COlon Cancer Laparoscopic or Open Resection

Erasmus University

Status and phase

Unknown

Phase 3

Conditions

Colonic Neoplasms

Treatments

Procedure: Laparoscopic surgery

Procedure: Conventional surgery

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00387842

COLOR I

Details and patient eligibility

About

COLOR trial is a randomized, international, multi center study comparing the outcomes of laparoscopic and conventional resection of colon carcinoma with curative intent. Clinical and operative data will be collected centrally in the coordinating centre in Rotterdam, The Netherlands. Quality of life and costs will be assessed on a national basis.

Full description

The design involves allocation of all suitable consecutive patients with colon carcinoma to either of the two procedures at a randomization ratio of 1:1. The trial will be stratified according to participating centre, resection type and gender.

Disease free survival for all TNM stages after 3 years is currently about 70%. To detect a difference of 7% in disease free survival rate after 3 years between open and laparoscopic resection of colon cancer, 1200 patients will have to be included (60 vs 67%, two-sided analysis; alfa=0.05, beta=0.20, power=80% and p=0.05). All analyses will be performed on an intention to treat basis.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Solitary colon carcinoma observed at colonoscopy or on barium enema X-ray within 28-days before operation (no biopsy required)
Polyp containing invasive carcinoma according to colonoscopic biopsy, undertaken within 28 days before operation
Suitable for elective surgical resection by right hemicolectomy, left hemicolectomy or sigmoid resection
Sigmoid colon tumour cranially to conjugata diagonalis on lateral view of barium enema
BMI < 30 kg/m2
Informed consent according to local requirements

Exclusion criteria

Carcinoma of the splenic flexure
Carcinoma of the transverse colon
Signs of acute intestinal obstruction
More than one colon tumour
Scheduled need for other synchronous colon surgery
Synchronous surgery ofr other intra-abdominal organs
Pre-operative indication of invasion of adjacent organs
Pre-operative evidence of distant metastases
Previous ipsilateral colon surgery
Other malignancies in medical history, except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri
Absolute contra-indications to general anaesthesia or prolonged pneumoperitoneum, such as severe cardiovascular or respiratory disease
Pregnancy