title: Randomized phase II trial evaluating two paclitaxel and cisplatin-containing chemoradiation regimens as adjuvant therapy in resected gastric cancer (RTOG-0114).
abstract: OBJECTIVE
  The investigational arm of INT0116, a fluorouracil (FU) and leucovorin-containing chemoradiotherapy regimen, is a standard treatment for patients with resected gastric cancer with a 2-year disease-free survival rate (DFS) of 52%. Toxicity is also significant. More beneficial and safer regimens are needed.
  
  
  METHODS
  We performed a randomized phase II study among 39 cancer centers to evaluate two paclitaxel and cisplatin-containing regimens, one with FU (PCF) and the other without (PC) in patients with resected gastric cancer. Patients received two cycles of postoperative chemotherapy followed by 45 Gy of radiation with either concurrent FU and paclitaxel or paclitaxel and cisplatin. The primary objective was to show an improvement in 2-year DFS to 67% as compared with INT 0116.
  
  
  RESULTS
  From May 2001 to February 2004 (study closure), 78 patients entered this study, and 73 were evaluable. At the planned interim analysis of 22 patients on PCF, grade 3 or higher GI toxicity was 59%. This was significantly worse than INT0116, and this arm was closed. Accrual continued on PC. The median DFS was 14.6 months for PCF and has not been reached for PC. For PC the 2-year DFS is 52% (95% CI, 36% to 68%).
  
  
  CONCLUSIONS
  Though PC appears to be safe and the median DFS favorable, the DFS failed to exceed the lower bound of 52.9% for the targeted 67% DFS at 2 years and can not be recommended as the adjuvant arm for future randomized trials.
authors.affiliation: Memorial Sloan-Kettering Cancer Center, 1275 York Ave, New York, NY 10021, USA. schwartg@mskcc.org
authors.forename: Gary K
authors.initials: GK
authors.lastname: Schwartz
authors.forename: Kathryn
authors.initials: K
authors.lastname: Winter
authors.forename: Bruce D
authors.initials: BD
authors.lastname: Minsky
authors.forename: Christopher
authors.initials: C
authors.lastname: Crane
authors.forename: P John
authors.initials: PJ
authors.lastname: Thomson
authors.forename: Pramila
authors.initials: P
authors.lastname: Anne
authors.forename: Howard
authors.initials: H
authors.lastname: Gross
authors.forename: Christopher
authors.initials: C
authors.lastname: Willett
authors.forename: David
authors.initials: D
authors.lastname: Kelsen
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D005260:Female; D005500:Follow-Up Studies; D005743:Gastrectomy; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage; D011379:Prognosis; D012307:Risk Factors; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy* / Q000601:surgery; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D017239:Paclitaxel; D002945:Cisplatin