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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
Sponsor:
Collaborator:
Medtronic - MITG
Information provided by (Responsible Party):
Dr. M.R. Meijerink, VU University Medical Center

Brief Summary:
The primary objective is to prove non-inferiority of thermal ablation compared to hepatic resection in patients with at least one resectable and ablatable colorectal liver metastases (≤3cm) and no extrahepatic disease.

Condition or disease Intervention/treatment Phase
ColoRectal Cancer Liver Metastasis Colon Cancer Liver Metastases Surgery Procedure: Thermal ablation Procedure: Surgical resection Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 618 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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).
Other Names:
  • Radiofrequency ablation
  • RFA
  • Microwave ablation
  • MWA




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Disease free survival [ Time Frame: 5 years ]
    The time from focal therapy to the time of events.

  2. Time to progression [ Time Frame: 5 years ]
    The time from focal therapy to the time of events.



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.


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

Most important inclusion criteria:

  • At least one CRLM size ≤ 3 cm eligible for both surgical resection and thermal ablation (target lesions);
  • Additional unresectable CRLM should be ≤ 3 cm and ablatable (unresectable lesions);
  • Additional unablatable CRLM should be resectable (unablatable lesions);
  • Maximum number of CRLM 10;
  • Resectability and ablatability should be re-confirmed intra-operatively by US plus full exploration for hepatic, peritoneal and regional lymph node metastases;
  • ASA 1-3.

Most important exclusion criteria:

  • No target lesions suitable for both resection and ablation;
  • Radical treatment unfeasible or unsafe (e.g. insufficient FLR);
  • The presence of extrahepatic nodal or non-nodal metastases;
  • Immunotherapy or chemotherapy ≤ 6 weeks prior to the procedure;
  • Any surgical resection or focal ablative liver therapy for CRLM prior to 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): NCT03088150


Contacts
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Contact: RS Puijk, MD 020 444 4444 interventieradiologie@vumc.nl
Contact: MR Meijerink, MD, PhD 020 444 4444 interventieradiologie@vumc.nl

Locations
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Netherlands
Amsterdam University Medical Center - location VUmc Recruiting
Amsterdam, NH, Netherlands, 1081
Contact: M.R. Meijerink, MD, PhD    0204444444    interventieradiologie@vumc.nl   
Sponsors and Collaborators
VU University Medical Center
Medtronic - MITG
Investigators
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Principal Investigator: MR Meijerink, MD, PhD VU University Medical Center, Amsterdam, NL

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. M.R. Meijerink, Dr, VU University Medical Center
ClinicalTrials.gov Identifier: NCT03088150    
Other Study ID Numbers: NL58551.029.16
First Posted: March 23, 2017    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. M.R. Meijerink, VU University Medical Center:
Hepatic resection
Liver surgery
Thermal ablation
Radiofrequency ablation
Microwave ablation
RFA
MWA
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases