ClinicalTrials.gov
ClinicalTrials.gov Menu

Liver Transplantation in Patients With Unresectable Colorectal Liver Metastases Treated by Chemotherapy (TRANSMET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02597348
Recruitment Status : Recruiting
First Posted : November 5, 2015
Last Update Posted : September 29, 2016
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
This is a multicentric randomized parallel group open trial comparing 5-year survival of chemotherapy followed by LT (Group LT+C) versus chemotherapy alone (Group C) in patients with confirmed unresectable liver-only metastases, well controlled by chemotherapy (no progression) and extensively explored by modern imaging techniques. The primary objective of the trial is to validate in a large multicentric cohort of selected patients the possibility to obtain at least 50% 5-years survival with LT combined to chemotherapy compared to around 10% with chemotherapy alone.

Condition or disease Intervention/treatment Phase
Liver Metastasis Colorectal Cancer Metastasis Procedure: Liver Transplantation Phase 3

Detailed Description:

Liver transplantation (LT) has recently been proposed as alternative treatment for definitively unresectable colorectal liver metastases in selected patients with a 60% estimated survival at 5 years in a recent prospective Norwegian study. However, disease free survival (DFS) in this preliminary study has been poor with 90% of recurrence after LT.

The objective of our study is to validate LT as a therapeutic option on a large multicentric scale throughout a highly strict policy selection in term of survival, disease free survival and quality of life. In order to reduce selection bias, unresectability criteria and theorical indication to LT will be confirmed by an independent Steering Committee including HPB surgeons, oncologists, radiologists and hepatologists.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Curative Potential of Liver Transplantation in Patients With Definitively Unresectable Colorectal Liver Metastases (CLM) Treated by Chemotherapy: a Prospective Multicentric Randomized Trial
Study Start Date : September 2015
Estimated Primary Completion Date : February 2027
Estimated Study Completion Date : February 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Liver Transplantation
Arm LT+C: patients will be treated by experimental liver transplantation preceding the non experimental standard chemotherapy (according to usual practices).
Procedure: Liver Transplantation
The patient of the arm LT+C are treated by experimental liver transplantation preceding the Non experimental standard chemotherapy (according to usual practices) .
Other Name: Experimental LT+Non Experimental Usual Chimiotherapy

No Intervention: No intervention
Arm C: patients will receive non experimental standard chemotherapy according to usual practices in the context of definitively unresectable CLM.



Primary Outcome Measures :
  1. 5 years overall survival (OS) [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. 3-years overall survival (OS) [ Time Frame: 3 years ]
  2. Disease free survival (DFS) (Arm LT+C) or Progression free survival (PFS) (Arm C) [ Time Frame: 3 and 5 years ]
  3. Recurrence rate at 3 and 5 years [ Time Frame: 3 and 5 years ]
    Radiological assessment will be performed according to the RECIST criteria and confirmed by 2 local radiologists.

  4. Quality of life (QOL) of patients using the European Organization for Research and Treatment of Cancer (EORTC) questionnaires.: QLQ-C30 [ Time Frame: year 5 ]
    QLQ-C30 covers general aspects of health-related quality of life

  5. Quality of life (QOL) of patients using the European Organization for Research and Treatment of Cancer (EORTC) questionnaires.: QLQ-LMC21 [ Time Frame: year 5 ]
    QLQ-LMC21 is valid and reliable questionnaire module to use with the QLQ-C30 in assessing in hepatectomy or palliative treatment for colorectal liver metastases

  6. Quality of life (QOL) of patients of Group LT followed by chemotherapy, using the NIDDK questionnaire of Liver Transplantation Database [ Time Frame: year 5 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 18 and ≤ 65 years
  • Good performance status, ECOG 0 or 1 (39).
  • 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 defined by :

    • Safe margin of resection
    • Curative resection of primary tumor according to oncological principles
    • TNM adequate staging
  • Absence of local recurrence on colonoscopy (within 12 months before inclusion)
  • Confirmed non resectable colorectal liver metastases by the validation committee
  • ≥ 3 months of tumor control during the last chemotherapy line: Stable or Partial Response on RECIST criteria (40)
  • ≤ 2 lines of chemotherapy for metastatic disease
  • CEA < 80 microg/L or a decrease ≥ 50% of the highest serum CEA levels observed during the disease
  • Absence of extrahepatic tumor localisation according to CT scan and PET-CT
  • Renal function should be within the normal limits
  • No need for extra-renal purification procedure, hemodialysis or kidney transplantation associated (nephrologist assessment)
  • A platelet count> 80,000 / mm3
  • White blood cell count> 2500 / mm3
  • Eligible for both treatments groups
  • Signed informed consent and expected cooperation of the patient for the treatment and follow up

Exclusion Criteria:

  • Participation refusal
  • No health insurance facilities
  • General contraindication to LT (Severe cardiopulmonary disease or other life-limiting coexisting medical conditions, extrahepatic malignancy, active alcohol or substance abuse, active infection or uncontrolled sepsis, lack of psychosocial support or inability to comply with medical treatment)
  • Other malignancies either concomitant or within 5 years before liver transplantation
  • Patients not having received standard treatment for the primary CRC according to recommended guidelines
  • Prior extra hepatic metastatic disease or local relapse
  • Pregnancy at the time of inclusion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02597348


Contacts
Contact: René ADAM, PhD +33 (0) 1 45 59 30 49 rene.adam@aphp.fr

Locations
France
AP-HP, Paul Brousse Hospital Recruiting
Villejuif, France, 94800
Contact: René ADAM, PhD    +33 (0) 1 45 59 30 49    rene.adam@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: René ADAM, PhD AP-HP, Paul Brousse Hospital

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02597348     History of Changes
Other Study ID Numbers: P130922
First Posted: November 5, 2015    Key Record Dates
Last Update Posted: September 29, 2016
Last Verified: September 2016

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Liver
Metastasis
Colorectal cancer
Liver transplantation

Additional relevant MeSH terms:
Liver Neoplasms
Liver Diseases
Liver Extracts
Colorectal Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Hematinics