Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Radiation Therapy With or Without Radiosurgery 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: NCT00002708
Recruitment Status : Completed
First Posted : April 13, 2004
Last Update Posted : November 19, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Tracking Information
First Submitted Date  ICMJE November 1, 1999
First Posted Date  ICMJE April 13, 2004
Last Update Posted Date November 19, 2013
Study Start Date  ICMJE January 1996
Actual Primary Completion Date January 2002   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
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 Radiation Therapy With or Without Radiosurgery in Treating Patients With Brain Metastases
Official Title  ICMJE A PHASE III TRIAL COMPARING WHOLE BRAIN IRRADIATION WITH VERSUS WITHOUT STEREOTACTIC RADIOSURGERY BOOST FOR PATIENTS WITH ONE TO THREE UNRESECTED BRAIN METASTASES
Brief Summary

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.

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.

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
  • Procedure: surgical procedure
  • Radiation: radiation therapy
  • Radiation: stereotactic radiosurgery
Study Arms  ICMJE
  • 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
    Interventions:
    • 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
    Intervention: Radiation: radiation therapy
Publications *

*   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: November¬†18,¬†2013)
333
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE December 2004
Actual Primary Completion Date January 2002   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

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 Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00002708
Other Study ID Numbers  ICMJE RTOG-9508
CDR0000064522
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Radiation Therapy Oncology Group
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Radiation Therapy Oncology Group
Original Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: David W. Andrews, MD, FACS Sidney Kimmel Cancer Center at Thomas Jefferson University
PRS Account Radiation Therapy Oncology Group
Verification Date November 2013

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