Clinical trial · Interventional

COlon Cancer Laparoscopic or Open Resection

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

NCT00387842CI-TRIAL-00000480unknownPhase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Colonic Neoplasms	Colon Neoplasm	ALIAS	0.90

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Conventional surgery	Procedure	—	UNRESOLVED
Laparoscopic surgery	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (0)

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Primary outcomes (1)

measure
Primary endpoint is cancer free survival at three years.

Secondary outcomes (1)

measure
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.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (3)

DERIVEDKoedam 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. PMID 32224742
DERIVEDDeijen 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. PMID 27734203
DERIVEDColon Cancer Laparoscopic or Open Resection Study Group; Buunen M, Veldkamp R, Hop WC, Kuhry E, Jeekel J, Haglind E, Pahlman L, Cuesta MA, Msika S, Morino M, Lacy A, Bonjer HJ. Survival after laparoscopic surgery versus open surgery for colon cancer: long-term outcome of a randomised clinical trial. Lancet Oncol. 2009 Jan;10(1):44-52. doi: 10.1016/S1470-2045(08)70310-3. Epub 2008 Dec 13. PMID 19071061