A Randomized Clinical Trial Comparing Laparoscopic and Open Surgery for Colon Cancer
18 Years
N/A
Both
Colonic Neoplasms
Trial Information
A Randomized Clinical Trial Comparing Laparoscopic and Open Surgery for Colon Cancer
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Primary endpoint is cancer free survival at three years.
Principal Investigator
Jaap Bonjer, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dalhousie University, CDHA / Erasmus MC Rotterdam
Authority:
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study ID:
COLOR I
NCT ID:
NCT00387842
Start Date:
March 1997
Completion Date:
March 2008
Related Keywords:
- Colonic Neoplasms
- Neoplasms
- Colonic Neoplasms
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