COLLISION XL: 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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- One-year local tumor progression-free survival
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
结局指标
主要结局
One-year local tumor progression-free survival
时间窗: 1 year
One-year local tumor progression-free survival
次要结局
- Overall survival (OS)(5 years)
- Disease-Free Survival (DFS)(5 years)
- Timo-to-local tumor progression(5 years)
- Mortality(5 years)
研究者
Dr. M.R. Meijerink
Principal Investigator
Amsterdam UMC, location VUmc