Postoperative Intensity-Modulated Radiotherapy in Low-Risk Endometrial Cancers: Final Results of a Phase I Study
- Radiotherapy Unit, Department of Oncology, Catholic University, Campobasso (Italy)
- Physics Unit, 'John Paul II' Center for High Technology Research and Education in Biomedical Sciences, Catholic University, Campobasso (Italy)
- Gynecologic Oncology Unit, Department of Oncology, Catholic University, Campobasso (Italy)
- Department of Radiation Oncology, Lacks Cancer Center at Saint Mary's Health Care, Grand Rapids, MI (United States)
- Department of Radiotherapy, Policlinico A. Gemelli, Catholic University, Rome (Italy)
- Department of Obstetrics and Gynecology, Policlinico A. Gemelli, Catholic University, Rome (Italy)
Purpose: To determine the maximum tolerated dose of short-course radiotherapy (intensity-modulated radiotherapy technique) to the upper two thirds of the vagina in endometrial cancers with low risk of local recurrence. Patients and Methods: A Phase I clinical trial was performed. Eligible patients had low-risk resected primary endometrial adenocarcinomas. Radiotherapy was delivered in 5 fractions over 1 week. The planning target volume was the clinical target volume plus 5 mm. The clinical target volume was defined as the upper two thirds of the vagina as evidenced at CT simulation by a vaginal radio-opaque device. The planning target volume was irradiated by a seven-field intensity-modulated radiotherapy technique, planned by the Plato Sunrise inverse planning system. A first cohort of 6 patients received 25 Gy (5-Gy fractions), and a subsequent cohort received 30 Gy (6-Gy fractions). The Common Toxicity Criteria scale, version 3.0, was used to score toxicity. Results: Twelve patients with endometrial cancer were enrolled. Median age was 58 years (range, 49-74 years). Pathologic stage was IB (83.3%) and IC (16.7%). Median tumor size was 30 mm (range, 15-50 mm). All patients completed the prescribed radiotherapy. No patient experienced a dose-limiting toxicity at the first level, and the radiotherapy dose was escalated from 25 to 30 Gy. No patients at the second dose level experienced dose-limiting toxicity. The most common Grade 2 toxicity was gastrointestinal, which was tolerable and manageable. Conclusions: The maximum tolerated dose of short-course radiotherapy was 30 Gy at 6 Gy per fraction. On the basis of this result, we are conducting a Phase II study with radiotherapy delivered at 30 Gy.
- OSTI ID:
- 21372203
- Journal Information:
- International Journal of Radiation Oncology, Biology and Physics, Vol. 76, Issue 5; Other Information: DOI: 10.1016/j.ijrobp.2009.04.091; PII: S0360-3016(09)00858-X; Copyright (c) 2010 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved.; ISSN 0360-3016
- Country of Publication:
- United States
- Language:
- English
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