ColoRectal CancerCOLLISIONNCT03088150
COLLISION Trial - Colorectal Liver Metastases: Surgery vs Thermal Ablation
A study testing Thermal ablation and Surgical resection in people with ColoRectal Cancer and Liver Metastasis Colon Cancer, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ColoRectal Cancer, Liver Metastasis Colon Cancer, Liver Metastases
- What is being tested?
- Thermal ablation and Surgical resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 618 participants
- Where
- 1 siteNetherlands
- Study dates
- 13 Jul 2017to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam University Medical Center - location VUmc
Amsterdam, North Holland, 1081
M.R. Meijerink, MD, PhD, 0204444444, interventieradiologie@vumc.nl
About this study
Official title: COLLISION Trial - Colorectal Liver Metastases: Surgery vs Thermal Ablation, a Phase III Single-blind Prospective Randomized Controlled Trial
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.
Read the detailed description
Study design:
COLLISION is a single-blind prospective multi-center phase-III randomized controlled trial. We hypothesize that thermal ablation is non-inferior to surgery for the selected patient groups in terms of the primary objective (overall survival). The Cox proportional hazards model (1-sided; non-inferiority or superiority) is used for sample size calculations. Given the superior safety profile we consider a hazard ratio of 1.3 to represent the upper limit of non-inferiority (non-inferiority margin). An HR of 1.3 corresponds to a 56.5% chance of the ablated patients to die first ((P = HR/(1 + HR) = 1.3/(1 + 1.3) = 0.565 (56.5%)). With 3 years of patient accrual and five years of follow-up we will have reached 60% of events (death) in approximately 6.5 years (overall probability of event, pE =0.6). The calculated sample size therefore is 599 (NS).To account for a 10% drop-out ratio (NDO=69) prior to randomization and a 3% loss to follow-up (NLTFU=18) after randomization we need to include 687 patients (NI). A total number of 618 patients will be randomized (NR) into one of two arms: arm A will undergo surgical resection (n=309) and arm B thermal ablation (n=309) for appointed target lesions.
Study population:
Patients with ≥1 resectable and ablatable CRLM (≤3cm), no extrahepatic disease and a good performance status (WHO 0-2) are considered eligible. Supplementary resections for resectable lesions >3cm and thermal ablations for unresectable CRLM ≤3cm are allowed with a maximum number of CRLM of 10.
Intervention:
Eligible patients will be stratified into low-, intermediate- and high disease burden after assessment by an expert panel. The panel, consisting of at least two diagnostic radiologists, two interventional radiologists and two hepatobiliary and/or oncological surgeons, will appoint lesions that are resectable and ablatable as target lesions, resectable and unablatable lesions as unablatable lesions and ablatable but unresectable lesions as unresectable lesions. All unablatable lesions should be resectable and all unresectable lesions should be ≤3cm and ablatable.
With the exception of patients that are suitable for laparoscopic resection or percutaneous ablation (low disease burden), eligibility needs to be reconfirmed during the surgical procedure. Hereafter patients will be randomized to undergo surgical resection of the target lesions (allowing thermal ablation for additional unresectable lesions) or thermal ablation (allowing resection for additional unablatable lesions). For open procedures randomization will be performed shortly after surgical inspection and IOUS with the patient under general anaesthesia. Both the experimenter(s) and the participant will be unaware of the eventual treatment arm prior to the procedure; after the procedure the patient will remain unaware (single-blind).
Conferring to national guidelines follow-up will include imaging, laboratory tests including tumour markers (CEA) and clinical examination every 3 months for the first year and every 6 months hereafter. Follow-up cross-sectional imaging should include at least an abdominal ceCT or upper abdominal ceMRI at the given time-points. Participating centres are free to add 18F-FDG PET-CTs at specific time-points or to use alternating specific modalities, as long as the follow-up protocol is pre-approved by the trial coordinators and as long as follow-up imaging is identical for both treatment arms. Quality of life questionnaires will be assessed at baseline, every 3 months for the first year and every 6 months hereafter accordingly.
Patients with recurrences that are considered unsuitable for additional focal therapy will be re-referred to their medical oncologist to assess additional systemic chemotherapy. In the event of chemotherapeutic down-staging hereafter, focal therapy can be reconsidered.
- Being tested
- Thermal ablation, Surgical resection
- Keywords
- Hepatic resection, Liver surgery, Thermal ablation, Radiofrequency ablation, Microwave ablation, RFA, MWA
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermal ablationProcedure or surgery
Also called Radiofrequency ablation, RFA, Microwave ablation, MWA
Patients will undergo either radiofrequency ablation (RFA) or microwave ablation (MWA).
Surgical resectionProcedure or surgery
In case of randomization to surgical resection, the surgeon will remove all target lesions as well as all additional unablatable lesions.
| Study group | Role | What they receive |
|---|---|---|
| Surgical resection | Active comparator | Patients included will undergo resection of hepatic metastases, allowing thermal ablation for additional unresectable lesions. Receives: Procedure: Surgical resection |
| Thermal ablation | Experimental | Patients included will undergo ultrasound guided thermal ablation of hepatic metastases, allowing resection for additional unablatable lesions. Receives: Procedure: Thermal ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (2)
Disease free survival
The time from focal therapy to the time of events.
