COLLISION XL
Huidige inclusies:
0/360 (0%)
Doel:
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
Samenvatting:
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.
Primaire uitkomst:
- Local tumour progression free survival (LTPFS) at 1 year from randomization.
Secundaire uitkomsten:
- Local tumour progression free survival time
- Overall Survival (OS)
- Disease-free survival (DFS)
- Time to progression (TTP)
- Procedural
- Morbidity/toxicity and mortality
- Assessment of pain and quality of life (QoL)
- Costeffectiveness ratio (ICER)
Ontwerp:
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
Duur:
- 1 jaar follow-up
Inclusiecriteria:
Screening must be performed no longer than 6 weeks prior to study inclusion. Subjects are eligible if they meet the following criteria: Histological documentation of primary colorectal tumour; 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); Resection for resectable lesions considered possible obtaining negative resection margins (R0) and preserving adequate future liver remnant (FLR); Age >18 years; Written informed consent
Exclusiecriteria:
Subjects who meet the following criteria at the time of screening will be excluded: No target lesions suitable for both MWA and SBRT; Radical treatment unfeasible or unsafe (e.g. insufficient FLR); 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;
Registraties:
| International Clinical Trial Registry Platform (ICTRP) nummer: | CTIS2024-515341-41-01 |
|---|---|
| EU Clinical Trials Register (EUCT): | 2024-515341-41-01 |
| Centrale Commissie Mensgebonden Onderzoek (CCMO): | NL78220.029.22 |
