An interim analysis of recruitment to the COLOFOL trial

Abstract

Objective: To analyse the ongoing process of recruiting patients into a multicenter randomized trial on follow-up after curative surgery for colorectal cancer. The trial is registered in Clinical Trials Registration.

Method: Prospective registration of all operated patients as well as inclusions (curative resection, stage II or III disease, <or= 75 years, clean colon and exclusions of the individual patients in eight participating departments.

Results: Between January 2006 and September 2007, 1309 patients have been operated upon. Of these 502 (38.3 %) met the inclusion criteria, 148 (29.5%) had exclusion criteria. Of the final eligible patients 241 (68.1%) were randomized. No specific barriers to inclusion were identified.

Conclusion: Of an overall population of patients operated for colorectal cancer about one in five were randomized. Bearing the rigorous inclusion and exclusion criteria in mind, this is considered satisfactory, and the investigated population may be representative of patients meeting the inclusion criteria.