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Open Access Study protocol

Resection of the primary tumour versus no resection prior to systemic therapy in patients with colon cancer and synchronous unresectable metastases (UICC stage IV): SYNCHRONOUS - a randomised controlled multicentre trial (ISRCTN30964555)

Nuh N Rahbari1, Florian Lordick2, Christine Fink13, Ulrich Bork1, Annika Stange4, Dirk Jäger4, Steffen P Luntz5, Stefan Englert6, Inga Rossion3, Moritz Koch1, Markus W Büchler1, Meinhard Kieser6, Jürgen Weitz17* and on behalf of the SYNCHRONOUS trial group

Author affiliations

1 Department of General, Visceral and Transplant Surgery, University of Heidelberg, Heidelberg, Germany

2 Department of Hematology and Oncology, Klinikum Braunschweig, Braunschweig, Germany

3 Study Center of the German Surgical Society, University of Heidelberg, Heidelberg, Germany

4 National Center for Tumor Diseases (NCT), University of Heidelberg, Heidelberg, Germany

5 Coordination Centre for Clinical Trials (KKS), University Hospital Heidelberg, Heidelberg, Germany

6 Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany

7 Department of Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany

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Citation and License

BMC Cancer 2012, 12:142  doi:10.1186/1471-2407-12-142

Published: 5 April 2012

Abstract

Background

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.

Methods/design

The SYNCHRONOUS trial is a multicentre, randomised, controlled, superiority trial with a two-group parallel design. Colon cancer patients with synchronous unresectable metastases are eligible for inclusion. Exclusion criteria are primary tumour-related symptoms, inability to tolerate surgery and/or systemic chemotherapy and history of another primary cancer. 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.

Discussion

The SYNCHRONOUS trial is a multicentre, randomised, controlled trial to assess the efficacy and safety of primary tumour resection before beginning of systemic chemotherapy in patients with metastatic colon cancer not amenable to curative therapy.

Trial registration

ISRCTN30964555