The Role of Surgery of the Primary Tumour in Patients With Synchronous Unresectable Metastases of Colorectal Cancer
NCT01606098
Interventional
Phase 3
Active, not recruiting
CAIRO4
The clinical benefit of resection of the primary tumour in patients with synchronous
unresectable metastases is not known. In the literature studies usually describe
retrospective selected patients with synchronous metastases treated with or without resection
of the primary tumour. All these studies are biased in patient selection and there are no
prospective randomized studies on this topic. In patients with few or absent symptoms of the
primary tumour, arguments both in favour and against initial resection have been presented,
and therefore a randomized trial is warranted. Although recent publications suggest that
resection of the primary tumour in synchronous metastasized colon cancer patients might not
be necessary, this appears to be based on feasibility and not on clinical outcome. Several
studies comparing large groups of patients with or without resection of the primary tumour
suggest an improved survival when the primary tumour is resected. A potential benefit of
resection of the primary tumour is to prevent complications of the primary tumour during
chemotherapy treatment or during later stages of the disease. A recent analysis of the CAIRO
and CAIRO2 data showed that metastatic colon cancer patients who had a resection of the
primary tumour prior to study entry, had an improved survival compared to patients without a
resection of the primary tumour. However, these patients were selected after the primary
tumour was resected and therefore these results are not corrected for surgical morbidity and
mortality. The investigators here propose a randomized trial in order to demonstrate that
resection of the primary tumour does improve overall survival.
Jul 31,2012
All
18 Years
N/A
18 Years
N/A
206