Colorectal Cancer MetastaticCOLLISION-XLNCT04081168
COLLISION XL: Unresectable Colorectal Liver Metastases (3-5cm): Stereotactic Body Radiotherapy vs. Microwave Ablation
A study testing Stereotactic Body Radiotherapy and Microwave Ablation in people with Colorectal Cancer Metastatic and Liver Metastasis Colon Cancer, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
Multiple articles report that thermal ablation is a safe and effective treatment for unresectable colorectal liver metastases (CRLM) ≤3cm. However efficacy of thermal ablation decreases with increasing lesion size. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer Metastatic, Liver Metastasis Colon Cancer
- What is being tested?
- Stereotactic Body Radiotherapy and Microwave Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Dec 2020to 15 Jan 2025
- 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
Who may be able to join
- 1-3 unresectable CRLM size 3-5 cm eligible for both MWA and SBRT (target lesions);
- Additional CRLM are allowed if considered either resectable or ablatable and <3cm
- No or limited extrahepatic disease (1 extrahepatic lesion is allowed, not including positive para-aortal lymph nodes, celiac lymph nodes, adrenal metastases, pleural carcinomatosis or peritoneal carcinomatosis);
- For subjects with liver only disease the maximum number of CRLM is 10; for subjects with limited extrahepatic disease the maximum number of CRLM is 5;
- Prior focal liver treatment is allowed
- Subjects without prior focal liver treatment should be either unsuitable for 1st line chemotherapy or have progressed under/after 1st-line chemotherapy;
- Subjects with recurrent (either local or distant-hepatic) CRLM after previous focal treatment should be unsuitable for (further) systemic therapy (further downsizing or conversion to resectable disease improbable).
Who cannot join
- Compromised liver function (e.g. signs of portal hypertension, INR > 1,5 without use of anticoagulants, ascites);
- Pregnant or breast-feeding subjects;
- Immunotherapy ≤ 6 weeks prior to the procedure;
- Chemotherapy ≤ 6 weeks prior to the procedure;
- Severe allergy to contrast media not controlled with premedication.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC
Amsterdam, North Holland, 1081 HV
Martijn Meijerink, MD, PhD, +31204443047, mr.meijerink@amsterdamumc.nl
About this study
Official title: COLLISION XL: Unresectable Colorectal Liver Metastases: Stereotactic Body Radiotherapy vs. Microwave Ablation - a Phase II Prospective Randomized Controlled Trial for Intermediate-size (3 - 5 cm) Colorectal Liver Metastases
Multiple articles report that thermal ablation is a safe and effective treatment for unresectable colorectal liver metastases (CRLM) ≤3cm. However efficacy of thermal ablation decreases with increasing lesion size. Guidelines state that thermal ablation is the preferred option for unresectable CRLM ≤3cm and stereotactic body radiotherapy (SBRT) when thermal ablation is not possible. It remains uncertain what local treatment method should be recommended for unresectable CRLM of 3-5cm.
Read the detailed description
Objective: The primary objective of this study is to compare efficacy of MWA to the efficacy of SBRT with regards to the primary endpoint (local tumour progression free survival at 1 year [1-year LTPFS]) in patients with unresectable CRLM (3 - 5 cm) that are unsuitable for surgery due to either comorbidities, a history of extensive abdominal surgery, a poor performance status or due to a certain unfavourable anatomical location of the tumour.
Study design: COLLISION XL is a prospective multi-centre phase-II randomized controlled trial.
Study population: 68 patients with 1-3 unresectable lesions of 3 - 5cm, unsuitable for (further) chemotherapy regimens, suitable for both MWA and SBRT and no or limited extrahepatic disease (1 extrahepatic lesion is allowed, not including positive para-aortal lymph nodes, celiac lymph nodes, adrenal metastases, pleural carcinomatosis or peritoneal carcinomatosis) are considered eligible. Supplementary resections for resectable lesions and thermal ablations for unresectable CRLM ≤3cm are allowed. A maximum number of 10 CRLM are allowed for patients with no extrahepatic disease and a maximum number of 5 lesions are allowed for patients with limited extrahepatic disease.
Intervention: SBRT or MWA. The panel, consisting of at least two interventional radiologists, two hepatobiliary surgeons and two radiation oncologists, will appoint lesions of 3-5cm that are unresectable and suitable for both MWA and SBRT, as target lesions. All lesions that are not suitable for ablation should be resectable and all unresectable lesions <3cm should be suitable for thermal ablation.
