Chemoradiotherapy in Patients with Pancreatic Carcinoma: Phase-I Study with a Fixed Radiation Dose and Escalating Doses of Weekly Gemcitabine

Aim: The aim of this phase-I study is to determine the maximum tolerated dose (MTD) of weekly gemcitabine in concurrent combination with a total radiation dose of 54 Gy in patients with pancreatic cancer. Methods: In all patients, a total dose of 54 Gy was delivered in 30 fractions of 1.8 Gy/day. Gross tumor volume and regional lymph nodes were included in the irradiated volume with a 1- to 1.5-cm margin. The doses of weekly gemcitabine were escalated from 100 mg/m2 by increments of 50 mg/ m2 . Dose-limiting toxicity (DLT) was defined as hematologic toxicity, prolonged grade-3 non-hematologic toxicity, and incompletion of the planned treatment.Results: Twenty-six patients entered the trial. From level 1 (100 mg/m2 ) to level 4 (250 mg/m2 ), no patient experienced DLT except for 1 patient at level 1. At level 5 (300 mg/m2 ), 3 of the 5 patients met the DLT criteria. One patient developed severe pulmonary abscess, and the other 2 patients had hematologic DLT. The overall partial response rate was 29%, and the median survival time was 13.7 months. The first relapse occurred at the in-field primary site in 6 patients and at distant organs in 13 patients.Conclusion: The MTD of weekly gemcitabine was 250 mg/m2 in the present chemoradiotherapy setting. The efficacy of this chemoradiotherapy regimen is currently being evaluated in the phase-II setting.