Official websites use. Share sensitive information only on official, secure websites. Currently, it remains unclear, if patients with colon cancer and synchronous unresectable metastases who present without severe symptoms should undergo resection of the primary tumour prior to systemic chemotherapy.
Resection of the primary tumour may be associated with significant morbidity and delays the beginning of chemotherapy. However, it may prevent local symptoms and may, moreover, prolong survival as has been demonstrated in patients with metastatic renal cell carcinoma. It is the aim of the present randomised controlled trial to evaluate the efficacy of primary tumour resection prior to systemic chemotherapy to prolong survival in patients with newly diagnosed colon cancer who are not amenable to curative therapy.
Colon cancer patients with synchronous unresectable metastases are eligible for inclusion. Resection of the primary tumour as well as systemic chemotherapy is provided according to the standards of the participating institution. The primary endpoint is overall survival that is assessed with a minimum follow-up of 36 months.
Furthermore, it is the objective of the trial to assess the safety of both treatment strategies as well as quality of life. In Germany colorectal cancer represents the second most common malignancy among both sexes with a total annual incidence of The vast majority of these patients i. At present, the two principal treatment strategies for patients without severe tumour-related symptoms are: colonic resection followed by chemotherapy or immediate chemotherapy without prior surgery [ 5 ].
In theory, surgery delays the start of effective systemic therapy and bears the risk of severe complications and mortality. Surgery may, however, prevent development of complications caused by the primary tumour that may subsequently require emergency interventions that are associated with increased peri-operative mortality as well as less favourable long-term outcome.