Main study parameters/endpoints: Primary endpoint is local tumour progression free survival (LTPFS) at 1 year from randomization. Secondary endpoints are local tumour progression free survival time, OS, disease-free survival (DFS), time to progression (TTP), procedural morbidity/toxicity and mortality, assessment of pain and quality of life (QoL) and cost-effectiveness ratio (ICER).
- Being tested
- Stereotactic Body Radiotherapy, Microwave Ablation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body RadiotherapyDevice
Also called SBRT
Patients will undergo Stereotactic Body Radiotherapy (SBRT)
Microwave AblationDevice
Also called MWA
Patients will undergo Microwave Ablation (MWA)
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic Body Radiotherapy | Active comparator | Patients included will undergo Stereotactic Body Radiotherapy (SBRT) of hepatic metastases. Receives: Device: Stereotactic Body Radiotherapy |
| Microwave Ablation | Active comparator | Patients included will undergo Microwave Ablation (MWA) of hepatic metastases. Receives: Device: Microwave Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
One-year local tumor progression-free survival
One-year local tumor progression-free survival
Measured: 1 year
Secondary outcomes (4)
Timo-to-local tumor progression
Timo-to-local tumor progression
Measured: 5 years
Overall survival (OS)
Overall survival (OS)
Measured: 5 years
Disease-Free Survival (DFS)
Disease-Free Survival (DFS)
Measured: 5 years
Mortality
Mortality
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 posted9 Sep 2019
- Study start15 Dec 2020
- Primary completion15 Sep 2024 (estimated)
- Study completion15 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer MetastaticStudies 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
- Model description
- Stereotactic Body Radiotherapy vs. Microwave Ablation
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. M.R. Meijerink, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04081168
- Sponsor's protocol ID
- NL68326.029.19
- Acronym
- COLLISION-XL
- Status last verified
- Dec 2022
- First submitted
- 27 Aug 2019
- 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, Dijkstra M, Nieuwenhuizen S, Schulz HH, Vos DJW, Versteeg KS, Buffart TE, Swijnenburg RJ, de Vries JJJ, Bruynzeel AME, van den Tol MP, Scheffer HJ, Puijk RS, Haasbeek CJA, Meijerink MR; and COLLISION Trial Group. Unresectable Intermediate-Size (3-5 cm) Colorectal Liver Metastases: Stereotactic Ablative Body Radiotherapy Versus Microwave Ablation (COLLISION-XL): Protocol of a Phase II/III Multicentre Randomized Controlled Trial. Cardiovasc Intervent Radiol. 2023 Aug;46(8):1076-1085. doi: 10.1007/s00270-023-03498-8. Epub 2023 Jul 10.
PubMed 37430016
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 XL: Unresectable Colorectal Liver Metastases: Stereotactic Body Radiotherapy vs. Microwave Ablation - a Phase II Prospective Randomized Controlled Trial for Intermediate-size (3 - 5 cm) Colorectal Liver Metastases
- ClinicalTrials.gov ID
- NCT04081168
- Acronym / sponsor ID
- COLLISION-XL / NL68326.029.19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 15 Sep 2024 (estimated)
- Study completion
- 15 Jan 2025 (estimated)
- First posted
- 9 Sep 2019 (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.
Multiple articles report that thermal ablation is a safe and effective treatment for unresectable colorectal liver metastases (CRLM) ≤3cm. However efficacy of thermal ablation decreases with increasing lesion size. Guidelines state that thermal ablation is the preferred option for unresectable CRLM ≤3cm and stereotactic body radiotherapy (SBRT) when thermal ablation is not possible. It remains uncertain what local treatment method should be recommended for unresectable CRLM of 3-5cm.
Detailed description
Objective: The primary objective of this study is to compare efficacy of MWA to the efficacy of SBRT with regards to the primary endpoint (local tumour progression free survival at 1 year [1-year LTPFS]) in patients with unresectable CRLM (3 - 5 cm) that are unsuitable for surgery due to either comorbidities, a history of extensive abdominal surgery, a poor performance status or due to a certain unfavourable anatomical location of the tumour.
Study design: COLLISION XL is a prospective multi-centre phase-II randomized controlled trial.
