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Resection And Partial Liver Segmental Transplantation With Delayed Total Hepatectomy (RAPID-Padova)

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ClinicalTrials.gov Identifier: NCT04865471
Recruitment Status : Recruiting
First Posted : April 29, 2021
Last Update Posted : April 23, 2024
Sponsor:
Collaborator:
Istituto Oncologico Veneto IRCCS
Information provided by (Responsible Party):
Prof. Umberto Cillo, Azienda Ospedaliera di Padova

Tracking Information
First Submitted Date  ICMJE February 23, 2021
First Posted Date  ICMJE April 29, 2021
Last Update Posted Date April 23, 2024
Actual Study Start Date  ICMJE October 1, 2020
Estimated Primary Completion Date October 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 22, 2024)		 Percent of transplanted patients receiving second stage hepatectomy within 4 weeks of segment 2/3 transplantation [ Time Frame: within 4 weeks from liver transplantation ]
Rate of second stage hepatectomy performed within 4 weeks from transplatation
Original Primary Outcome Measures  ICMJE
 (submitted: April 28, 2021)		 Percent of transplanted patients receiving second stage hepatectomy within 4 weeks of segment 2/3 transplantation [ Time Frame: within 4 weeks from liver transplantation ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2024)
  • Intention to treat survival after liver transplantation [ Time Frame: 3 and 5 years ]
    Time from transplantation to either death or censoring
  • Progression free survival [ Time Frame: 3 and 5 years ]
    Time from enrolement to either progression or censoring
  • Proportion of drop out [ Time Frame: within 100 days from listing ]
    Rate of drop out from listing
  • Mortality [ Time Frame: within 90 days from second stage hepatectomy ]
    Rate of death within 90 days after second stage hepatectomy
  • Complication rate [ Time Frame: within 90 days after liver transplant ]
    Complications according to Dindo Clavien Classification
Original Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2021)
  • Intention to treat survival after liver transplantation [ Time Frame: 3 and 5 years ]
  • Progression free survival [ Time Frame: 3 and 5 years ]
  • Proportion of drop out [ Time Frame: within liver transplant ]
  • Mortality [ Time Frame: 90 days from second stage hepatectomy ]
  • Complication rate [ Time Frame: 90 days after liver transplant ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Resection And Partial Liver Segmental Transplantation With Delayed Total Hepatectomy
Official Title  ICMJE Resection And Partial Liver Segmental Transplantation With Delayed Total Hepatectomy as Treatment for Selected Patients With Unresectable Liver Metastases From Colorectal Carcinoma
Brief Summary RAPID is an auxiliary liver transplantation where a small liver partial graft (namely left lateral segments from living or cadaveric donors) is implanted orthotopically after a left hepatectomy of the native liver. Subsequently, in order to implement a fast regeneration of the transplanted segments a portal flow diversion is operated in the direction of the future remnant. After obtaining a fast regeneration of the auxiliary future remnant liver the native liver hepatectomy is completed as in a two stage- hepatectomy. Peculiar inclusion criteria will be adopted for patient selection with particular reference to the admission of patients with <3 lung metastases radically treated before transplantation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Liver Metastases
Intervention  ICMJE Procedure: Liver transplantation
Auxiliary liver transplantation and staged hepatectomy
Study Arms  ICMJE Experimental: Liver transplantation
Auxiliary liver transplantation and staged hepatectomy
Intervention: Procedure: Liver transplantation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 28, 2021)		 18
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2025
Estimated Primary Completion Date October 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ≥ 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
  • At least one line (3 months) of chemotherapy
  • At least 6 months time span from CRC resection and date of being listed on the transplantation list.
  • At least 8 weeks of tumor control: stable disease or partial response according to RECIST 1.1 criteria
  • No signs of extra hepatic metastatic disease or local recurrence on CT, MRI and Pet-CT except patients may have <3 lung lesions all<15mm resected or treated by radiotherapy or metastatic hilar nodes treated by resection and without recurrence at 3 months from resection or radiotherapy.
  • Satisfactory blood tests creatinine in normal level, PLT >60.000/mm3, GB>2500/mm3
  • CEA stable or in decrease
  • Signed informed consent and expected cooperation of the patients for the treatment and follow up

Exclusion Criteria:

  • Weight loss >10% the last 6 months
  • Patient BMI > 30
  • Participation refusal
  • General contraindication to LT
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Umberto Cillo, MD 049.8212211-1897 ext +39 cillo@unipd.it
Contact: Sara Lonardi, MD sara.lonardi@iov.veneto.it
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04865471
Other Study ID Numbers  ICMJE AOP1838
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Prof. Umberto Cillo, Azienda Ospedaliera di Padova
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Azienda Ospedaliera di Padova
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Istituto Oncologico Veneto IRCCS
Investigators  ICMJE Not Provided
PRS Account Azienda Ospedaliera di Padova
Verification Date April 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP