INCAGI004

Randomized controlled trial comparing two neoadjuvant chemotherapy regimes for locally advanced rectal cancer. Stage II and III rectal cancer patients were randomized to receive neoCRT with either capecitabine (Group 1) or 5-Fu and leucovorin (Group 2) concomitant to long course radiotherapy. Clinical downstaging was accessed using MRI 6-8 weeks after treatment. EORTCs QLQ C30 and CR38 were applied before treatment (T0), after neoCRT (T1), after rectal resection (T2), early after adjuvant chemotherapy (T3), and one year after end of treatment or stoma closure (T4). Wexner scale was used for continence evaluation at T4. A C30SummaryScore (Geisinger et cols) was calculated to compare QOL results.本数据集为一项对比局部晚期直肠癌两种新辅助化疗方案的随机对照试验（Randomized Controlled Trial）。入组的Ⅱ期与Ⅲ期直肠癌患者被随机分配至两组：第1组接受卡培他滨（capecitabine）联合长程同步放疗的新辅助放化疗（neoCRT, neoadjuvant chemoradiotherapy），第2组接受5-氟尿嘧啶（5-Fu）与亚叶酸钙（leucovorin）联合长程同步放疗的新辅助放化疗方案。于治疗结束后6~8周通过磁共振成像（MRI）评估患者的临床降期情况。研究分别于治疗前（T0）、新辅助放化疗后（T1）、直肠切除术后（T2）、辅助化疗早期（T3）以及治疗结束或造口闭合后1年（T4）五个时间点，采用欧洲癌症研究与治疗组织（EORTC, European Organisation for Research and Treatment of Cancer）的QLQ-C30与CR38量表开展生活质量（Quality of Life, QOL）评价。在T4时间点采用韦克斯纳量表（Wexner scale）进行控便功能评估。本研究还计算了C30总结分（C30SummaryScore，源自Geisinger等学者的研究方法）以对比各组的生活质量结果。