Abstract
Background: Both oxaliplatin/capecitabine-based chemoradiation (OXCAP-RT) and carboplatin-paclitaxel based radiation (CarPac-RT) are active regimens in oesophageal cancer, but no randomized study has compared their efficacy/toxicity. This study compares the two regimens to identify the optimum regimen to take forward to a phase III trial against neo-adjuvant chemotherapy, the current standard in the UK. Methods: Eligibility: Resectable adenocarcinoma of oesophagus and Type 1-2 Gastro-Osophageal Junction; ≥T3 and/or ≥N1 staged with EUS and PET-CT; PS 0-1. Intervention: Both arms receive 2 cycles induction OXCAP (oxaliplatin 130mg/m2 D1, Cape 625mg/m2 D1-21, q 3wk) followed by randomization to OXCAP-RT (oxali 85mg/m2 Day 1,15,29; cape 625mg/m2 on days of RT; RT-45Gy/25 fractions/5weeks) or CarPac-RT (Carbo AUC2 and paclitaxel 50mg/m2 Day 1,8,15,22,29; RT-45Gy/25 fractions/5weeks). Restaging CT/PET-CT 4-6 weeks after CRT, and 2-phase oesophagectomy with 2-field lymphadenectomy 6-8 weeks after CRT. Primary End-Point: Pathological complete response. Secondary: 1) Feasibility of recruitment; Toxicity; 30-day surgical morbidity/mortality; resection margin positivity rate; median, 3- and 5-yr OS. Statistics: Randomised phase II with 1:1 randomisation; planned accrual 76 patients (38/arm) over 18 months. In each arm, this sample size gives 90% power and one-sided type 1 error of 10% to detect that pCR is not 35%. Interim safety analysis: Toxicity analysis after 10 patients have completed treatment. RT Quality Assurance: Pre-trial: Detailed RT protocol and guidance document, RT workshop, central evaluation of test-case contours and adequacy of RT plan. On-trial: Real-time central review of contours and plans of first 20 patients on trial, 1st case from each centre, and 10% of cases selected at random.
Published Version
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