title: Phase II trial of preoperative chemoradiation in patients with localized gastric adenocarcinoma (RTOG 9904): quality of combined modality therapy and pathologic response.
abstract: OBJECTIVE
  Preoperative therapy for localized gastric cancer has considerable appeal. We hypothesized that, in a cooperative group setting, preoperative chemoradiotherapy would induce a 20% pathologic complete response (pathCR) rate. Combined-modality therapy quality, survival, and safety were secondary end points.
  
  
  METHODS
  Patients with localized gastric adenocarcinoma were eligible. A negative laparoscopic evaluation was required. Patients received two cycles of induction fluorouracil, leucovorin, and cisplatin followed by concurrent radiation and chemotherapy (infusional fluorouracil and weekly paclitaxel). Resection was attempted 5 to 6 weeks after chemoradiotherapy was completed. Quality of therapy was assessed with other end points.
  
  
  RESULTS
  Twenty institutions participated. Forty-nine patients were entered and 43 were assessable (12% stage IB; 37% stage II; and 52% stage III). The pathCR and R0 resection rates were 26% and 77%, respectively. At 1 year, more patients with pathCR (82%) are living than those with less than pathCR (69%). Grade 4 toxicity occurred in 21% of patients. Chemotherapy, radiotherapy, and surgery per protocol (including acceptable variations) occurred in 98%, 44%, and 63% of patients, respectively. A D2 dissection was performed in 50% of patients. Of 18 major radiotherapy variations, 17 were due to the lack of inclusion of the L3-4 vertebral interphase as prespecified.
  
  
  CONCLUSIONS
  For localized gastric cancer, preoperative chemoradiotherapy strategy achieved a pathCR rate of more than 20% in a cooperative group setting. The quality of surgery improved (50% with D2 dissection) possibly because surgery was part of this trial. With some refinements, this preoperative chemoradiotherapy strategy is poised for a randomized comparison with postoperative adjuvant chemoradiotherapy in patients with gastric cancer.
authors.affiliation: Department of Gastrointestinal Medical Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, TX 77030-4009, USA. Jajani@mdanderson.org
authors.forename: Jaffer A
authors.initials: JA
authors.lastname: Ajani
authors.forename: Kathryn
authors.initials: K
authors.lastname: Winter
authors.forename: Gordon S
authors.initials: GS
authors.lastname: Okawara
authors.forename: John H
authors.initials: JH
authors.lastname: Donohue
authors.forename: Peter W T
authors.initials: PW
authors.lastname: Pisters
authors.forename: Christopher H
authors.initials: CH
authors.lastname: Crane
authors.forename: John F
authors.initials: JF
authors.lastname: Greskovich
authors.forename: P Rani
authors.initials: PR
authors.lastname: Anne
authors.forename: Jeffrey D
authors.initials: JD
authors.lastname: Bradley
authors.forename: Christopher
authors.initials: C
authors.lastname: Willett
authors.forename: Tyvin A
authors.initials: TA
authors.lastname: Rich
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant / Q000009:adverse effects; D018572:Disease-Free Survival; D005260:Female; D005743:Gastrectomy / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000379:methods; D018714:Radiotherapy, Adjuvant / Q000009:adverse effects; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D016019:Survival Analysis; D016896:Treatment Outcome