Study population: 68 patients with 1-3 unresectable lesions of 3 - 5cm, unsuitable for (further) chemotherapy regimens, suitable for both MWA and SBRT and no or limited extrahepatic disease (1 extrahepatic lesion is allowed, not including positive para-aortal lymph nodes, celiac lymph nodes, adrenal metastases, pleural carcinomatosis or peritoneal carcinomatosis) are considered eligible. Supplementary resections for resectable lesions and thermal ablations for unresectable CRLM ≤3cm are allowed. A maximum number of 10 CRLM are allowed for patients with no extrahepatic disease and a maximum number of 5 lesions are allowed for patients with limited extrahepatic disease.
Intervention: SBRT or MWA. The panel, consisting of at least two interventional radiologists, two hepatobiliary surgeons and two radiation oncologists, will appoint lesions of 3-5cm that are unresectable and suitable for both MWA and SBRT, as target lesions. All lesions that are not suitable for ablation should be resectable and all unresectable lesions <3cm should be suitable for thermal ablation.
Main study parameters/endpoints: Primary endpoint is local tumour progression free survival (LTPFS) at 1 year from randomization. Secondary endpoints are local tumour progression free survival time, OS, disease-free survival (DFS), time to progression (TTP), procedural morbidity/toxicity and mortality, assessment of pain and quality of life (QoL) and cost-effectiveness ratio (ICER).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stereotactic Body Radiotherapy vs. Microwave Ablation
| Arm | Type | Receives |
|---|---|---|
| Stereotactic Body Radiotherapy | Active comparator | Device: Stereotactic Body RadiotherapyPatients included will undergo Stereotactic Body Radiotherapy (SBRT) of hepatic metastases. |
| Microwave Ablation | Active comparator | Device: Microwave AblationPatients included will undergo Microwave Ablation (MWA) of hepatic metastases. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1-3 unresectable CRLM size 3-5 cm eligible for both MWA and SBRT (target lesions);
- Additional CRLM are allowed if considered either resectable or ablatable and <3cm
- No or limited extrahepatic disease (1 extrahepatic lesion is allowed, not including positive para-aortal lymph nodes, celiac lymph nodes, adrenal metastases, pleural carcinomatosis or peritoneal carcinomatosis);
- For subjects with liver only disease the maximum number of CRLM is 10; for subjects with limited extrahepatic disease the maximum number of CRLM is 5;
- Prior focal liver treatment is allowed
Key exclusion criteria (5 listed)
- Compromised liver function (e.g. signs of portal hypertension, INR > 1,5 without use of anticoagulants, ascites);
- Pregnant or breast-feeding subjects;
- Immunotherapy ≤ 6 weeks prior to the procedure;
- Chemotherapy ≤ 6 weeks prior to the procedure;
- Severe allergy to contrast media not controlled with premedication.
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 |
|---|---|---|
| Stereotactic Body RadiotherapyAlso: SBRTPatients will undergo Stereotactic Body Radiotherapy (SBRT) | Device | Stereotactic Body Radiotherapy |
| Microwave AblationAlso: MWAPatients will undergo Microwave Ablation (MWA) | Device | Microwave Ablation |
Primary outcome
One-year local tumor progression-free survival
Time frame: 1 year
One-year local tumor progression-free survival
4 secondary outcomes
Timo-to-local tumor progression
Time frame: 5 years
Overall survival (OS)
Time frame: 5 years
Disease-Free Survival (DFS)
Time frame: 5 years
Mortality
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 37430016van der Lei S, Dijkstra M, Nieuwenhuizen S, Schulz HH, Vos DJW, Versteeg KS, Buffart TE, Swijnenburg RJ, de Vries JJJ, Bruynzeel AME, van den Tol MP, Scheffer HJ, Puijk RS, Haasbeek CJA, Meijerink MR; and COLLISION Trial Group. Unresectable Intermediate-Size (3-5 cm) Colorectal Liver Metastases: Stereotactic Ablative Body Radiotherapy Versus Microwave Ablation (COLLISION-XL): Protocol of a Phase II/III Multicentre Randomized Controlled Trial. Cardiovasc Intervent Radiol. 2023 Aug;46(8):1076-1085. doi: 10.1007/s00270-023-03498-8. Epub 2023 Jul 10.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic Body Radiotherapy and Microwave Ablation in people with Colorectal Cancer Metastatic 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?
The sponsor lists 7 inclusion and 5 exclusion criteria. 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 S. van der Lei, MD (+31204443047, s.vanderlei@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One-year local tumor progression-free survival (time frame: 1 year). 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 NCT04081168, which also lists 1 linked publication.
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.