title: 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.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  Patients with borderline resectable adenocarcinomas of the pancreas were enrolled. Arm A patients (n = 10) received gemcitabine 500 mg/m(2) 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/m(2) on days 1, 5, 29, and 33, cisplatin 20 mg/m(2) on days 1-5 and 29-32, 5-FU 600 mg/m(2) on days 1-5 and 29-32, followed by radiation with continuous infusion 5-FU 225 mg/m(2) for 6 weeks. All patients received adjuvant gemcitabine 1,000 mg/m(2) 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.
authors.affiliation: Department of Radiation Oncology, Emory University School of Medicine, Atlanta, Georgia 30322, USA. jerome@radonc.emory.org
authors.forename: Jerome
authors.initials: J
authors.lastname: Landry
authors.forename: Paul J
authors.initials: PJ
authors.lastname: Catalano
authors.forename: Charles
authors.initials: C
authors.lastname: Staley
authors.forename: Wayne
authors.initials: W
authors.lastname: Harris
authors.forename: John
authors.initials: J
authors.lastname: Hoffman
authors.forename: Mark
authors.initials: M
authors.lastname: Talamonti
authors.forename: Natalie
authors.initials: N
authors.lastname: Xu
authors.forename: Harry
authors.initials: H
authors.lastname: Cooper
authors.forename: Al B
authors.initials: AB
authors.lastname: Benson
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D011878:Radiotherapy / Q000009:adverse effects; D012449:Safety; D016019:Survival Analysis; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D002945:Cisplatin; D005472:Fluorouracil; D000093542:Gemcitabine
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