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
; 46(8): 1076-1085, 2023 Aug.
Article
em En
| MEDLINE
| ID: mdl-37430016
ABSTRACT
BACKGROUND:
Although microwave ablation (MWA) has a low complication rate and good efficacy for small-size (≤ 3 cm) colorectal liver metastases (CRLM), local control decreases with increasing size. Stereotactic body radiotherapy (SBRT) is gaining interest as a potential means to treat intermediate-size CRLM and might be less susceptible to increasing volume. The objective of this study is to compare the efficacy of MWA to SBRT in patients with unresectable, intermediate-size (3-5 cm) CRLM.METHODS:
In this two-arm, multicentre phase II/ III randomized controlled trial, 68 patients with 1-3 unresectable, intermediate-size CRLM suitable for both MWA and SBRT, will be included. Patients will be treated with MWA or SBRT as randomised. The Primary endpoint is local tumour progression-free survival (LTPFS) at 1 year (intention-to-treat analysis). Main secondary endpoints are overall survival, overall and distant progression-free survival (DPFS), local control (LC) and procedural morbidity and mortality and assessment of pain and quality of life.DISCUSSION:
Current guidelines lack clear recommendations for the local treatment of liver only intermediate-size, unresectable CRLM and studies comparing curative intent SBRT and thermal ablation are scarce. Although safety and feasibility to eradicate tumours ≤ 5 cm have been established, both techniques suffer from lower LTPFS and LC rates for larger-size tumours. For the treatment of unresectable intermediate-size CRLM clinical equipoise has been reached. We have designed a two-armed phase II/ III randomized controlled trial directly comparing SBRT to MWA for unresectable CRLM 3-5 cm. LEVEL OF EVIDENCE Level 1, phase II/ III Randomized controlled trial. TRIAL REGISTRATION NCT04081168, September 9th 2019.Palavras-chave
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Eixos temáticos:
Pesquisa_clinica
Base de dados:
MEDLINE
Assunto principal:
Neoplasias Colorretais
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Radiocirurgia
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Neoplasias Hepáticas
Tipo de estudo:
Clinical_trials
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Guideline
/
Qualitative_research
Limite:
Humans
Idioma:
En
Ano de publicação:
2023
Tipo de documento:
Article