COLLISION-XL trial: Unresectable colorectal liver metastases: stereotactic body radiotherapy versus microwave ablation - a phase II prospective randomized controlled trial for CRLM 3-5 cm

COLLISION-XL trial: Unresectable colorectal liver metastases: stereotactic body radiotherapy versus microwave ablation - a phase II prospective randomized controlled trial for CRLM 3-5 cm - COLLISION XL - SBRT vs MWA for unresectable CRLM 3-5 cm

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON52908

Enrollment

Registered

2019-08-06

Start date

2020-10-28

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colorectal liver metastases

Interventions

SBRT or MWA. The expert panel, consisting of at least two interventional radiologists, two hepatobiliary surgeons and two radiation oncologists, will appoint lesions of 3-5cm, that are unresectable

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Histological documentation of primary colorectal tumour; • 1-3 unresectable CRLM size 3-5 cm eligible for both MWA and SBRT (target lesions); • Additional unresectable CRLM 18 years; • Written informed consent

Exclusion criteria

Exclusion criteria: • Pregnant or breast-feeding subjects; • Immunotherapy

Design outcomes

Primary

Measure	Time frame
Primary endpoint is local tumour progression free survival (LTPFS) at 1 year.	—

Secondary

Measure	Time frame
Secondary endpoints are overall survival (OS), Local tumour progression free survival time, disease-free survival (DFS), time to progression (TTP), distant progression free survival (DPFS), procedural morbidity/toxicity and mortality, assessment of pain and quality of life (QoL) and cost-effectiveness ratio (ICER).	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)