title: The CAIRO4 study: the role of surgery of the primary tumour with few or absent symptoms in patients with synchronous unresectable metastases of colorectal cancer--a randomized phase III study of the Dutch Colorectal Cancer Group (DCCG).
abstract: BACKGROUND
  There is no consensus regarding resection of the primary tumour with few or absent symptoms in patients with synchronous unresectable metastatic colorectal cancer (CRC). A potential benefit of resection of the primary tumour is to prevent complications of the primary tumour in later stages of the disease. We here propose a randomized trial in order to demonstrate that resection of the primary tumour improves overall survival.
  
  
  METHODS
  The CAIRO4 study is a multicentre, randomized, phase III study of the Dutch Colorectal Cancer Group (DCCG). Patients with synchronous unresectable metastases of CRC and few or absent symptoms of the primary tumour are randomized 1:1 between systemic therapy only, and resection of the primary tumour followed by systemic therapy. Systemic therapy will consist of fluoropyrimidine-based chemotherapy in combination with bevacizumab. The primary objective of this study is to determine the clinical benefit in terms of overall survival of initial resection of the primary tumour. Secondary endpoints include progression free survival, surgical morbidity, quality of life and the number of patients requiring resection of the primary tumour in the control arm.
  
  
  CONCLUSIONS
  The CAIRO4 study is a multicentre, randomized, phase III study that will assess the benefit of resection of the primary tumour in patients with synchronous metastatic CRC.
  
  
  BACKGROUND
  The CAIRO4 study is registered at clinicaltrials.gov (NCT01606098).
authors.affiliation: Department of Surgery, Radboud university medical center, PO Box 9101, 6500 HB Nijmegen, The Netherlands. jorine.tlam-boer@radboudumc.nl.
authors.forename: Jorine
authors.initials: J
authors.lastname: 't Lam-Boer
authors.forename: Linda
authors.initials: L
authors.lastname: Mol
authors.forename: Cornelis
authors.initials: C
authors.lastname: Verhoef
authors.forename: Anton F J
authors.initials: AF
authors.lastname: de Haan
authors.forename: Mette
authors.initials: M
authors.lastname: Yilmaz
authors.forename: Cornelis J A
authors.initials: CJ
authors.lastname: Punt
authors.forename: Johannes H W
authors.initials: JH
authors.lastname: de Wilt
authors.forename: Miriam
authors.initials: M
authors.lastname: Koopman
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000068258:Bevacizumab; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000601:surgery*; D003131:Combined Modality Therapy / Q000379:methods*; D018572:Disease-Free Survival; D006801:Humans; D009362:Neoplasm Metastasis; D011788:Quality of Life; D016019:Survival Analysis
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000068258:Bevacizumab