Measured: 5 years
Time to progression
The time from focal therapy to the time of events.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2017
- Study start13 Jul 2017
- Primary completionJul 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ColoRectal CancerStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 618 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic - MITG
- Responsible party
- Principal investigator, Dr. M.R. Meijerink, Amsterdam UMC, location VUmc
- Investigators
- MR Meijerink, MD, PhD, Principal investigator, VU University Medical Center, Amsterdam, NL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03088150
- Sponsor's protocol ID
- NL58551.029.16
- Acronym
- COLLISION
- Status last verified
- Dec 2022
- First submitted
- 11 Jan 2017
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39848272Puijk 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.
PubMed 30111304
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COLLISION Trial - Colorectal Liver Metastases: Surgery vs Thermal Ablation, a Phase III Single-blind Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03088150
- Acronym / sponsor ID
- COLLISION / NL58551.029.16
- Keywords
- Hepatic resection, Liver surgery, Thermal ablation, Radiofrequency ablation, Microwave ablation, RFA, MWA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 618 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Medtronic - MITG
- Study start
- 13 Jul 2017 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 23 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study design:
COLLISION is a single-blind prospective multi-center phase-III randomized controlled trial. We hypothesize that thermal ablation is non-inferior to surgery for the selected patient groups in terms of the primary objective (overall survival). The Cox proportional hazards model (1-sided; non-inferiority or superiority) is used for sample size calculations. Given the superior safety profile we consider a hazard ratio of 1.3 to represent the upper limit of non-inferiority (non-inferiority margin). An HR of 1.3 corresponds to a 56.5% chance of the ablated patients to die first ((P = HR/(1 + HR) = 1.3/(1 + 1.3) = 0.565 (56.5%)). With 3 years of patient accrual and five years of follow-up we will have reached 60% of events (death) in approximately 6.5 years (overall probability of event, pE =0.6). The calculated sample size therefore is 599 (NS).To account for a 10% drop-out ratio (NDO=69) prior to randomization and a 3% loss to follow-up (NLTFU=18) after randomization we need to include 687 patients (NI). A total number of 618 patients will be randomized (NR) into one of two arms: arm A will undergo surgical resection (n=309) and arm B thermal ablation (n=309) for appointed target lesions.
Study population:
Patients with ≥1 resectable and ablatable CRLM (≤3cm), no extrahepatic disease and a good performance status (WHO 0-2) are considered eligible. Supplementary resections for resectable lesions >3cm and thermal ablations for unresectable CRLM ≤3cm are allowed with a maximum number of CRLM of 10.
Intervention:
Eligible patients will be stratified into low-, intermediate- and high disease burden after assessment by an expert panel. The panel, consisting of at least two diagnostic radiologists, two interventional radiologists and two hepatobiliary and/or oncological surgeons, will appoint lesions that are resectable and ablatable as target lesions, resectable and unablatable lesions as unablatable lesions and ablatable but unresectable lesions as unresectable lesions. All unablatable lesions should be resectable and all unresectable lesions should be ≤3cm and ablatable.
With the exception of patients that are suitable for laparoscopic resection or percutaneous ablation (low disease burden), eligibility needs to be reconfirmed during the surgical procedure. Hereafter patients will be randomized to undergo surgical resection of the target lesions (allowing thermal ablation for additional unresectable lesions) or thermal ablation (allowing resection for additional unablatable lesions). For open procedures randomization will be performed shortly after surgical inspection and IOUS with the patient under general anaesthesia. Both the experimenter(s) and the participant will be unaware of the eventual treatment arm prior to the procedure; after the procedure the patient will remain unaware (single-blind).
Conferring to national guidelines follow-up will include imaging, laboratory tests including tumour markers (CEA) and clinical examination every 3 months for the first year and every 6 months hereafter. Follow-up cross-sectional imaging should include at least an abdominal ceCT or upper abdominal ceMRI at the given time-points. Participating centres are free to add 18F-FDG PET-CTs at specific time-points or to use alternating specific modalities, as long as the follow-up protocol is pre-approved by the trial coordinators and as long as follow-up imaging is identical for both treatment arms. Quality of life questionnaires will be assessed at baseline, every 3 months for the first year and every 6 months hereafter accordingly.
Patients with recurrences that are considered unsuitable for additional focal therapy will be re-referred to their medical oncologist to assess additional systemic chemotherapy. In the event of chemotherapeutic down-staging hereafter, focal therapy can be reconsidered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical resection | Active comparator | Procedure: Surgical resectionPatients included will undergo resection of hepatic metastases, allowing thermal ablation for additional unresectable lesions. |
| Thermal ablation | Experimental | Procedure: Thermal ablationPatients included will undergo ultrasound guided thermal ablation of hepatic metastases, allowing resection for additional unablatable lesions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermal ablationAlso: Radiofrequency ablation, RFA, Microwave ablation, MWAPatients will undergo either radiofrequency ablation (RFA) or microwave ablation (MWA). | Procedure or surgery | Thermal ablation |
| Surgical resectionIn case of randomization to surgical resection, the surgeon will remove all target lesions as well as all additional unablatable lesions. | Procedure or surgery | Surgical resection |
Primary outcome
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.
2 secondary outcomes
Disease free survival
Time frame: 5 years
Time to progression
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Derived from this study: PubMed 39848272van 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.
- Derived from this study: PubMed 30111304Puijk 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MR Meijerink, MD, PhD principal investigator
VU University Medical Center, Amsterdam, NL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermal ablation and Surgical resection in people with ColoRectal Cancer and Liver Metastasis Colon Cancer, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact RS Puijk, MD (020 444 4444, interventieradiologie@vumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03088150, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.