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

由于症状出现较晚，胃癌通常被诊断为晚期，因此处于无法治愈的境地。一些试验报告说，与最好的支持性治疗相比，姑息化疗的总体存活率和生活质量都有所提高；然而，关于外科姑息治疗的数据很少，而且通常没有考虑生活质量。姑息治疗任何类型的癌症，首先都是为了保持或重新建立良好的生活质量，对于胃癌来说，这种生活质量会因为不能进食或喝水而受到损害。从理论上讲，在这种情况下，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。考虑到今天胃手术的并发症发生率很低，因此对于IV期胃癌患者来说，单靠化疗可能是不够的。这项研究是一项多中心试验；愿意参加试验的被诊断为原发性IV期胃腺癌的患者将被随机分为手术组(胃切除后化疗)或对照组(仅化疗)。他们将被要求在干预前和治疗开始后每月一次完成EORTC QLQ C-30和STO-22问卷。生活质量调整后的存活率将根据这些得分计算；生活质量、总住院时间、总存活率和并发症发生率将被评估为次要终点。

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.