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

NCT03803436 | Unknown Phase 2

• 1 other identifier: INT 108/18
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 12

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

Conditions

Liver Metastases; Colorectal Cancer Metastatic; Liver Neoplasm; Neoplasms

Keywords

Liver Transplant; Colorectal Cancer; Chemotherapy; Metastasis

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Time from enrolement to either death or censoring

  5 years

Secondary Outcomes (2)

• Progression Free Survival

  5 years

• Complications rate

  90 days after liver transplant

Study Arms (2)

Study arm

EXPERIMENTAL

Liver transplant

Procedure: Liver transplant

Parallel arm

ACTIVE COMPARATOR

Chemotherapy

Drug: Chemotherapy

Interventions

Liver transplant PROCEDURE

Liver transplant from cadaveric donors

Study arm

Chemotherapy DRUG

mFOLFOX

Parallel arm

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead
• Istituto Di Ricerche Farmacologiche Mario Negri: collaborator
• Gruppo Oncologico del Nord-Ovest: collaborator

Study Sites (12)

SOD Clinica di Chirurgia Epatobiliare, Pancreatica e dei Trapianti e SC di Oncologia Medica, Ospedali Riuniti di Ancona

Ancona, Italy

NOT YET RECRUITING

ASST Papa Giovanni XXIII

Bergamo, 24127, Italy

NOT YET RECRUITING

Chirurgia EBP e dei Trapianti di Fegato e SC di Oncologia Medica, Ospedale Policlinico San Martino

Genova, Italy

NOT YET RECRUITING

Fondazione IRCCS Istituto NAzionale Tumori di Milano

Milan, 20133, Italy

RECRUITING

Ospedale Maggiore di Milano Policlinico

Milan, 20122, Italy

RECRUITING

Azienda Ospedaliera Ospedale Niguarda Ca' Granda

Milan, 20162, Italy

NOT YET RECRUITING

Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT)

Palermo, 90133, Italy

RECRUITING

GONO Group (Gruppo Oncologico Nord Ovest) TRIPLETE Trial Coordination

Pisa, Italy

RECRUITING

Fondazione Policlinico Universitario A.Gemelli IRCCS

Roma, Italy

NOT YET RECRUITING

Ospedale Universitario Molinette S. Giovanni Battista di Torino

Torino, 10126, Italy

RECRUITING

Centro Trapianti di Fegato e SC di Oncologia Medica, A.S.U. Integrata di Udine

Udine, Italy

NOT YET RECRUITING

Centro Trapianti di Fegato e SC di Oncologia Medica, A.O.U. Integrata di Verona

Verona, Italy

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 36822922 DERIVED

MeSH Terms

Conditions

Liver Neoplasms; Neoplasms; Colorectal Neoplasms; Neoplasm Metastasis

Interventions

Liver Transplantation; Drug Therapy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Digestive System Surgical Procedures; Surgical Procedures, Operative; Organ Transplantation; Transplantation

Study Officials

• Vincenzo Mazzaferro, MD, PhD

  Fondazione IRCCS Istituto Nazionale Tumori di Milano

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: January 14, 2019
• Study Start: January 2, 2019
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (12)