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

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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.