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Status:

UNKNOWN

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

Lead Sponsor:

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Collaborating Sponsors:

Istituto Di Ricerche Farmacologiche Mario Negri

Gruppo Oncologico del Nord-Ovest

Conditions:

Liver Metastases

Colorectal Cancer Metastatic

Eligibility:

All Genders

18-69 years

Phase:

PHASE2

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

January 2 2019

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 1 2024

Estimated Enrollment :

22 Patients enrolled

Trial Details

Trial ID

NCT03803436

Start Date

January 2 2019

End Date

January 1 2024

Last Update

March 16 2023

Active Locations (12)

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Page 1 of 3 (12 locations)

1

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

Ancona, Italy

2

ASST Papa Giovanni XXIII

Bergamo, Italy, 24127

3

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

Genova, Italy

4

Fondazione IRCCS Istituto NAzionale Tumori di Milano

Milan, Italy, 20133