Condition category
Cancer
Date applied
06/04/2000
Date assigned
06/04/2000
Last edited
02/12/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Professor PJ Guillou

ORCID ID

Contact details

Academic Unit of Surgery
Clinical Sciences Building
St James's University Hospital
Leeds
LS9 7TF
United Kingdom

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 measures

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

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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

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

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes