At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,044 enrolled
Drug / intervention
surgeryprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Clinical Trial Comparing Laparoscopic and Open Surgery for Rectal Cancer.
In Brief
A Phase 3 clinical trial evaluating surgery for Rectal Cancer. Completed, enrolled 1,044 participants across 35 sites in 9 countries.
Detailed Summary
COLOR II is a randomized, international, multi center study comparing the outcomes of laparoscopic and conventional resection of rectal carcinoma below 15 cm with curative intent. Clinical and operative data will be collected centrally in the coordinating centre in Halifax, Canada. Quality of life and costs will be assessed on a national basis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRectal Cancer
CountriesBelgium, Canada, Denmark, Germany, Netherlands, Poland, South Korea, Spain, Sweden
Collaborators--
Timeline
Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2004
First PostedMar 2006
Primary CompletionApr 2013
Study CompletionSep 2015
TodayJul 2026
First PostedMar 1, 2006
Enrollment StartJun 1, 2004
Primary CompletionApr 1, 2013
Study CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 8.8 yearsPosted 20.3 years ago
Interventions
surgeryprocedure
randomized to open or laparoscopic technique