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

Study Protocol

Steffen P Luntz¹  Moritz Koch²  Ulrich Bork²  Markus W Büchler²  Jürgen Weitz³  Christine Fink⁴  Nuh N Rahbari⁵  Florian Lordick⁶  Stefan Englert⁷  Meinhard Kieser⁷  Dirk Jäger⁸  Annika Stange⁸  Inga Rossion⁹ 

[1] Coordination Centre for Clinical Trials (KKS), University Hospital Heidelberg, Heidelberg, Germany;Department of General, Visceral and Transplant Surgery, University of Heidelberg, Heidelberg, Germany;Department of General, Visceral and Transplant Surgery, University of Heidelberg, Heidelberg, Germany;Department of Surgery, University of Heidelberg, Im Neuenheimer Feld 110, 69120, Heidelberg, Germany;Department of General, Visceral and Transplant Surgery, University of Heidelberg, Heidelberg, Germany;Study Center of the German Surgical Society, University of Heidelberg, Heidelberg, Germany;Department of General, Visceral and Transplant Surgery, University of Heidelberg, Heidelberg, Germany;the SYNCHRONOUS trial group, Germany;Department of Hematology and Oncology, Klinikum Braunschweig, Braunschweig, Germany;Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany;National Center for Tumor Diseases (NCT), University of Heidelberg, Heidelberg, Germany;Study Center of the German Surgical Society, University of Heidelberg, Heidelberg, Germany;

关键词: Anastomotic Leakage;    Systemic Therapy;    Colonic Resection;    Primary Tumour Resection;    Synchronous Metastasis;   

DOI  :  10.1186/1471-2407-12-142

 received in 2012-01-23, accepted in 2012-04-05,  发布年份 2012

来源: Springer

【 摘 要 】

BackgroundCurrently, 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/designThe 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.DiscussionThe 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 registrationISRCTN30964555

【 授权许可】

Unknown   
© Rahbari et al; licensee BioMed Central Ltd. 2012. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.