1172TiPConcurrent chemotherapy and external radiation therapy: An open label non-inferiority phase III randomized controlled trial of weekly versus three weekly cisplatin and radical radiotherapy in locally advanced head and neck squamous cell carcinoma: CONCERT trial

AbstractBackgroundLA-HNSCC is treated with concurrent chemo-radiation. Majority of guidelines recommend bolus Cisplatin in the dose of 100  mg/m2 (on days 1, 22, and 43). The meta-analysis reported by MACH-NC group found a greater benefit for platinum-based chemotherapy as compared with other protocols. Multiple studies back this notion. Other options are weekly cisplatin (30-40  mg/m2) or split course radiation and combination of DDP+5FU. Alternative dosing schedules (e.g., 30 to 40 mg/m2 weekly, 6 mg/m2 daily, or 20 mg/m2 daily for five days weeks 1 and 5) are used because of improved patient tolerance and ease of administration. 30 mg/m2 of weekly cisplatin has found to be inferior to 3 weekly 100 mg/m2. Three weekly schedules is the benchmark for further trials. In practice many of physicians alternatively, use low dose. 40 mg/m2 has been found superior to RT alone in a phase II randomized study. Whether 40 mg/m2 weekly cisplatin is inferior to 100  mg/m2 is not known. Based on our previous report and our long experience we are quite comfortable with weekly Cisplatin (in the dose of 40 mg/m2), and hypothesize that weekly Cisplatin (40  mg/m2) times 6-7 is non-inferior to 3 weekly Cisplatin 100  mg/m2 times three (days 1,22,43).Trial designMulticentric Open labelled, non-inferiority randomized controlled phase III trial. Sample size was calculated expecting 60% LRC (loco-regional control) rate at 2 years in control arm, and 65% in experimental arm...
Source: Annals of Oncology - Category: Cancer & Oncology Source Type: research