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| Name | Class |
|---|---|
| Istituto Di Ricerche Farmacologiche Mario Negri | OTHER |
| Gruppo Oncologico del Nord-Ovest | OTHER |
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The COLT trial is an investigator-driven, multicenter, non-randomized, open-label, controlled, prospective, parallel trial, aimed at assessing the efficacy (in terms of overall survival: OS) of liver transplantation (LT) in liver-only CRC metastases, compared with a matched cohort of patients bearing the same tumor characteristics, collected during the same time period and included in a phase III Italian RCT on triplet chemotherapy+antiEGFR
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study arm | Experimental | Liver transplant |
|
| Parallel arm | Active Comparator | Chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liver transplant | Procedure | Liver transplant from cadaveric donors |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Time from enrolement to either death or censoring | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | Time from enrolement to either progression or censoring | 5 years |
| Complications rate | Complications according to Dindo Clavien Classification |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vincenzo Mazzaferro, MD, PhD | Contact | +39 02 23902760 | segreteria.mazzaferro@istitutotumori.mi.it | |
| Carlo Sposito, MD | Contact | +39 02 23903496 | carlo.sposito@istitutotumori.mi.it |
| Name | Affiliation | Role |
|---|---|---|
| Vincenzo Mazzaferro, MD, PhD | Fondazione IRCCS Istituto Nazionale Tumori di Milano | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SOD Clinica di Chirurgia Epatobiliare, Pancreatica e dei Trapianti e SC di Oncologia Medica, Ospedali Riuniti di Ancona | Not yet recruiting | Ancona | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36822922 | Derived | Sposito C, Pietrantonio F, Maspero M, Di Benedetto F, Vivarelli M, Tisone G, De Carlis L, Romagnoli R, Gruttadauria S, Colledan M, Agnes S, Ettorre G, Baccarani U, Torzilli G, Di Sandro S, Pinelli D, Caccamo L, Sartore Bianchi A, Spreafico C, Torri V, Mazzaferro V. Improving Outcome of Selected Patients With Non-Resectable Hepatic Metastases From Colorectal Cancer With Liver Transplantation: A Prospective Parallel Trial (COLT trial). Clin Colorectal Cancer. 2023 Jun;22(2):250-255. doi: 10.1016/j.clcc.2023.01.003. Epub 2023 Feb 3. |
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The study will compare survival in the population of patients enrolled in the COLT trial with the OS in the COLT-eligible population enrolled in the parallel TRIPLETE trial conducted by the GONO Group.
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| Chemotherapy |
| Drug |
mFOLFOX |
|
| Chemotherapy | Drug | Panitumumab |
|
| 90 days after liver transplant |
| ASST Papa Giovanni XXIII | Not yet recruiting | Bergamo | 24127 | Italy |
|
| Chirurgia EBP e dei Trapianti di Fegato e SC di Oncologia Medica, Ospedale Policlinico San Martino | Not yet recruiting | Genova | Italy |
|
| Fondazione IRCCS Istituto NAzionale Tumori di Milano | Recruiting | Milan | 20133 | Italy |
|
| Ospedale Maggiore di Milano Policlinico | Recruiting | Milan | 20122 | Italy |
|
| Azienda Ospedaliera Ospedale Niguarda Ca' Granda | Not yet recruiting | Milan | 20162 | Italy |
|
| Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT) | Recruiting | Palermo | 90133 | Italy |
|
| GONO Group (Gruppo Oncologico Nord Ovest) TRIPLETE Trial Coordination | Recruiting | Pisa | Italy |
|
| Fondazione Policlinico Universitario A.Gemelli IRCCS | Not yet recruiting | Roma | Italy |
|
| Ospedale Universitario Molinette S. Giovanni Battista di Torino | Recruiting | Torino | 10126 | Italy |
|
| Centro Trapianti di Fegato e SC di Oncologia Medica, A.S.U. Integrata di Udine | Not yet recruiting | Udine | Italy |
|
| Centro Trapianti di Fegato e SC di Oncologia Medica, A.O.U. Integrata di Verona | Not yet recruiting | Verona | Italy |
|
| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D009369 | Neoplasms |
| D015179 | Colorectal Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016031 | Liver Transplantation |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D016378 | Tissue Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D016377 | Organ Transplantation |
| D014180 | Transplantation |
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