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Trial record 1 of 11 for:    ColoRectal Carcinoma Liver Transplantation
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Liver Transplantation and Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT01479608
Recruitment Status : Recruiting
First Posted : November 24, 2011
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Svein Dueland, Oslo University Hospital

Tracking Information
First Submitted Date  ICMJE November 22, 2011
First Posted Date  ICMJE November 24, 2011
Last Update Posted Date August 24, 2018
Actual Study Start Date  ICMJE April 11, 2012
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 4, 2014)
Overall survival [ Time Frame: 10 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 23, 2011)
Overall survival
Change History Complete list of historical versions of study NCT01479608 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Liver Transplantation and Colorectal Cancer
Official Title  ICMJE A Randomized Controlled Clinical Trial to Evaluate the Benefit and Efficacy of Liver Transplantation as Treatment for Selected Patients With Liver Metastases From ColoRectal Carcinoma
Brief Summary

Colorectal liver metastases (CLM) are currently considered an absolute contraindication for liver transplantation (Lt) although Lt for other primary and secondary liver malignancies show excellent outcome in selected patients. Before 1995, several Lts for CLM were performed, but the outcome was poor (18% 5-year survival) and Lt for CLM was stopped. Since then, several advances have been achieved and survival following Lt has improved by almost 30%. Thus, a 5-year survival of about 50% following Lt for CLM could be anticipated.

The investigators have previously included 21 patients in a pilot study. All patients had advanced CLM at the time of Lt. Long term overall survival (OS) exceeds by far previously reported outcome for this patient group and is comparable or better than survival following repeat Lt for non-malignant diagnoses. Development of robust selection criteria may further improve the results.

The investigators will conduct a randomized controlled trial to explore whether liver transplantation in selected patients with liver metastases from CRC can obtain significant life extension and better health related quality of life compared to patients receiving surgical resection.

The investigators will also explore if patient selection according to nomo-grams for outcome of colorectal cancer can define a subgroup of patients with a 5 year survival of at least 50% or even cure from the disease.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Colorectal Cancer
  • Liver Metastasis
Intervention  ICMJE Procedure: Liver transplantation and liver resection
Study Arms  ICMJE
  • Experimental: A: Transplantation or resection (randomized)
    Liver transplantation or liver resection by 1:1 randomization (open label)
    Intervention: Procedure: Liver transplantation and liver resection
  • Experimental: B: Liver transplantation
    For non-resectable patients metachronous disease.
    Intervention: Procedure: Liver transplantation and liver resection
  • Experimental: C:Liver transplantation
    For non-resectable patients synchronous disease.
    Intervention: Procedure: Liver transplantation and liver resection
Publications * Hagness M, Foss A, Line PD, Scholz T, Jørgensen PF, Fosby B, Boberg KM, Mathisen O, Gladhaug IP, Egge TS, Solberg S, Hausken J, Dueland S. Liver transplantation for nonresectable liver metastases from colorectal cancer. Ann Surg. 2013 May;257(5):800-6. doi: 10.1097/SLA.0b013e3182823957.

*   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: November 4, 2014)
25
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE December 2027
Estimated Primary Completion Date December 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically verified adenocarcinoma in colon or rectum.
  • No signs of extra hepatic metastatic disease or local recurrence according to PET/CT scan.
  • No signs of extra hepatic metastatic disease or local recurrence according to CT or MR (thorax/abdomen/pelvis) scan within 4 weeks prior to the faculty meeting at the transplant unit
  • No signs of local recurrence judged by colonoscopy / CT colography within 12 months prior to the faculty meeting at the transplant unit
  • Good performance status, ECOG 0 or 1.
  • Satisfactory blood tests Hb >10g/dl, neutrophiles >1.0 (after any G-CSF), TRC >75, Bilirubin<2 x upper normal level, ASAT,ALAT<5 x upper normal level, ,Creatinine <1.25 x upper normal level. Albumin above lower normal level.
  • Standard surgical procedure with adequate resection margins including circumferential resection margins (CRM) of at least ≥2mm for rectal cancer patients.
  • Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to GCP, and national/local regulations.
  • Received at least 3 cycles of chemotherapy (6 weeks of treatment), with no increase in size of the lesions according to RECIST-criteria

Additional inclusion criteria for patients included in part A:

- Six or more liver metastases technically resectable

Additional inclusion criteria for patients included in part B:

  • Metachronous liver metastases (more than 12 months from diagnosis of CRC and/or end of adjuvant treatment)
  • Pathological classification of primary tumor as pN0 disease.
  • CEA<100 ng/ml at time of primary diagnosis as well as at time of diagnosis of metastatic disease.
  • Liver metastases not eligible for curative liver resection.
  • Before start of 1. line chemotherapy, no lesion should be larger than 10 cm and total number of lesions should be 20 or less.
  • At least 10% response (RECIST-criteria) on 1. line chemotherapy. Patients must be accepted for transplantation before progressive disease on 1. line chemotherapy.

Additional inclusion criteria for patients included in part C:

  • Liver metastases not eligible for curative liver resection.
  • Received 1.line treatment.
  • Before start of 2. or 3. line chemotherapy, no lesion should be larger than 10 cm and total number of lesions should be 20 or less.
  • At least 10% response (RECIST-criteria) on 2. or 3. line chemotherapy. Patients must be accepted for transplantation before progressive disease on 2. or 3. line chemotherapy.
  • Two years or more time span from the CRC diagnosis and date of being listed on the transplantation list.

Exclusion Criteria:

  • Weight loss >10% the last 6 months
  • Patient BMI > 30
  • Other malignancies
  • Prior extra hepatic metastatic disease or local relapse.
  • Patients who have not received standard pre-operative, per-operative or post-operative treatment for the primary CRC.
  • Palliative resection of primary CRC tumor.
  • Previous randomization in this trial.
  • 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 and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Svein Dueland, MD 22934000 ext 47 svein.dueland@ous-hf.no
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01479608
Other Study ID Numbers  ICMJE SECA-II
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Svein Dueland, Oslo University Hospital
Study Sponsor  ICMJE Oslo University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Oslo University Hospital
Verification Date August 2018

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