Phase I Study of Preoperative Short-Course Chemoradiation With Proton Beam Therapy and Capecitabine for Resectable Pancreatic Ductal Adenocarcinoma of the Head
- Department of Medical Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, MA (United States)
- Department of Radiation Oncology, Brigham and Womens' Hospital/Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA (United States)
- Department of Pathology, Massachusetts General Hospital, Harvard Medical School, Boston, MA (United States)
- Department of Radiation Oncology, Massachusetts General Hospital, Harvard Medical School, Boston, MA (United States)
- Department of Surgery, Massachusetts General Hospital, Harvard Medical School, Boston, MA (United States)
Purpose: To evaluate the safety of 1 week of chemoradiation with proton beam therapy and capecitabine followed by early surgery. Methods and Materials: Fifteen patients with localized resectable, pancreatic adenocarcinoma of the head were enrolled from May 2006 to September 2008. Patients received radiation with proton beam. In dose level 1, patients received 3 GyE x 10 (Week 1, Monday-Friday; Week 2, Monday-Friday). Patients in Dose Levels 2 to 4 received 5 GyE x 5 in progressively shortened schedules: level 2 (Week 1, Monday, Wednesday, and Friday; Week 2, Tuesday and Thursday), Level 3 (Week 1, Monday, Tuesday, Thursday, and Friday; Week 2, Monday), Level 4 (Week 1, Monday through Friday). Capecitabine was given as 825 mg/m{sup 2} b.i.d. Weeks 1 and 2 Monday through Friday for a total of 10 days in all dose levels. Surgery was performed 4 to 6 weeks after completion of chemotherapy for Dose Levels 1 to 3 and then after 1 to 3 weeks for Dose Level 4. Results: Three patients were treated at Dose Levels 1 to 3 and 6 patients at Dose Level 4, which was selected as the MTD. No dose limiting toxicities were observed. Grade 3 toxicity was noted in 4 patients (pain in 1; stent obstruction or infection in 3). Eleven patients underwent resection. Reasons for no resection were metastatic disease (3 patients) and unresectable tumor (1 patient). Mean postsurgical length of stay was 6 days (range, 5-10 days). No unexpected 30-day postoperative complications, including leak or obstruction, were found. Conclusions: Preoperative chemoradiation with 1 week of proton beam therapy and capecitabine followed by early surgery is feasible. A Phase II study is underway.
- OSTI ID:
- 21491549
- Journal Information:
- International Journal of Radiation Oncology, Biology and Physics, Vol. 79, Issue 1; Other Information: DOI: 10.1016/j.ijrobp.2009.10.061; PII: S0360-3016(09)03542-1; Copyright (c) 2011 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved.; ISSN 0360-3016
- Country of Publication:
- United States
- Language:
- English
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