NCT03088150

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
618

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 23, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

July 13, 2017

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

December 20, 2022

Status Verified

December 1, 2022

Enrollment Period

7 years

First QC Date

January 11, 2017

Last Update Submit

December 18, 2022

Conditions

ColoRectal CancerLiver Metastasis Colon CancerLiver MetastasesSurgery

Keywords

Hepatic resectionLiver surgeryThermal ablationRadiofrequency ablationMicrowave ablationRFAMWA

Outcome Measures

Primary Outcomes (1)

  • Overall survival (OS)

    Counting from the date of randomization to the date of death of the patient or to the last day of follow-up.

    5 years

Secondary Outcomes (2)

  • Disease free survival

    5 years

  • Time to progression

    5 years

Study Arms (2)

Surgical resection

ACTIVE COMPARATOR

Patients included will undergo resection of hepatic metastases, allowing thermal ablation for additional unresectable lesions.

Procedure: Surgical resection

Thermal ablation

EXPERIMENTAL

Patients included will undergo ultrasound guided thermal ablation of hepatic metastases, allowing resection for additional unablatable lesions.

Procedure: Thermal ablation

Interventions

Thermal ablationPROCEDURE

Patients will undergo either radiofrequency ablation (RFA) or microwave ablation (MWA).

Also known as: Radiofrequency ablation, RFA, Microwave ablation, MWA
Thermal ablation
Surgical resectionPROCEDURE

In case of randomization to surgical resection, the surgeon will remove all target lesions as well as all additional unablatable lesions.

Surgical resection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam University Medical Center - location VUmc

Amsterdam, North Holland, 1081, Netherlands

RECRUITING

Related Publications (2)

  • van der Lei S, Puijk RS, Dijkstra M, Schulz HH, Vos DJW, De Vries JJJ, Scheffer HJ, Lissenberg-Witte BI, Aldrighetti L, Arntz M, Barentsz MW, Besselink MG, Bracke B, Bruijnen RCG, Buffart TE, Burgmans MC, Chapelle T, Coolsen MME, de Boer SW, de Cobelli F, de Jong K, de Wilt JHW, Diederik AL, Dooper AMC, Draaisma WA, Eker HH, Erdmann JI, Futterer JJ, Geboers B, Groot GMC, Hagendoorn J, Hartgrink HH, Horsthuis K, Hurks R, Jenniskens SFM, Kater M, Kazemier G, Kist JW, Klaase JM, Knapen RRMM, Kruimer JWH, Lamers ABGN, Leclercq WKG, Liefers GJ, Manusama ER, Meier MAJ, Melenhorst MCAM, Mieog JSD, Molenaar QI, Nielsen K, Nijkamp MW, Nieuwenhuijs VB, Nota IMGC, Op de Beeck B, Overduin CG, Patijn GA, Potters FH, Ratti F, Rietema FJ, Ruiter SJS, Schouten EAC, Schreurs WH, Serafino G, Sietses C, Slooter GD, Smits MLJ, Soykan EA, Spaargaren GJ, Stommel MWJ, Timmer FEF, van Baardewijk LJ, van Dam RM, van Delden OM, van den Bemd BAT, van den Bergh JE, van den Boezem PB, van der Leij C, van der Meer RW, van der Meijs BBM, van der Ploeg APT, van der Reijden JJ, van Duijvendijk P, van Erkel AR, van Geel AM, Van Heek NT, van Manen CJ, van Rijswijk CSP, van Waesberghe JHTM, Versteeg KS, Vink T, Zijlstra IAJ, Zonderhuis BM, Swijnenburg RJ, van den Tol MP, Meijerink MR. Thermal ablation versus surgical resection of small-size colorectal liver metastases (COLLISION): an international, randomised, controlled, phase 3 non-inferiority trial. Lancet Oncol. 2025 Feb;26(2):187-199. doi: 10.1016/S1470-2045(24)00660-0. Epub 2025 Jan 20.

    PMID: 39848272DERIVED

  • Puijk RS, Ruarus AH, Vroomen LGPH, van Tilborg AAJM, Scheffer HJ, Nielsen K, de Jong MC, de Vries JJJ, Zonderhuis BM, Eker HH, Kazemier G, Verheul H, van der Meijs BB, van Dam L, Sorgedrager N, Coupe VMH, van den Tol PMP, Meijerink MR; COLLISION Trial Group. Colorectal liver metastases: surgery versus thermal ablation (COLLISION) - a phase III single-blind prospective randomized controlled trial. BMC Cancer. 2018 Aug 15;18(1):821. doi: 10.1186/s12885-018-4716-8.

    PMID: 30111304DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Transurethral Resection of ProstateRadiofrequency Ablation

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

ProstatectomyUrologic Surgical Procedures, MaleUrologic Surgical ProceduresUrogenital Surgical ProceduresSurgical Procedures, OperativeRadiofrequency TherapyTherapeuticsAblation Techniques

Study Officials

  • MR Meijerink, MD, PhD

    VU University Medical Center, Amsterdam, NL

    PRINCIPAL INVESTIGATOR

Central Study Contacts

RS Puijk, MD

CONTACT

020 444 4444interventieradiologie@vumc.nl

MR Meijerink, MD, PhD

CONTACT

020 444 4444interventieradiologie@vumc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

January 11, 2017

First Posted

March 23, 2017

Study Start

July 13, 2017

Primary Completion

July 1, 2024

Study Completion

December 1, 2024

Last Updated

December 20, 2022

Record last verified: 2022-12

Locations

NL(1)