COLLISION XL: Unresectable Colorectal Liver Metastases (3-5cm): Stereotactic Body Radiotherapy vs. Microwave Ablation

Last updated: December 18, 2022
Sponsor: Amsterdam UMC, location VUmc
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neoplasm Metastasis

Liver Cancer

Primary Biliary Cholangitis

Treatment

N/A

Clinical Study ID

NCT04081168
NL68326.029.19
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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 includingpositive para-aortal lymph nodes, celiac lymph nodes, adrenal metastases, pleuralcarcinomatosis or peritoneal carcinomatosis);
  • For subjects with liver only disease the maximum number of CRLM is 10; for subjectswith 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 linechemotherapy or have progressed under/after 1st-line chemotherapy;
  • Subjects with recurrent (either local or distant-hepatic) CRLM after previous focaltreatment should be unsuitable for (further) systemic therapy (further downsizing orconversion to resectable disease improbable).

Exclusion

Exclusion Criteria:

  • Compromised liver function (e.g. signs of portal hypertension, INR > 1,5 without useof 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.

Study Design

Total Participants: 68
Study Start date:
December 15, 2020
Estimated Completion Date:
January 15, 2025

Study 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).

Connect with a study center

  • Amsterdam UMC

    Amsterdam, Noord Holland 1081 HV
    Netherlands

    Active - Recruiting

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