A randomized controlled phase III comparing CF versus DCF versus CF-RT as neoadjuvant treatment for locally advanced esophageal cancer (JCOG1109, NExT study)

INTERVENTION: A: Two courses of preopeartive chemotherapy with cisplatin (80 mg/m2/day, day 1) and 5‐FU (800 mg/m2/day, day 1‐5) repeated every 3 weeks followed by surgery B: Three courses of preoperative chemotherapy with docetaxel (70 mg/m2/day, day 1), cisplatin (70 mg/m2/day, day1) and 5‐FU (750 mg/m2/day, day 1‐5) repeated every 3 weeks followed by surgery C: Two courses of preoperative chemoradiotherapy (41.4Gy/23fr) with cisplatin (75 mg/m2/day, day 1) and 5‐FU (1000 mg/m2/day, day 1‐4) repeated every 4 weeks followed by surgery CONDITION: clinical stage IB/II/III thoracic esophageal cancer PRIMARY OUTCOME: Overall Survival SECONDARY OUTCOME: Progression‐free survival, R0 resection rate, response rate, pathological complete response rate, adverse events during preoperative therapy, surgical morbidity, late toxicity, serious adverse events INCLUSION CRITERIA: 1) Histologically proven squamous cell carcinoma, adenosquamous carcinoma, or basaloid cell carcinoma 2) All lesion located in the thoracic esophagus 3) Clinical stage IB, II, III (excluding T4) based on the 7th UICC‐TNM classification 4) Aged 20 to 75 years old 5) ECOG performance status of 0 or 1 6) Measurable lesions not required 7) No prior therapy against esophageal cancer except for complete resection by EMR/ESD with either pT1a‐LPM(M2)/T1a‐MM(M3) disease or pT1a‐MM(M3) disease without vascular infiltration 8) No prior chemotherapy, radiotherapy or hormonal therapy against any cancers except for hormonal therapy for prostate cancer with more than 5 years of disease‐free interval 9) Adequate organ functions 10) R0 esophagectomy is judged as possible by open (or laparoscopic) thoracotomy and laparotomy 11) Written informed consent