Randomized phase II study of gemcitabine plus radiotherapy versus gemcitabine, 5-fluorouracil, and cisplatin followed by radiotherapy and 5-fluorouracil for patients with locally advanced, potentially resectable pancreatic adenocarcinoma

Purpose: A randomized phase II trial (E1200) was designed to assess toxicities and surgical resection rates in two neoadjuvant gemcitabine-based chemoradiation regimens in patients with borderline resectable pancreatic cancer. The trial was terminated early due to poor accrual. Patients and Methods: Patients with borderline resectable adenocarcinomas of the pancreas were enrolled. Arm A patients (n = 10) received gemcitabine 500 mg/m² IV weekly for 6 weeks, with radiation to 50.4 Gy followed by surgical resection. Arm B patients (n = 11) received preoperative gemcitabine 175 mg/m² on days 1, 5, 29, and 33, cisplatin 20 mg/m² on days 1-5 and 29-32, 5-FU 600 mg/m² on days 1-5 and 29-32, followed by radiation with continuous infusion 5-FU 225 mg/m² for 6 weeks. All patients received adjuvant gemcitabine 1,000 mg/m² weekly x 3 for five cycles. Results: Three patients in arm A, and two patients in arm B were resected. Hematologic toxicity was comparable between the two arms except more patients in arm B developed grade 3 or 4 thrombocytopenia than those in arm A. Arm B had fewer grade 1-2 GI toxicities although more patients (45%) experienced grade 3-4 GI toxicity. Conclusions: This phase II trial showed that both regimens were tolerable, and resectability and survival were comparable to previous studies.