Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00003354
Protocol/serial number
G9328312
Study information
Scientific title
Acronym
CLASICC
Study hypothesis
To determine whether disease-free and overall survival from laparoscopic surgery for colorectal cancer is comparable to that of conventional surgery as assessed by conventional end-points of survival and surrogate end-points of pathological findings
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Colorectal cancer
Intervention
Laparoscopic surgery vs conventional surgery
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Pathological endpoints (circumferential, longitudinal and high-tie mesenteric resection margins)
2. 30-day operative mortality
3. Disease-free survival, overall survival and local recurrence rates at 3 years
4. Local and distal recurrence rates, quality of life and cost effectiveness
Secondary outcome measures
1. Disease-free and overall survival at 5 years
2. Port-site and wound-site recurrence
3. Complication rates
4. Quality of life and cost effectiveness
5. Blood transfusion requirements
6. Loco-regional, anastomotic and distant metastases
Overall trial start date
01/07/1996
Overall trial end date
31/12/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Clinical diagnosis of colorectal cancer (unless this occurs in the transverse colon)
2. Suitable for elective surgical resection by right hemicolectomy, left hemicolectomy, sigmoid colectomy, anterior resection or abdomino-perineal resection
3. Aged >18 years
4. Give written informed consent
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
1000. Closed to recruitment - in follow-up
Participant exclusion criteria
1. Adenocarcinoma of the transverse colon
2. Any contraindication to pneumoperitoneum
3. Acute intestinal obstruction
4. Malignancy within previous 5 years (except basal cell carcinoma, in situ carcinoma of cervix or prostate cancer)
5. Synchronous multiple adenocarcinomas
6. If female, be pregnant
7. Associated gastrointestinal disease that requires surgical intervention
Recruitment start date
01/07/1996
Recruitment end date
31/12/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Academic Unit of Surgery
Leeds
LS9 7TF
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2005 short-term end points results in http://www.ncbi.nlm.nih.gov/pubmed/158940982
2. 2007 3 year results in http://www.ncbi.nlm.nih.gov/pubmed/17634484
3. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20013936
4. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20629110
Publication citations
-
Results
Taylor GW, Jayne DG, Brown SR, Thorpe H, Brown JM, Dewberry SC, Parker MC, Guillou PJ, Adhesions and incisional hernias following laparoscopic versus open surgery for colorectal cancer in the CLASICC trial., Br J Surg, 2010, 97, 1, 70-78, doi: 10.1002/bjs.6742.
-
Results
Jayne DG, Thorpe HC, Copeland J, Quirke P, Brown JM, Guillou PJ, Five-year follow-up of the Medical Research Council CLASICC trial of laparoscopically assisted versus open surgery for colorectal cancer., Br J Surg, 2010, 97, 11, 1638-1645, doi: 10.1002/bjs.7160.
-
Jayne DG, Guillou PJ, Thorpe H, Quirke P, Copeland J, Smith AM, Heath RM, Brown JM, , Randomized trial of laparoscopic-assisted resection of colorectal carcinoma: 3-year results of the UK MRC CLASICC Trial Group., J. Clin. Oncol., 2007, 25, 21, 3061-3068, doi: 10.1200/JCO.2006.09.7758.