A Randomized Phase III Trial on Stereotactic Body Radiation Therapy (SBRT) Versus Microwave Ablation (MWA) for Inoperable Colorectal Liver Metastases (CLM)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Control of local disease
研究概览
简要总结
The trial is designed to perform a rigorous evaluation of efficacy and tolerability of SBRT by means of a randomised, controlled trial in patients affected by inoperable colorectal liver metastases. The chosen comparator is MWA.
The two modality treatments (SBRT versus MWA) will be evaluated for short- and longer-term outcomes.
详细描述
The trial is a monocentric prospective, randomised controlled, unblinded, parallel-group superiority trial of Stereotactic Body Radiation Therapy (SBRT) versus Microwave Ablation (MWA) for the curative treatment of inoperable colorectal liver metastases. Patients will be randomised on an equal basis to either SBRT or MWA. The two modality treatments (SBRT versus MWA) will be evaluated for short- and longer-term outcomes. The key short-term outcomes will include assessment of local response rate and acute toxicity. Longer-term outcomes will concentrate on oncological aspects of the disease with analysis of disease-free and overall survival and local recurrence rates at 3-year follow-up.
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
- •Age >18 years
- •Karnofsky index >70%
- •Histological proven adenocarcinoma of the colon or rectum with radiological (by CT- or MRI) or histological-/cytological verified liver metastases.
- •Metastases must be visible on diagnostic- and dose planning CT scans and on ultrasonography.
- •The patient should not be suitable for surgical resection due to technical or patient-related conditions. Resectability must be judged by a trained hepatobiliary surgeon and discussed in a multidisciplinary team meeting.
- •Presence of 1-3 lesions .
- •Diameter ≤ 40 mm.
- •All tumors should be feasible for treatment with each of the two modalities, SBRT and MWA
- •Adequate liver function: bilirubin <1.5 mg/dl, alb> 3.5g/dl, normal PT/PTT except if the patient uses anticoagulants, liver enzymes<3 times upper limit of normal. No ascites.
- •Renal function must be adequate for infusion of iv. contrast for CT-scan.
- •Adequate bone marrow function: Hbg³8 g/dl, platelets³100.000 and leucocytes ³2.000/ml.
- •Informed consent.
- •Extrahepatic disease stable or in response after CT
- •No previous abdominal radiation therapy (RT)
排除标准
- •Uncontrolled primary tumor or extrahepatic disease
- •Previous abdominal radiation therapy (RT) or other local conservative treatment on lesion target.
- •Pregnant or breastfeeding patients.
- •Prior malignancy within the last five years (except adequately treated basal cell carcinoma of the skin or in situ carcinoma of the skin or in situ carcinoma of the cervix, surgically cured, or localized prostate cancer without evidence of biochemical progression).
- •Previous inclusion in this study.
- •Underlying liver cirrhosis (Child-Pugh grade B or C).
- •Ascites and/or relevant intra-hepatic biliary tract dilatation.
- •Mental conditions rendering the patient incapable to understand the nature, scope, and consequences of the study.
结局指标
主要结局
Control of local disease
时间窗: 18 months
Evaluation of proportion of patients free from progression from starting radiotherapy
次要结局
- Overall survival of treated patients(18 months)
- Incidence of acute and late complications(18 months)
- Progression free-survival of treated patients(18 months)
研究者
Michele Tedeschi
Medical Doctor
Istituto Clinico Humanitas