• Acta oncologica · May 2010

    Clinical Trial

    Capecitabine based postoperative accelerated chemoradiation of pancreatic carcinoma. A dose-escalation study.

    • Alessio G Morganti, Vincenzo Picardi, Edy Ippolito, Mariangela Massaccesi, Gabriella Macchia, Francesco Deodato, Gian Carlo Mattiucci, Luciana Caravatta, Liberato Di Lullo, Gianfranco Giglio, Rosa Tambaro, Samantha Mignogna, Paola Caprino, Marcello Ingrosso, Luigi Sofo, Numa Cellini, and Vincenzo Valentini.
    • Radiotherapy Unit, Department of Oncology, John Paul II Center for High Technology Research and Education in Biomedical Sciences, Catholic University, Campobasso, Italy.
    • Acta Oncol. 2010 May 1; 49 (4): 418-22.

    UnlabelledThe objective of this study was to evaluate the safety of escalating up to 55 Gy within five weeks, the dose of external beam radiotherapy to the previous tumor site concurrently with a fixed daily dose of capecitabine, in patients with resected pancreatic cancer.Material And MethodsPatients with resected pancreatic carcinoma were eligible for this study. Capecitabine was administered at a daily dose of 1600 mg/m (2). Regional lymph nodes received a total radiation dose of 45 Gy with 1.8 Gy per fractions. The starting radiation dose to the tumor bed was 50.0 Gy (2.0 Gy/fraction, 25 fractions). Escalation was achieved up to a total dose of 55.0 Gy by increasing the fraction size by 0.2 Gy (2.2 Gy/fraction), while keeping the duration of radiotherapy to five weeks (25 fractions). A concomitant boost technique was used. Dose limiting toxicity (DLT) was defined as any grade>3 hematologic toxicity, grade>2 liver, renal, neurologic, gastrointestinal, or skin toxicity, by RTOG criteria, or any toxicity producing prolonged (> 10 days) radiotherapy interruption.Results And DiscussionTwelve patients entered the study (median age: 64 years). In the first cohort (six patients), no patient experienced DLT. Similarly in the second cohort, no DLT occurred. All 12 patients completed the planned regimen of therapy. Nine patients experienced grade 1-2 nausea and/or vomiting. Grade 2 hematological toxicity occurred in four patients. The results of our study indicate that a total radiation dose up to 55.0 Gy/5 weeks can be safely administered to the tumor bed, concurrently with capecitabine (1600 mg/m (2)) in patients with resected pancreatic carcinoma.

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