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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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