## Protocol Section
### Identification Module
**NCT ID:** NCT00264979

**Acronym:** METASYNC

**Brief Title:** Evaluation of 2 Resection Strategies of Synchronous Colorectal Cancer Metastases

**Official Title:** Prospective Randomized Study Comparing the Morbidity and Mortality After Liver Resection for Synchronous Colorectal Cancer Metastases When Performed Either During or 12 to 14 Weeks After the Primary Resection

#### Organization Study ID Info
**ID:** DGS 2005/0193
#### Organization
**Class:** OTHER
**Full Name:** Rennes University Hospital
#### Secondary ID Infos
**ID:** PHRC/04-01
**ID:** CIC0203/030
### Status Module
#### Completion Date
**Date:** 2017-12-11

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-03-11

**Type:** ACTUAL

**Last Update Submit Date:** 2019-03-08

**Overall Status:** TERMINATED

#### Primary Completion Date
**Date:** 2017-12-11

**Type:** ACTUAL

#### Start Date
**Date:** 2006-03-02

**Type:** ACTUAL

**Status Verified Date:** 2019-03

#### Study First Post Date
**Date:** 2005-12-13
**Type:** ESTIMATED
**Study First Submit Date:** 2005-12-12
**Study First Submit QC Date:** 2005-12-12
**Why Stopped:** Stop recommended following the last sequential analysis
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER_GOV

**Name:** Ministry of Health, France

#### Lead Sponsor

**Class:** OTHER

**Name:** Rennes University Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**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 Module

**Conditions:**

- Colorectal Cancer

- Hepatic Metastases

**Keywords:**

- Colorectal cancer

- Sequential or simultaneous surgery

- Synchronous hepatic metastases

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 105

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Simultaneous surgery of colorectal cancer and synchronous liver metastases

**Intervention Names:**

- Procedure: Simultaneous surgery

**Label:** 1

**Type:** OTHER

#### Arm Group 2

**Description:** Sequential surgeries of colorectal cancer and synchronous liver metastases

**Intervention Names:**

- Procedure: Sequential surgery

**Label:** 2

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 1

**Description:** Simultaneous surgery of colorectal cancer and synchronous liver metastases

**Name:** Simultaneous surgery

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- 2

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

**Name:** Sequential surgery

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

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

**Time Frame:** 60 days after each surgery

#### Secondary Outcomes

**Measure:** Death rate during hospitalization or within 60 days after each surgery

**Time Frame:** 60 days after each surgery

**Measure:** Rate and number of severe general, digestive or hepatic complications

**Time Frame:** 2 years after the first surgery

**Measure:** Rate of unachieved hepatic resection

**Time Frame:** Day of the hepatic surgery

**Measure:** Global survival distribution and 2 years global survival rate

**Time Frame:** 2 years after the first surgery

**Measure:** Recurrence-free survival distribution and 2 years recurrence-free survival rate

**Time Frame:** 2 years

**Measure:** Two years recurrence rate

**Time Frame:** 2 years

### Eligibility Module

**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.

Non inclusion criteria:

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

Exclusion Criteria (at time of surgery)

* 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 Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Amiens

**Country:** France

**Facility:** Chirurgie générale viscérale et digestive - Hôpital Nord

**Zip:** 80080

**Location 2:**

**City:** Besancon

**Country:** France

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

**Zip:** 25000

**Location 3:**

**City:** Dijon

**Country:** France

**Facility:** Chirurgie digestive, thoracique et cancérologie

**Zip:** 21000

**Location 4:**

**City:** Lyon

**Country:** France

**Facility:** Département de Chirurgie - CRLCC Léon Bérard

**Zip:** 69008

**Location 5:**

**City:** Nantes

**Country:** France

**Facility:** Clinique Chirurgicale A - Hôtel Dieu

**Zip:** 44093

**Location 6:**

**City:** Nantes

**Country:** France

**Facility:** Clinique Chirurgicale I - Hôpital Nord

**Zip:** 44093

**Location 7:**

**City:** Paris

**Country:** France

**Facility:** Centre de Chirurgie et Réanimation Digestives - Hôpital Saint Antoine

**Zip:** 75570

**Location 8:**

**City:** Paris

**Country:** France

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

**Location 9:**

**City:** Poitiers

**Country:** France

**Facility:** Service de Chirurgie - Hôpital Jean Bernard

**Zip:** 86021

**Location 10:**

**City:** Rennes

**Country:** France

**Facility:** Service d'Oncologie Digestive- CRLCC Eugène Marquis

**Zip:** 35000

**Location 11:**

**City:** Rennes

**Country:** France

**Facility:** Département de Chirurgie Viscérale - Hôpital Pontchaillou

**Zip:** 35033

**Location 12:**

**City:** Strasbourg

**Country:** France

**Facility:** Centre de Chirurgie Viscérale et de Transplantation - CHU de Hautepierre

**Zip:** 67098

**Location 13:**

**City:** Vannes

**Country:** France

**Facility:** Chirurgie Viscérale Digestive - CH Chubert

**Zip:** 70555

**Location 14:**

**City:** Villejuif

**Country:** France

**Facility:** Centre Hépato-biliaire - Hôpital Paul Brousse

#### Overall Officials

**Official 1:**

**Affiliation:** CHU Rennes

**Name:** Karim Boudjema, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Centre Eugène Marquis - CRLCC Rennes

**Name:** Jean-Luc Raoul, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 3:**

**Affiliation:** CHU Rennes

**Name:** Eric Bellissant, MD, PhD

**Role:** STUDY_CHAIR

### References Module

#### References

**Citation:** 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

**Citation:** 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

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007414

- Term: Intestinal Neoplasms

- ID: D000005770

- Term: Gastrointestinal Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000003108

- Term: Colonic Diseases

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000012002

- Term: Rectal Diseases

- ID: D000009385

- Term: Neoplastic Processes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

### Condition Browse Module - Browse Leaves

- ID: M12307

- Name: Neoplasm Metastasis

- Relevance: HIGH

- As Found: Metastases

- ID: M17890

- Name: Colorectal Neoplasms

- Relevance: HIGH

- As Found: Colorectal Cancer

- ID: M10448

- Name: Intestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6336

- Name: Colonic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14844

- Name: Rectal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12330

- Name: Neoplastic Processes

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000015179

- Term: Colorectal Neoplasms

- ID: D000009362

- Term: Neoplasm Metastasis

### Intervention Browse Module - Browse Branches

- Abbrev: Hemat

- Name: Hematinics

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M11110

- Name: Liver Extracts

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
