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

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Status and phase: Enrolling; Phase 2

Conditions: Neoplasms; Liver Neoplasm; Liver Metastases; Colorectal Cancer Metastatic

Treatments: Procedure: Liver transplant; Drug: Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03803436

INT 108/18

Details and patient eligibility

About

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

Enrollment: 22 estimated patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Study arm

Experimental group

Description:

Liver transplant

Treatment:

Procedure: Liver transplant

Parallel arm

Active Comparator group

Description:

Chemotherapy

Treatment:

Drug: Chemotherapy

Drug: Chemotherapy