Phase I Trial of Simultaneous In-Field Boost With Helical Tomotherapy for Patients With One to Three Brain Metastases
- Department of Oncology, University of Western Ontario and London Regional Cancer Program, London Health Sciences Centre, London, ON (Canada)
- Department of Radiation Oncology, University of Ottawa, Ottawa, ON (Canada)
- Department of Human Oncology, University of Wisconsin, Madison, WI (United States)
Purpose: Stereotactic radiosurgery is an alternative to surgical resection for selected intracranial lesions. Integrated image-guided intensity-modulated-capable radiotherapy platforms such as helical tomotherapy (HT) could potentially replace traditional radiosurgery apparatus. The present study's objective was to determine the maximally tolerated dose of a simultaneous in-field boost integrated with whole brain radiotherapy for palliative treatment of patients with one to three brain metastases using HT. Methods and Materials: The inclusion/exclusion criteria and endpoints were consistent with the Radiation Therapy Oncology Group 9508 radiosurgery trial. The cohorts were constructed with a 3 + 3 design; however, additional patients were enrolled in the lower dose tolerable cohorts during the toxicity assessment periods. Whole brain radiotherapy (30 Gy in 10 fractions) was delivered with a 5-30-Gy (total lesion dose of 35-60 Gy in 10 fractions) simultaneous in-field boost delivered to the brain metastases. The maximally tolerated dose was determined by the frequency of neurologic Grade 3-5 National Cancer Institute Common Toxicity Criteria, version 3.0, dose-limiting toxicity events within each Phase I cohort. Results: A total of 48 patients received treatment in the 35-Gy (n = 3), 40-Gy (n = 16), 50-Gy (n = 15), 55-Gy (n = 8), and 60-Gy (n = 6) cohorts. No patients experienced dose-limiting toxicity events in any of the trial cohorts. The 3-month RECIST assessments available for 32 of the 48 patients demonstrated a complete response in 2, a partial response in 16, stable disease in 6, and progressive disease in 8 patients. Conclusion: The delivery of 60 Gy in 10 fractions to one to three brain metastases synchronously with 30 Gy whole brain radiotherapy was achieved without dose-limiting central nervous system toxicity as assessed 3 months after treatment. This approach is being tested in a Phase II efficacy trial.
- OSTI ID:
- 21587594
- Journal Information:
- International Journal of Radiation Oncology, Biology and Physics, Vol. 80, Issue 4; Other Information: DOI: 10.1016/j.ijrobp.2010.03.047; PII: S0360-3016(10)00605-X; Copyright (c) 2011 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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Related Subjects
BRAIN
CLINICAL TRIALS
COMPUTERIZED TOMOGRAPHY
CT-GUIDED RADIOTHERAPY
METASTASES
NEOPLASMS
RADIATION DOSES
SURGERY
TOXICITY
BODY
CENTRAL NERVOUS SYSTEM
DIAGNOSTIC TECHNIQUES
DISEASES
DOSES
MEDICINE
NERVOUS SYSTEM
NUCLEAR MEDICINE
ORGANS
RADIOLOGY
RADIOTHERAPY
TESTING
THERAPY
TOMOGRAPHY