Evaluation of 2 Resection Strategies of Synchronous Colorectal Cancer Metastases

NCT00264979 | Terminated DMC

• 3 other identifiers: DGS 2005/0193PHRC/04-01CIC0203/030
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 14

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.

Conditions

Colorectal Cancer; Hepatic Metastases

Keywords

Colorectal cancer; Sequential or simultaneous surgery; Synchronous hepatic metastases

Outcome Measures

Primary Outcomes (1)

• Rate of patients with at least one postoperative severe complication within 60 days after each surgery

  60 days after each surgery

Secondary Outcomes (6)

• Death rate during hospitalization or within 60 days after each surgery

  60 days after each surgery

• Rate and number of severe general, digestive or hepatic complications

  2 years after the first surgery

• Rate of unachieved hepatic resection

  Day of the hepatic surgery

• Global survival distribution and 2 years global survival rate

  2 years after the first surgery

• Recurrence-free survival distribution and 2 years recurrence-free survival rate

  2 years

Study Arms (2)

1

OTHER

Simultaneous surgery of colorectal cancer and synchronous liver metastases

Procedure: Simultaneous surgery

2

OTHER

Sequential surgeries of colorectal cancer and synchronous liver metastases

Procedure: Sequential surgery

Interventions

Simultaneous surgery PROCEDURE

Simultaneous surgery of colorectal cancer and synchronous liver metastases

1

Sequential surgery 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.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rennes University Hospital: lead
• Ministry of Health, France: collaborator

Study Sites (14)

Chirurgie générale viscérale et digestive - Hôpital Nord

Amiens, 80080, France

Location

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

Besançon, 25000, France

Location

Chirurgie digestive, thoracique et cancérologie

Dijon, 21000, France

Location

Département de Chirurgie - CRLCC Léon Bérard

Lyon, 69008, France

Location

Clinique Chirurgicale A - Hôtel Dieu

Nantes, 44093, France

Location

Clinique Chirurgicale I - Hôpital Nord

Nantes, 44093, France

Location

Centre de Chirurgie et Réanimation Digestives - Hôpital Saint Antoine

Paris, 75570, France

Location

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

Paris, France

Location

Service de Chirurgie - Hôpital Jean Bernard

Poitiers, 86021, France

Location

Service d'Oncologie Digestive- CRLCC Eugène Marquis

Rennes, 35000, France

Location

Département de Chirurgie Viscérale - Hôpital Pontchaillou

Rennes, 35033, France

Location

Centre de Chirurgie Viscérale et de Transplantation - CHU de Hautepierre

Strasbourg, 67098, France

Location

Chirurgie Viscérale Digestive - CH Chubert

Vannes, 70555, France

Location

Centre Hépato-biliaire - Hôpital Paul Brousse

Villejuif, France

Location

Related Publications (2)

• 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.

  PMID: 12892803 BACKGROUND

• 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.

  PMID: 12905548 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Overlapping Surgery

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Karim Boudjema, MD, PhD

  CHU Rennes

  PRINCIPAL INVESTIGATOR

• Jean-Luc Raoul, MD

  Centre Eugène Marquis - CRLCC Rennes

  PRINCIPAL INVESTIGATOR

• Eric Bellissant, MD, PhD

  CHU Rennes

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2005
• First Posted: December 13, 2005
• Study Start: March 2, 2006
• Primary Completion: December 11, 2017
• Study Completion: December 11, 2017
• Last Updated: March 11, 2019

Record last verified: 2019-03

Locations

FR (14)