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)

Table 1 Investigation scheme in the SYNCHRONOUS trial

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⁾ 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

ISSN: 1471-2407