 2.5-3.75 years for this study. The study may close early if interim analysis after 33% and 67% of patients have been followed for 6 months produces significant results. After 6/14/99 an additional 46 patients with a solitary brain metastasis only will be accrued.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: No more than 1 unresected or subtotally resected brain metastasis lesion from histologically confirmed systemic malignancy Eligible only if surgical resection refused by patient or resection deemed inappropriate by patient's physician 1 intraparenchymal metastasis clearly defined on contrast enhanced MRI Maximum diameter of lesion no greater than 4.0 cm No leukemia or lymphoma Extracranial sites of primary metastatic disease allowed if no clinical or radiographic evidence of progression within 1 month prior to entry No metastasis to brainstem, midbrain, pons, or medulla No leptomeningeal metastasis by MRI or CSF evaluation No metastasis within 10 mm of optic nerves and chiasm (area must be excluded from high dose stereotactic radiosurgery boost field)

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: 70-100% Karnofsky Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count at least 50,000/mm3 Hemoglobin at least 8 g/dL Hepatic: Not specified Renal: Not specified Other: Neurologic status 0-2 No major medical or psychiatric contraindication to protocol entry Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No concurrent chemotherapy for systemic cancer Endocrine therapy: Concurrent hormonal therapy, including tamoxifen, allowed Radiotherapy: No prior cranial radiotherapy Surgery: Prior subtotal resection allowed Other: No other concurrent treatment for brain metastasis until recurrence

  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: NCT00002708

  Show 258 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Study Chair: David W. Andrews, MD, FACS Kimmel Cancer Center (KCC)
  More Information

Additional Information:
Publications:
Sperduto PW, Scott C, Andrews D: Stereotactic radiosurgery with whole brain radiation therapy improves survival in patients with brain metastases: report of Radiation Therapy Oncology Group phase III study 95-08. [Abstract] Int J Radiat Oncol Biol Phys 54(2 suppl 1): 3, 2002.
Sperduto P, Scott C, Andrews D, et al.: Preliminary report of RTOG 95-08: a phase III trial comparing whole brain irradiation alone versus whole brain irradiation plus stereotactic radiosurgery for patients with two or three unresected brain metastases. [Abstract] Int J Radiat Oncol Biol Phys 48: A-6, 113, 2000.

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00002708     History of Changes
Other Study ID Numbers: RTOG-9508, CDR0000064522
Study First Received: November 1, 1999
Last Updated: November 18, 2013
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
tumors metastatic to brain

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

ClinicalTrials.gov processed this record on November 24, 2014