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Improving Outcome of Selected Patients With Non-resectable Hepatic Metastases From Colo-rectal Cancer With Liver Transplantation (COLT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03803436
Recruitment Status : Recruiting
First Posted : January 14, 2019
Last Update Posted : January 14, 2019
Sponsor:
Collaborators:
Istituto Di Ricerche Farmacologiche Mario Negri
Gruppo Oncologico del Nord-Ovest
Information provided by (Responsible Party):
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Liver Metastases Colorectal Cancer Metastatic Liver Neoplasm Neoplasms Procedure: Liver transplant Drug: Chemotherapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Outcome of Selected Patients With Non-resectable Hepatic Metastases From Colo-rectal Cancer With Liver Transplantation: a Prospective Parallel Trial
Actual Study Start Date : January 2, 2019
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study arm
Liver transplant
Procedure: Liver transplant
Liver transplant from cadaveric donors

Active Comparator: Parallel arm
Chemotherapy
Drug: Chemotherapy
mFOLFOX

Drug: Chemotherapy
Panitumumab




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 5 years ]
    Time from enrolement to either death or censoring


Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 5 years ]
    Time from enrolement to either progression or censoring

  2. Complications rate [ Time Frame: 90 days after liver transplant ]
    Complications according to Dindo Clavien Classification



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed non-mucinous colon adenocarcinoma.
  • Primary tumor as pT1-3, pN0 or pN1 (metastases in < 4 regional lymph nodes), confirmed R0 resection.
  • RAS and BRAF wild-type & MSS molecular status as per local testing.
  • Liver metastases not eligible for curative liver resection
  • Objective response according to RECIST 1.1 to first-line treatment, with sustained response for at least 4 months, OR disease control (CR+PR+SD) during second-line treatment for at least 4 months.
  • A maximum of two prior chemotherapy treatment lines.
  • Performance status, ECOG 0.
  • Satisfactory blood tests Hb >10g/dl, neutrophils >1.0 (after any G-CSF), TRC >75, Bilirubin<2 x upper normal level, AST, ALT<5 x upper normal level, creatinine <1.25 x upper normal level.
  • CEA<50 ng/ml

Exclusion Criteria:

  • Hereditary CRC syndromes including FAP and Lynch syndrome.
  • Prior extra hepatic metastatic disease or primary tumor local relapse.
  • Extra-peritoneal cancers (rectum).
  • Other malignancies in the previous 5 years
  • Active intra-venous or alcohol abusers
  • HIV infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03803436


Contacts
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Contact: Vincenzo Mazzaferro, MD, PhD +39 02 23902760 segreteria.mazzaferro@istitutotumori.mi.it
Contact: Carlo Sposito, MD +39 02 23903496 carlo.sposito@istitutotumori.mi.it

Locations
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Italy
SOD Clinica di Chirurgia Epatobiliare, Pancreatica e dei Trapianti e SC di Oncologia Medica, Ospedali Riuniti di Ancona Not yet recruiting
Ancona, Italy
Principal Investigator: Marco Vivarelli, MD         
ASST Papa Giovanni XXIII Not yet recruiting
Bergamo, Italy, 24127
Principal Investigator: Michele Colledan, MD         
Sub-Investigator: Domenico Pinelli, MD         
Chirurgia EBP e dei Trapianti di Fegato e SC di Oncologia Medica, Ospedale Policlinico San Martino Not yet recruiting
Genova, Italy
Principal Investigator: Enzo Andorno, MD         
Ospedale Maggiore di Milano Policlinico Recruiting
Milano, Italy, 20122
Principal Investigator: Giorgio Rossi, MD         
Sub-Investigator: Barbara Antonelli, MD         
Sub-Investigator: Paolo Reggiani, MD         
Azienda Ospedaliera Ospedale Niguarda Ca' Granda Not yet recruiting
Milano, Italy, 20162
Principal Investigator: Luciano De Carlis, MD         
Sub-Investigator: Andrea Sartore Bianchi, MD         
Sub-Investigator: Stefano Di Sandro, MD         
Fondazione IRCCS Istituto NAzionale Tumori di Milano Recruiting
Milan, Italy, 20133
Contact: Balbina Apice    +39 02 23902544    balbina.apice@istitutotumori.mi.it   
Sub-Investigator: Carlo Sposito, MD         
Sub-Investigator: Filippo Pietrantonio, MD         
Principal Investigator: Vincenzo Mazzaferro, MD, PhD         
Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT) Recruiting
Palermo, Italy, 90133
Principal Investigator: Salvatore Gruttadauria, MD         
Sub-Investigator: Duilio Pagano, MD         
GONO Group (Gruppo Oncologico Nord Ovest) TRIPLETE Trial Coordination Recruiting
Pisa, Italy
Principal Investigator: Alfredo Falcone, MD         
Sub-Investigator: Chiara Cremolini, MD         
Sub-Investigator: Carlotta Antoniotti, MD         
Fondazione Policlinico Universitario A.Gemelli IRCCS Not yet recruiting
Roma, Italy
Principal Investigator: Alfonso Avolio, MD         
Ospedale Universitario Molinette S. Giovanni Battista di Torino Recruiting
Torino, Italy, 10126
Principal Investigator: Renato Romagnoli, MD         
Centro Trapianti di Fegato e SC di Oncologia Medica, A.S.U. Integrata di Udine Not yet recruiting
Udine, Italy
Principal Investigator: Umberto Baccarani, MD         
Centro Trapianti di Fegato e SC di Oncologia Medica, A.O.U. Integrata di Verona Not yet recruiting
Verona, Italy
Principal Investigator: Umberto Tedeschi, MD         
Sub-Investigator: Paola Violi, MD         
Sub-Investigator: Amedeo Carraro, MD         
Sponsors and Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Istituto Di Ricerche Farmacologiche Mario Negri
Gruppo Oncologico del Nord-Ovest
Investigators
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Principal Investigator: Vincenzo Mazzaferro, MD, PhD Fondazione IRCCS Istituto Nazionale Tumori di Milano
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Responsible Party: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier: NCT03803436    
Other Study ID Numbers: INT 108/18
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: January 14, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano:
Liver Transplant
Colorectal Cancer
Chemotherapy
Metastasis
Additional relevant MeSH terms:
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Neoplasms
Colorectal Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases