Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
| Sanofi | INDUSTRY |
| Chugai Pharmaceutical | INDUSTRY |
Randomized, open label, multicentre phase II trial followed by phase III comparing overall survival after having selected the best experimental arm.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | FOLFIRI |
|
| B | Active Comparator | FOLFOX-4 |
|
| C | Experimental | FOLFIRI-HD |
|
| D | Experimental | FOLFOX-7 |
|
| E | Experimental | FOLFIRINOX |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FOLFIRI | Drug | FOLFIRI : Irinotecan : 180 mg/m² 90 min continuous perfusion during levorin d1 every 2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response | end of chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | during study treatment | |
| Survival | 2 years | |
| Secondary resection |
Not provided
Inclusion Criteria:
Exclusion Criteria:
-
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marc YCHOU, MD, PhD | CRLC Val d'Aurelle | Principal Investigator |
| Michel RIVOIRE, MD | CRLC Leon Berard - Lyon | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRLC Val d'Aurelle | Montpellier | 34298 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23955585 | Result | Ychou M, Rivoire M, Thezenas S, Quenet F, Delpero JR, Rebischung C, Letoublon C, Guimbaud R, Francois E, Ducreux M, Desseigne F, Fabre JM, Assenat E. A randomized phase II trial of three intensified chemotherapy regimens in first-line treatment of colorectal cancer patients with initially unresectable or not optimally resectable liver metastases. The METHEP trial. Ann Surg Oncol. 2013 Dec;20(13):4289-97. doi: 10.1245/s10434-013-3217-x. Epub 2013 Aug 17. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| C480833 | IFL protocol |
| C410216 | Folfox protocol |
| C000627770 | folfirinox |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| FOLFOX-4 | Drug | FOLFOX 4 : Oxaliplatine : 85 mg/m² 2h continuous perfusion during levorin d1 every 2weeks |
|
| FOLFIRI-HD | Drug | High Dose FOLFIRI : Irinotecan : 260 mg/m² in 90min continuous perfusion during levorin d1 every 2 weeks |
|
| FOLFOX-7 | Drug | FOLFOX 7 : Oxaliplatine : 130 mg/m² in 2h continuous perfusion during levorin d1 every 2 weeks |
|
| FOLFIRINOX | Drug | FOLFIRINOX : Oxaliplatine : 85 mg/m² 2h continuous perfusion followed by 1H rest followed by 90 min continuous perfusion of irinotecan : 180 mg/m² during levorin d1 every 2 weeks |
|
| surgery after chemotherapy |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |