COlon Cancer Laparoscopic or Open Resection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-03-31

Study Completion Date

2008-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colonic Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Laparoscopic surgery

Intervention Type PROCEDURE

Conventional surgery

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jaap Bonjer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Dalhousie University, CDHA / Erasmus MC Rotterdam

References

Explore related publications, articles, or registry entries linked to this study.

Koedam TWA, Bootsma BT, Deijen CL, van de Brug T, Kazemier G, Cuesta MA, Furst A, Lacy AM, Haglind E, Tuynman JB, Daams F, Bonjer HJ; on behalf of the COLOR COLOR II study group. Oncological Outcomes After Anastomotic Leakage After Surgery for Colon or Rectal Cancer: Increased Risk of Local Recurrence. Ann Surg. 2022 Feb 1;275(2):e420-e427. doi: 10.1097/SLA.0000000000003889.

Reference Type DERIVED

PMID: 32224742 (View on PubMed)

Deijen CL, Vasmel JE, de Lange-de Klerk ESM, Cuesta MA, Coene PLO, Lange JF, Meijerink WJHJ, Jakimowicz JJ, Jeekel J, Kazemier G, Janssen IMC, Pahlman L, Haglind E, Bonjer HJ; COLOR (COlon cancer Laparoscopic or Open Resection) study group. Ten-year outcomes of a randomised trial of laparoscopic versus open surgery for colon cancer. Surg Endosc. 2017 Jun;31(6):2607-2615. doi: 10.1007/s00464-016-5270-6. Epub 2016 Oct 12.

Reference Type DERIVED

PMID: 27734203 (View on PubMed)