Health TrialsbyHealthPanel

LDLT in Non Resectable Colo-rectal Cancer Liver Metastasis

ConditionsColon AdenocarcinomaLiver Metastasis Colon Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-77
SponsorAzienda Ospedaliero-Universitaria di Modena

About this trial

This study is an interventional open label prospective study that aims to assess both overall and disease-free survival of patients treated with LDLT, partial or whole graft LT from deceased donors for unresectable CRLM.

Secondary outcomes are graft survival and donor outcomes in terms of safety and quality of life.

Donor selection is performed according to the currently used Institutional and National standards and protocols.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18.

Histologically confirmed colon and rectum (intraperitoneal) adenocarcinoma.

Pathological classification of primary tumor as pT1-3, without peritoneal tumor deposits, absence of mucinous component >50%, confirmed R0 resection, no limitations for RAS mutations, B-RAF wild type.

No signs of extra hepatic metastatic disease or local recurrence according to CT scan+MRI+PET/CT scans.

Disqualifiers

Hereditary CRC syndromes including FAP (Familial adenomatous polyposis) and Lynch syndrome.

Prior extra hepatic metastatic disease or primary tumor local relapse.

Palliative resection of primary CRC tumor.

Disease progression

Trial design

Design model

Single group

Treatments tested in this trial

  • Living donor liver transplant, Split liver transplant, RAPID, DDLT

    Procedure/Surgery

    Transplantation of part of the liver from a living donor, or entire cadaveric graft

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: LDLT, partial graft, whole graft recipientsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Overall survival

Overall survival of patients treated with LDLT for unresectable CRLM compared to our historical cohort of potentially transplantable patients that underwent chemotherapy only

Time frame
5 years
2

Disease free survival

Disease-free survival of patients treated with LDLT for unresectable CRLM compared to our historical cohort of potentially transplantable patients that underwent chemotherapy only

Time frame
5 years

Secondary outcomes

1

Graft survival

Incidence of retransplant in the LDLT group

Time frame
5 years
2

Donor quality of life

Measure of Health-related quality of life (HRQOL) of donors using the a Short Form Health Survey 36 (SF-36). SF-36 is a multiplanar scale with scores ranging from 0 to 100 where zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Azienda Ospedaliero-Universitaria di Modena

Lead sponsor

Source ClinicalTrials.gov
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