PuSH - Publication Server of Helmholtz Zentrum München

Rahbari, N.N.* ; Lordick, F.* ; Fink, C.* ; Bork, U.* ; Stange, A.* ; Jäger, D.* ; Luntz, S.P.* ; Englert, S.* ; Rossion, I.* ; Koch, M.* ; Büchler, M.W.* ; Kieser, M.* ; Weitz, J.*

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).

BMC Cancer 12:142 (2012)
DOI Order publishers version
Open Access Gold as soon as Publ. Version/Full Text is submitted to ZB.
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.
Altmetric
Additional Metrics?
Edit extra informations Login
Publication type Article: Journal article
Document type Scientific Article
ISSN (print) / ISBN 1471-2407
e-ISSN 1471-2407
Journal BMC Cancer
Quellenangaben Volume: 12, Issue: , Pages: , Article Number: 142 Supplement: ,
Publisher BioMed Central
Reviewing status Peer reviewed
Institute(s) Institute for Pancreatic Beta Cell Research (IPI)