COLLISION Trial - Colorectal Liver Metastases: Surgery vs Thermal Ablation (COLLISION)
|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: NCT03088150|
Recruitment Status : Recruiting
First Posted : March 23, 2017
Last Update Posted : August 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|ColoRectal Cancer Liver Metastasis Colon Cancer Liver Metastases Surgery||Procedure: Thermal ablation Procedure: Surgical resection||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||618 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||COLLISION Trial - Colorectal Liver Metastases: Surgery vs Thermal Ablation, a Phase III Single-blind Prospective Randomized Controlled Trial|
|Actual Study Start Date :||July 13, 2017|
|Estimated Primary Completion Date :||July 2022|
|Estimated Study Completion Date :||December 2022|
Active Comparator: Surgical resection
Patients included will undergo resection of hepatic metastases, allowing thermal ablation for additional unresectable lesions.
Procedure: Surgical resection
In case of randomization to surgical resection, the surgeon will remove all target lesions as well as all additional unablatable lesions.
Experimental: Thermal ablation
Patients included will undergo ultrasound guided thermal ablation of hepatic metastases, allowing resection for additional unablatable lesions.
Procedure: Thermal ablation
Patients will undergo either radiofrequency ablation (RFA) or microwave ablation (MWA).
- Overall survival (OS) [ Time Frame: 5 years ]Counting from the date of randomization to the date of death of the patient or to the last day of follow-up.
- Disease free survival [ Time Frame: 5 years ]The time from focal therapy to the time of events.
- Time to progression [ Time Frame: 5 years ]The time from focal therapy to the time of events.
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): NCT03088150
|Contact: RS Puijk, MD||020 444 firstname.lastname@example.org|
|Contact: MR Meijerink, MD, PhD||020 444 email@example.com|
|Amsterdam University Medical Center - location VUmc||Recruiting|
|Amsterdam, NH, Netherlands, 1081|
|Contact: M.R. Meijerink, MD, PhD 0204444444 firstname.lastname@example.org|
|Principal Investigator:||MR Meijerink, MD, PhD||VU University Medical Center, Amsterdam, NL|