NCT04081168

Brief 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. 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.

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
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

Longer than P75 for not_applicable

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

August 27, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 9, 2019

Completed
1.3 years until next milestone

Study Start

First participant enrolled

December 15, 2020

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
Last Updated

December 20, 2022

Status Verified

December 1, 2022

Enrollment Period

3.8 years

First QC Date

August 27, 2019

Last Update Submit

December 18, 2022

Conditions

Colorectal Cancer MetastaticLiver Metastasis Colon Cancer

Outcome Measures

Primary Outcomes (1)

  • One-year local tumor progression-free survival

    One-year local tumor progression-free survival

    1 year

Secondary Outcomes (4)

  • Timo-to-local tumor progression

    5 years

  • Overall survival (OS)

    5 years

  • Disease-Free Survival (DFS)

    5 years

  • Mortality

    5 years

Study Arms (2)

Stereotactic Body Radiotherapy

ACTIVE COMPARATOR

Patients included will undergo Stereotactic Body Radiotherapy (SBRT) of hepatic metastases.

Device: Stereotactic Body Radiotherapy

Microwave Ablation

ACTIVE COMPARATOR

Patients included will undergo Microwave Ablation (MWA) of hepatic metastases.

Device: Microwave Ablation

Interventions

Stereotactic Body RadiotherapyDEVICE

Patients will undergo Stereotactic Body Radiotherapy (SBRT)

Also known as: SBRT
Stereotactic Body Radiotherapy
Microwave AblationDEVICE

Patients will undergo Microwave Ablation (MWA)

Also known as: MWA
Microwave Ablation

Eligibility Criteria

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

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam UMC

Amsterdam, North Holland, 1081 HV, Netherlands

RECRUITING

Related Publications (1)

  • 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.

    PMID: 37430016DERIVED

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

S. van der Lei, MD

CONTACT

+31204443047s.vanderlei@amsterdamumc.nl

M.R. Meijerink, MD, PhD

CONTACT

+31204443047mr.meijerink@amsterdamumc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Stereotactic Body Radiotherapy vs. Microwave Ablation
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 27, 2019

First Posted

September 9, 2019

Study Start

December 15, 2020

Primary Completion

September 15, 2024

Study Completion

January 15, 2025

Last Updated

December 20, 2022

Record last verified: 2022-12

Locations

NL(1)