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Table 1 Investigation scheme in the SYNCHRONOUS trial

From: 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)

Documentation Visit 1 Visit 2 Visit 2a1) Visit 3 - 13 Visit 14
  Screening Maximum 2 weeks before start of therapy 30 days after surgery q 3 months after V2 36 months after V2
Eligibility criteria X     
Baseline data, demographics X     
Laboratory analyses X     
Tumor markers X    X X
Randomization   X    
Administered therapies    X X X
Chronic use of analgetic medication X    X X
Assessment of com-plications & safety    X X X
Primary endpoint    X X X
Secondary endpoints    X X X
Quality of life X    X 2) X
  1. 1) Visit 2a will be performed in patients allocated to the experimental arm only. 2) Quality of life will be assessed on V3 (3 months after V2), V4, (6 months) and then every 6 months