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

AbstractPurposeA 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 MethodsPatients 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 × 3 for five cycles.ResultsThree 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.ConclusionsThis phase