A Phase III Study of Conventional Radiation Therapy Plus Thalidomide Versus Conventional Radiation Therapy for Multiple Brain Metastases (RTOG 0118)
- Radiation Therapy Oncology Group, Philadelphia, PA (United States)
- Department of Radiation Oncology, Massachusetts General Hospital and Harvard Medical School, Boston, MA (United States)
- Department of Neuro-Oncology and Brain Tumor Center, University of Texas M.D. Anderson Cancer Center, Houston, TX (United States)
- Department of Radiation Oncology, Emory University, Atlanta, GA (United States)
- Department of Human Oncology, University of Wisconsin Medical School, Madison, WI (United States)
- Department of Radiation Oncology, Henry Ford Health System, Detroit, MI (United States)
- Department of Radiation Oncology, AZ Oncology Services and St. Joseph's Hospital, Phoenix, AZ (United States)
- University of Florida Proton Therapy Institute, Jacksonville, FL (United States)
- Department of Medicine, University of Wisconsin Medical School, Madison, WI (United States)
Purpose: To compare whole-brain radiation therapy (WBRT) with WBRT combined with thalidomide for patients with brain metastases not amenable to resection or radiosurgery. Patients and Methods: Patients with Zubrod performance status 0-1, MRI-documented multiple (>3), large (>4 cm), or midbrain brain metastases arising from a histopathologically confirmed extracranial primary tumor, and an anticipated survival of >8 weeks were randomized to receive WBRT to a dose of 37.5 Gy in 15 fractions with or without thalidomide during and after WBRT. Prerandomization stratification used Radiation Therapy Oncology Group (RTOG) Recursive Partitioning Analysis (RPA) Class and whether post-WBRT chemotherapy was planned. Endpoints included overall survival, progression-free survival, time to neurocognitive progression, the cause of death, toxicities, and quality of life. A protocol-planned interim analysis documented that the trial had an extremely low probability of ever showing a significant difference favoring the thalidomide arm given the results at the time of the analysis, and it was therefore closed on the basis of predefined statistical guidelines. Results: Enrolled in the study were 332 patients. Of 183 accrued patients, 93 were randomized to receive WBRT alone and 90 to WBRT and thalidomide. Median survival was 3.9 months for both arms. No novel toxicities were seen, but thalidomide was not well tolerated in this population. Forty-eight percent of patients discontinued thalidomide because of side effects. Conclusion: Thalidomide provided no survival benefit for patients with multiple, large, or midbrain metastases when combined with WBRT; nearly half the patients discontinued thalidomide due to side effects.
- OSTI ID:
- 21124185
- Journal Information:
- International Journal of Radiation Oncology, Biology and Physics, Vol. 71, Issue 1; Conference: 2007 interorganizational symposium on quality assurance of radiation therapy: Challenges of advanced technology, Dallas, TX (United States), 20-22 Feb 2007; Other Information: DOI: 10.1016/j.ijrobp.2007.09.016; PII: S0360-3016(07)04231-9; Copyright (c) 2008 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved; Country of input: International Atomic Energy Agency (IAEA); ISSN 0360-3016
- Country of Publication:
- United States
- Language:
- English
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