Liver Transplantation Compared to Chemotherapy in Patients With ColoRectal Cancer (SECAIII)
|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: NCT03494946|
Recruitment Status : Recruiting
First Posted : April 11, 2018
Last Update Posted : April 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Liver Metastases Colorectal Cancer||Procedure: Liver transplantation Drug: Chemotherapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A randomized study were half of the subjects will be given standard chemo therapy and the other half will undergo liver transplantation.|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Clinical Trial Comparing Overall Survival in Selected Patients With ColoRectal Carcinoma Treated by Liver Transplantation or Chemotherapy|
|Actual Study Start Date :||December 5, 2016|
|Estimated Primary Completion Date :||January 2027|
|Estimated Study Completion Date :||January 2027|
Experimental: Arm A
Patients that suffer from Colorectal cancer and metastasis to liver that are randomized to Group A, will undergo Liver transplantation
Procedure: Liver transplantation
Active Comparator: Arm B
Patients that suffer from Colorectal cancer and metastasis to liver that are randomized to Group B, will be given chemotherapy, TACE, SIRT or other available treatment options.
May include chemotherapy, TACE, SIRT or other available treatment options.
Other Name: Other treatment
- Overall Survival [ Time Frame: 2 years from time of randomisation ]To determine overall survival after Ltx compared to palliative chemotherapy/other treatment in patients with progressive disease on chemotherapy or intolerance to 1-line chemotherapy.
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): NCT03494946
|Contact: Svein Dueland, PhDfirstname.lastname@example.org|
|Contact: Maria Gjerdeemail@example.com|
|Oslo University Hospital||Recruiting|
|Contact: Svein Dueland, PhD +4722934000 firstname.lastname@example.org|
|Contact: Maria Gjerde +4723070000 email@example.com|
|Principal Investigator:||Svein Dueland, PhD||Oslo University Hospital|