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| ID | Type | Description | Link |
|---|---|---|---|
| PHRC/04-01 | |||
| CIC0203/030 |
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Stop recommended following the last sequential analysis
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | Simultaneous surgery of colorectal cancer and synchronous liver metastases |
|
| 2 | Other | Sequential surgeries of colorectal cancer and synchronous liver metastases |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simultaneous surgery | Procedure | Simultaneous surgery of colorectal cancer and synchronous liver metastases |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients with at least one postoperative severe complication within 60 days after each surgery | 60 days after each surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Non inclusion criteria:
Exclusion Criteria (at time of surgery)
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| Name | Affiliation | Role |
|---|---|---|
| Karim Boudjema, MD, PhD | Rennes University Hospital | Principal Investigator |
| Jean-Luc Raoul, MD | Centre Eugène Marquis - CRLCC Rennes | Principal Investigator |
| Eric Bellissant, MD, PhD | Rennes University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chirurgie générale viscérale et digestive - Hôpital Nord | Amiens | 80080 | France | |||
| Service de Chirurgie viscérale, digestive et cancérologie - Hôpital Jean Mingoz |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12892803 | Background | 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. | |
| 12905548 | 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. |
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| 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. |
|
| 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 |
| Two years recurrence rate | 2 years |
| Besançon |
| 25000 |
| France |
| Chirurgie digestive, thoracique et cancérologie | Dijon | 21000 | France |
| Département de Chirurgie - CRLCC Léon Bérard | Lyon | 69008 | France |
| Clinique Chirurgicale A - Hôtel Dieu | Nantes | 44093 | France |
| Clinique Chirurgicale I - Hôpital Nord | Nantes | 44093 | France |
| Centre de Chirurgie et Réanimation Digestives - Hôpital Saint Antoine | Paris | 75570 | France |
| Service de Chirurgie hépato-biliaire et Transplantation Hépatique- Paris Saint Antoine | Paris | France |
| Service de Chirurgie - Hôpital Jean Bernard | Poitiers | 86021 | France |
| Service d'Oncologie Digestive- CRLCC Eugène Marquis | Rennes | 35000 | France |
| Département de Chirurgie Viscérale - Hôpital Pontchaillou | Rennes | 35033 | France |
| Centre de Chirurgie Viscérale et de Transplantation - CHU de Hautepierre | Strasbourg | 67098 | France |
| Chirurgie Viscérale Digestive - CH Chubert | Vannes | 70555 | France |
| Centre Hépato-biliaire - Hôpital Paul Brousse | Villejuif | France |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D000096584 | Overlapping Surgery |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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