Resection of the primary tumour versus no resection prior to systemic therapy in patients with colon cancer and synchronous unresectalbe metastases (UICC stage IV) - A randomised controlled multicentral trial

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The primary therapy for patients with colon cancer and synchronous metastases not amenable for curative therapy is systemic chemotherapy. It has, however, remained uncertain, if patients without symptomatic disease should undergo resection of the primary tumour prior to the beginning of chemotherapy. As colonic resection is associated with a known morbidity of 20-30% and mortality of up to 8% in these patients, indication for surgery in patients without marked symptoms needs to be justified by a relevant benefit in overall survival. Although data on metastatic renal cancer together with the results of the two largest non-randomized studies on patients with metastatic colorectal cancer suggest a potential benefit in overall survival for removal of the primary tumour, a randomised controlled trial in patients with colon cancer has not been performed yet. The SYNCHRONOUS Trial is a randomised controlled multicentre trial to investigate, whether resection of the primary tumour prolongs overall survival of patients with colon cancer and synchronous metastases not amenable for curative therapy. Progressionfree survival, time-to-treatment failure, time-to-development of tumour related local symptoms (control group), morbidity, mortality and quality of life will be assessed as secondary endpoints. Absence of a relevant survival benefit for patients undergoing colonic resection will have direct impact on current clinical practice and may, moreover, help to prevent procedure-related morbidity and mortality.