Colorectal Liver MetastasesMELODICNCT04870879
Colorectal Metastasis and Liver Transplantation With Organs From Deceased Donors
A study testing Liver Transplant and Chemotherapy in people with Colorectal Liver Metastases and Colorectal Adenocarcinoma, run by Azienda Ospedaliera di Padova at 1 site in Italy.
Trial summary
MELODIC trial is an prospective, multicenter, non-randomized, open-label, parallel trial, aimed at assessing the efficacy (in terms of overall survival: OS) of liver transplantation (LT) in unresecable CRC liver-only metastases, compared with a matched cohort of patients bearing the same tumor characteristics, and… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Colorectal Liver Metastases, Colorectal Adenocarcinoma, Unresectable Malignant Neoplasm
- What is being tested?
- Liver Transplant and Chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2020to Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 and <70 years
- Performance status, ECOG 0-1
- Histologically proved adenocarcinoma in colon or rectum.
- BRAF wild-type CRC on primary tumor or liver metastases
- High standard oncological surgical resection of the primary tumor
- Liver metastases not eligible for curative liver resection confirmed by the validation committee
Show all 15Show fewer
- At least one line (3 months) of chemotherapy
- No signs of extra hepatic metastatic disease or local recurrence on CT, MRI and Pet-CT within 4 weeks prior to the faculty meeting at the transplant unit
- Before start of chemotherapy no lesion should be larger than > 10 cm
- Objective response according to RECIST 1.1 or SD at two consecutive CT without CEA increase
- Patient with less than 10% response on chemotherapy may be included if they obtain al least 20% response after TACE (DEB-IRI) or by 90Y-spheres
- At least 10 months time span from CRC resection and date of being listed on the transplantation list.
- Satisfactory blood tests Hb >10g/dL, neutrophils >1.0, Bilirubin<2 x upper normal level, AST, ALT<5 x upper normal level, creatinine and albumin in normal level.
- CEA<100 ng/ml
- Signed informed consent and expected cooperation of the patients for the treatment and follow up
Who cannot join
- Weight loss >10% the last 6 months
- Patient BMI > 30
- Participation refusal
- General contraindication to LT
- Prior extra hepatic metastatic disease or primary tumor local relapse.
- Other malignancies in the previous 5 years
- Pregnancy or breast feeding
- Any reason why, in the opinion of the investigator, the patient should not participate.
Trial locations and contacts
1 site in 1 country.
Sara Lonardi, MD contact
Italy1 site, 1 recruiting
- Recruiting
U.O.C Chirurgia Epatobiliare e Trapianti Epatici, Azienda Ospedaliera di Padova
Padova, 35128
Umberto Cillo, MD, cillo@unipd.it
Umberto Cillo, MD
About this study
Official title: Colorectal Metastasis and Liver Transplantation With Organs From Deceased Donors: an Inductive Padova Center Protocol
MELODIC trial is an prospective, multicenter, non-randomized, open-label, parallel trial, aimed at assessing the efficacy (in terms of overall survival: OS) of liver transplantation (LT) in unresecable CRC liver-only metastases, compared with a matched cohort of patients bearing the same tumor characteristics, and treated with chemotherapy. Synthesis of Inclusion parameters: "10;10;10;100"
- Being tested
- Liver Transplant, Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver TransplantProcedure or surgery
Liver Transplant from cadaveric donors
ChemotherapyDrug
Chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Experimental | Liver transplant Receives: Procedure: Liver Transplant |
| Parallel arm | Other | Chemotherapy Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 3 years
Overall survival
Measured: 5 years
Secondary outcomes (3)
Progression free survival
Measured: 3 and 5 years
Proportion of drop out
Measured: within liver transplant
Complication rate
Measured: 90 days after liver transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start1 Oct 2020
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Liver MetastasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study will compared survival in patient enrolled in the MELODIC trial with the OS in a matched cohort of patients treated with chemotherapy
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera di Padova
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Oncologico Veneto IRCCS
- Responsible party
- Principal investigator, Prof. Umberto Cillo, Azienda Ospedaliera di Padova
- Investigators
- Umberto Cillo, MD, Principal investigator, U.O.C Chirurgia Epatobiliare e dei Trapianti Epatici, AOPD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04870879
- Sponsor's protocol ID
- AOP1840
- Acronym
- MELODIC
- Status last verified
- Apr 2021
- First submitted
- 23 Feb 2021
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colorectal Metastasis and Liver Transplantation With Organs From Deceased Donors: an Inductive Padova Center Protocol
- ClinicalTrials.gov ID
- NCT04870879
- Acronym / sponsor ID
- MELODIC / AOP1840
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera di PadovaUniversity, hospital or other
- Collaborators
- Istituto Oncologico Veneto IRCCS
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 4 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
MELODIC trial is an prospective, multicenter, non-randomized, open-label, parallel trial, aimed at assessing the efficacy (in terms of overall survival: OS) of liver transplantation (LT) in unresecable CRC liver-only metastases, compared with a matched cohort of patients bearing the same tumor characteristics, and treated with chemotherapy. Synthesis of Inclusion parameters: "10;10;10;100"
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study will compared survival in patient enrolled in the MELODIC trial with the OS in a matched cohort of patients treated with chemotherapy
| Arm | Type | Receives |
|---|---|---|
| Study arm | Experimental | Procedure: Liver TransplantLiver transplant |
| Parallel arm | Other | Drug: ChemotherapyChemotherapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- ≥ 18 and <70 years
- Performance status, ECOG 0-1
- Histologically proved adenocarcinoma in colon or rectum.
- BRAF wild-type CRC on primary tumor or liver metastases
- High standard oncological surgical resection of the primary tumor
Key exclusion criteria (8 listed)
- Weight loss >10% the last 6 months
- Patient BMI > 30
- Participation refusal
- General contraindication to LT
- Prior extra hepatic metastatic disease or primary tumor local relapse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liver TransplantLiver Transplant from cadaveric donors | Procedure or surgery | Study arm |
| ChemotherapyChemotherapy | Drug | Parallel arm |
Primary outcome
Overall survival
Time frame: 3 years
Overall survival
Time frame: 5 years
3 secondary outcomes
Progression free survival
Time frame: 3 and 5 years
Proportion of drop out
Time frame: within liver transplant
Complication rate
Time frame: 90 days after liver transplant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Lonardi, MD contact
Umberto Cillo, MD principal investigator
U.O.C Chirurgia Epatobiliare e dei Trapianti Epatici, AOPD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liver Transplant and Chemotherapy in people with Colorectal Liver Metastases and Colorectal Adenocarcinoma, run by Azienda Ospedaliera di Padova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Umberto Cillo, MD (049.8212211-1897, cillo@unipd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2021.