COlon Cancer Laparoscopic or Open Resection

Colonic Neoplasms Clinical Trial

Official title:

A Randomized Clinical Trial Comparing Laparoscopic and Open Surgery for Colon Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00387842
• Other study ID #: COLOR I
• Status: Active, not recruiting
• Phase: Phase 3
• First received: October 12, 2006
• Last updated: October 12, 2006
• Start date: March 1997
• Est. completion date: March 2008

Study information

• Verified date: October 2006
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1200
• Est. completion date: March 2008
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colonic Neoplasms

Intervention

Procedure:
• Laparoscopic surgery

• Conventional surgery

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Erasmus Medical Center	Ethicon Endo-Surgery

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary endpoint is cancer free survival at three years.
Secondary	Secondary endpoints are overall survival at three and five years, 28 day mortality and morbidity, quality of life, costs, location and rates of recurrences and pathologic anatomic characteristics of the resected specimen.