Quality of life adjusted survival after palliative gastric resection plus chemotherapy or chemotherapy only in stage IV gastric cancer (QUADRIGA trial)

由于胃癌发病较晚，常常在晚期才被诊断出来，因此处于无法治愈的状态。许多试验报告，与最佳支持治疗相比，姑息化疗的总生存率和生活质量有所提高；然而，关于手术缓解的数据很少，而且通常没有考虑到生活质量。任何类型癌症的姑息治疗首先旨在保持或重建良好的生活质量，在胃癌的情况下，这种生活质量因无法进食或饮水而受损。理论上，这种情况下理想的治疗方法是手术切除原发肿瘤，以防止穿孔或出血，并通过切除狭窄迅速提高生活质量。考虑到目前胃手术的并发症发生率较低，因此单纯化疗可能不足以治疗IV期胃癌患者。本研究设计为多中心试验；愿意参加试验的原发性IV期胃腺癌患者将随机分为手术（胃切除后化疗）组或对照组（仅化疗）组。他们将被要求在干预前完成EORTC QLQ C-30和STO-22问卷调查，并在治疗开始后每月间隔一次。生活质量调整生存率将根据这些分数计算；生活质量、总住院时间、总生存期和并发症发生率将作为次要终点进行评估。

Due to the late onset of symptoms, gastric cancer is frequently diagnosed at an advanced stage and therefore in an incurable situation. A number of trials have reported an increase in overall survival and quality of life for palliative chemotherapy compared to best supportive care; data on surgical palliation, however, are scarce and generally do not take quality of life into account. Palliative therapy of any type of cancer firstly aims at preserving or re-establishing a good quality of life, which in the case of gastric cancer is impaired by the inability to eat or drink. Theoretically, the ideal treatment in this situation would be surgical resection of the primary tumour in order to prevent perforation or bleeding and to rapidly improve quality of life by removal of the stenosis. Taking into account the low complication rates of gastric surgery today, chemotherapy alone therefore may not be sufficient for stage IV gastric cancer patients. This study is designed as a multi-centre trial; patients with diagnosis of primary stage IV gastric adenocarcinoma who are willing to participate in the trial will be randomized to the surgical (gastric resection followed by chemotherapy) or the control (chemotherapy only) group. They will be asked to complete the EORTC QLQ C-30 and STO-22 questionnaires before intervention as well as in monthly intervals after start of treatment. Quality of life adjusted survival will be calculated based on these scores; quality of life, overall hospital stay, overall survival and complication rates will be assessed as secondary endpoints.