原创力文档食管癌 Surgery alone vs. chemoradiotherapy followed by surgery for localized esophageal cancer analysis of a randomized controlled phase III trial FFCD 9901.pptVIP
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食管癌 Surgery alone vs. chemoradiotherapy followed by surgery for localized esophageal cancer analysis of a randomized controlled phase III trial FFCD 9901
* * * * * * * Surgery alone vs. chemoradiotherapy followed by surgery for localized esophageal cancer: analysis of a randomized controlled phase III trial FFCD 9901 C. Mariette, JF Seitz, E Maillard, F Mornex, PA Thomas, JL Raoul, V Boige, D Pezet, C Genet, L Bedenne French Federation of Digestive Oncology (FFCD) FRANCE Background Resection = the best treatment for resectable EC Local recurrence, distant metastasis and poor survival remain an issue after surgery In locally advanced EC (T3N+), neoadjuvant CRT Often investigated More and more evidence for survival benefit However impact of neoadjuvant CRT in small tumors is unknown Mariette et al. Lancet Oncol 2005 Mariette et al. Lancet Oncol 2007 Aim of the study To assess whether preoperative CRT improves outcomes for patients with localized (stages I or II) resectable esophageal carcinomas This study complied with the French and European Health guidelines on research involving human subjects Registred on clinicaltrials.gov NC Funding source: PHRC program from the French National Cancer Institute Methods Randomized controlled phase III trial 195 patients randomized by minimization from 06/2000 to 06/2009 30 centers in France Stratification: center, histology, cTNM stage, tumoral location Eligibility criteria resectable thoracic esophageal SCC or ADC cTNM stage I or II = T1N0/N+, T2N0/N+, T3N0 M0 (CT scan + EUS) 75 years old OMS status 0 or 1 Weight loss 15% Written consent form Study design Neoadjuvant CRT + surgery group (CRT+S group, n=97) 45Gy/25F/5 weeks with 2 courses of concomitant CT 5FU 800mg/m2/day D1-D4 + cisplatin 75mg/m2 D1 or D2 Surgery alone group (S group, n=98) Transthoracic approach with two-field lymphadenectomy R SURGERY SURGERY 5FU-Cis x 2 RT 45 Gy 4 to 6 weeks Endpoints Primary endpoint: Overall survival (time from randomization to all causes of death) Secondary endpoints: Disease free survival (events: first reccurrence, second cancer or all de
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