Improving Outcome of Selected Patients With Non-resectable Hepatic Metastases From Colo-rectal Cancer With Liver Transplantation
NCT ID: NCT03803436
Last Updated: 2023-03-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
22 participants
INTERVENTIONAL
2019-01-02
2024-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Study arm
Liver transplant
Liver transplant
Liver transplant from cadaveric donors
Parallel arm
Chemotherapy
Chemotherapy
mFOLFOX
Chemotherapy
Panitumumab
Interventions
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Liver transplant
Liver transplant from cadaveric donors
Chemotherapy
mFOLFOX
Chemotherapy
Panitumumab
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
69 Years
ALL
No
Sponsors
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Istituto Di Ricerche Farmacologiche Mario Negri
OTHER
Gruppo Oncologico del Nord-Ovest
OTHER
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
OTHER
Responsible Party
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Principal Investigators
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Vincenzo Mazzaferro, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Fondazione IRCCS Istituto Nazionale Tumori di Milano
Locations
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SOD Clinica di Chirurgia Epatobiliare, Pancreatica e dei Trapianti e SC di Oncologia Medica, Ospedali Riuniti di Ancona
Ancona, , Italy
ASST Papa Giovanni XXIII
Bergamo, , Italy
Chirurgia EBP e dei Trapianti di Fegato e SC di Oncologia Medica, Ospedale Policlinico San Martino
Genova, , Italy
Fondazione IRCCS Istituto NAzionale Tumori di Milano
Milan, , Italy
Ospedale Maggiore di Milano Policlinico
Milan, , Italy
Azienda Ospedaliera Ospedale Niguarda Ca' Granda
Milan, , Italy
Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT)
Palermo, , Italy
GONO Group (Gruppo Oncologico Nord Ovest) TRIPLETE Trial Coordination
Pisa, , Italy
Fondazione Policlinico Universitario A.Gemelli IRCCS
Roma, , Italy
Ospedale Universitario Molinette S. Giovanni Battista di Torino
Torino, , Italy
Centro Trapianti di Fegato e SC di Oncologia Medica, A.S.U. Integrata di Udine
Udine, , Italy
Centro Trapianti di Fegato e SC di Oncologia Medica, A.O.U. Integrata di Verona
Verona, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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INT 108/18
Identifier Type: -
Identifier Source: org_study_id
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