Evaluation of 2 Resection Strategies of Synchronous Colorectal Cancer Metastases

NCT ID: NCT00264979

Last Updated: 2019-03-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-02
• Study Completion Date: 2017-12-11

Brief Summary

The surgical strategy for the treatment of synchronous colorectal cancer liver metastases has not still been defined. The purpose of this study is to compare two treatment strategies in which liver resection is performed either during, or 12 to 14 weeks after the primary resection. Endpoints include the rate of severe complications and survival.

Detailed Description

In France, 35 000 colorectal cancers are diagnosed each year, 15 to 25% of which with hepatic metastases. It is nowadays admitted that the complete resection of these hepatic metastases represents the only treatment that has been shown to increase survival. The aim of this study is to evaluate the efficacy/safety ratio of the liver surgery when performed simultaneously or at distance of the primitive tumour ablation. Patients are randomized to undergo liver surgery either during, or 12 to 14 weeks after the primary resection. The primary endpoint is the rate of patients with at least one severe complication within 60 days after surgery. Secondary endpoints evaluate long-term clinical outcomes, in particular recurrence-free survival.

Conditions

Colorectal Cancer; Hepatic Metastases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Simultaneous surgery of colorectal cancer and synchronous liver metastases

Group Type: OTHER

Simultaneous surgery

Intervention Type: PROCEDURE

Simultaneous surgery of colorectal cancer and synchronous liver metastases

2

Sequential surgeries of colorectal cancer and synchronous liver metastases

Group Type: OTHER

Sequential surgery

Intervention Type: PROCEDURE

Sequential surgeries of colorectal cancer and synchronous liver metastases: the metastases surgery will be programmed 12 to 14 weeks after the primary tumour exeresis.

Interventions

Simultaneous surgery

Simultaneous surgery of colorectal cancer and synchronous liver metastases

Intervention Type: PROCEDURE

Sequential surgery

Sequential surgeries of colorectal cancer and synchronous liver metastases: the metastases surgery will be programmed 12 to 14 weeks after the primary tumour exeresis.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Male and female adults over 18 years old
• At least one adenocarcinoma of colon and/or rectum, histologically proven.
• No local complication at the time of surgery (no occlusion, no sub-occlusion, no massive hemorrhage, no abscesses or local invasion)
• At least one hepatic metastasis which R0 resection is possible through a conventional simple resection
• Informed written consent.

• Heart, Respiratory or Renal failure
• Physical or psychological dependence
• Chronic liver disease
• Extra-hepatic metastases

Exclusion Criteria

• Localized or diffuse peritoneal carcinomatosis
• Non resectable lymph node metastases
• Colorectal or hepatic tumour extension towards abdominal wall and/or adjacent organ making liver R0 resection impossible immediately
• Other hepatic lesions diagnosed with ultrasound making liver R0 resection impossible immediately

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health, France

OTHER_GOV

Sponsor Role: collaborator

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karim Boudjema, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Rennes

Jean-Luc Raoul, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Eugène Marquis - CRLCC Rennes

Eric Bellissant, MD, PhD

Role: STUDY_CHAIR

CHU Rennes

Locations

Chirurgie générale viscérale et digestive - Hôpital Nord

Amiens, , France

Service de Chirurgie viscérale, digestive et cancérologie - Hôpital Jean Mingoz

Besançon, , France

Chirurgie digestive, thoracique et cancérologie

Dijon, , France

Département de Chirurgie - CRLCC Léon Bérard

Lyon, , France

Clinique Chirurgicale A - Hôtel Dieu

Nantes, , France

Clinique Chirurgicale I - Hôpital Nord

Nantes, , France

Centre de Chirurgie et Réanimation Digestives - Hôpital Saint Antoine

Paris, , France

Service de Chirurgie hépato-biliaire et Transplantation Hépatique- Paris Saint Antoine

Paris, , France

Service de Chirurgie - Hôpital Jean Bernard

Poitiers, , France

Service d'Oncologie Digestive- CRLCC Eugène Marquis

Rennes, , France

Département de Chirurgie Viscérale - Hôpital Pontchaillou

Rennes, , France

Centre de Chirurgie Viscérale et de Transplantation - CHU de Hautepierre

Strasbourg, , France

Chirurgie Viscérale Digestive - CH Chubert

Vannes, , France

Centre Hépato-biliaire - Hôpital Paul Brousse

Villejuif, , France

Countries

France

References

Martin R, Paty P, Fong Y, Grace A, Cohen A, DeMatteo R, Jarnagin W, Blumgart L. Simultaneous liver and colorectal resections are safe for synchronous colorectal liver metastasis. J Am Coll Surg. 2003 Aug;197(2):233-41; discussion 241-2. doi: 10.1016/S1072-7515(03)00390-9.

Reference Type: BACKGROUND

PMID: 12892803 (View on PubMed)

Weber JC, Bachellier P, Oussoultzoglou E, Jaeck D. Simultaneous resection of colorectal primary tumour and synchronous liver metastases. Br J Surg. 2003 Aug;90(8):956-62. doi: 10.1002/bjs.4132.

Reference Type: BACKGROUND

PMID: 12905548 (View on PubMed)

Other Identifiers

PHRC/04-01

Identifier Type: -

Identifier Source: secondary_id

CIC0203/030

Identifier Type: -

Identifier Source: secondary_id

DGS 2005/0193

Identifier Type: -

Identifier Source: org_study_id