NCT03408665进行中（未招募）不适用
Phase II Study, Stratified, Non-randomized, Estimating SBRT Efficiency and Toxicity in Primary and Secondary Liver Tumors
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 280
- 试验地点
- 7
- 主要终点
- SBRT efficiency in term of L-PFS for patient who are to be treated with SBRT in patients with primitive hepatic tumor of hepatic metastatis
研究概览
简要总结
Intervention research involving the human person, phase II, prospective, multicentric, non-randomized and multi-cohort study. The eligibility criteria are broad, on purpose, so every patient, able to be treated by SBRT and unable to participate in another trial (non eligible patient or non included centers), can be included in this national study, in a prospective way.
详细描述
Patients will first go through an inclusion check-up consisting of:
- a clinical exam: disease history, previous treatments, weight, height, patient's performance status (ECOG) and HCC status.
- a biological test: biochemical (total bilirubin, ASAT-ALAT, LDH, albumin, alkaline phosphatases, GGT), hematological (if the patient is going to receive a fiducial), alphafoetoprotein (for HCC) and pregnancy test (if applicable)
- a tumor assessment: using a CT-scan or a MRI and using RECIST or mRECIST (if HCC), plus other morphological exams if judged useful by the investigator This check-up has to be realized within 28 days before inclusion. Then, the use of fiducial is optional.
Before the beginning of the treatment, a pre-therapeutic check-up is done:
- the inclusion check-up has to be done a second time if the treatment begins more than 28 days after the first one
- Tracking scanner.
The SBRT treatment is done in 3 to 6 times and no specific SBRT techniques are asked for, the investigator can choose according to the center habits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 old
- •With primary or secondary liver tumor and matching one of the following situations:
- •Liver Metastasis (LM): anatomopathologic diagnosis of the primary tumor
- •Hepatocellular Carcinoma (HCC): diagnosis achieved through biopsy or through non-invasive methods approved by AASLD criteria (Bruix, 2011)
- •Cholangiocarcinoma (CC): diagnosis achieved through biopsy
- •Other primitive hepatic tumor achieved through biopsy
- •Meet the requirements for SBRT treatment:
- •Liver Metastasis (LM): oligometastatic disease
- •Hepatocellular Carcinoma (HCC): non eligible lesion to curative surgery
- •Cholangiocarcinoma (CC): nodular lesion
- •Other primitive hepatic tumor: non eligible lesion to curative surgery
- •Able to receive a SBRT treatment according to the multidisciplinary consultation meeting
- •Tumor assessable with CT-scan or MRI according to mRECIST in HCC or Recist 1.1 in other situations
- •Affiliation to the National Social Security System
- •With informed and signed consent
排除标准
- •Eligibility to a curative surgery according to the multidisciplinary consultation meeting
- •Contraindication to SBRT (especially Cirrhose Child C)
- •Pregnant or breastfeeding women
- •Patient Under guardianship or tutorship
- •Impossibility to submit at the study procedures due to geographic, social or mental reasons
研究组 & 干预措施
SBRT
Experimental
Stereotaxic Body Radiation Therapy administred in 3 to 6 fractions.
干预措施: SBRT (Radiation)
结局指标
主要结局
SBRT efficiency in term of L-PFS for patient who are to be treated with SBRT in patients with primitive hepatic tumor of hepatic metastatis
时间窗: From baseline to 36 months following up.
Local progression-free survival (L-PFS) thanks to Kaplan-Meier method from registration date to date of local progressive disease.
次要结局
- Estimate the SBRT efficiency in a prospective way, in term of local progression-free survival (L-PFS) for patient treated with SBRT in the 4 considered clinical situations.(From baseline to 36 months following up.)
- Describe the different SBRT techniques used in the study for liver tumor.(From baseline to 36 months following up.)
- Determine the SBRT feasibility by comparison of planned SBRT to performed SBRT.(From baseline to 36 months following up.)
- Estimate the SBRT efficiency in a prospective way, in term of overall survival (OS) in the 4 considered clinical situations.(From baseline to 36 months following up.)
- Estimate the SBRT efficiency in a prospective way, in term of progression-free survival (PFS) in the 4 considered clinical situations.(From baseline to 36 months following up.)
- Assess the immediate and delayed toxicity.(From baseline to 36 months following up.)
- Estimate the quality-adjusted survival (Q-TWiST) for patients in each of the 4 considered clinical situations.(From baseline to 36 months following up.)
- Estimate the proportion of patients for whom an hospitalization is required.(From baseline to 36 months following up.)
- Estimate the impact of the different SBRT techniques on SBRT efficacy according to L-PFS.(From baseline to 36 months following up.)
- Estimate the impact of the different SBRT techniques on SBRT efficacy according to PFS.(From baseline to 36 months following up.)
- Estimate the impact of the different SBRT techniques on SBRT efficacy according to OS.(From baseline to 36 months following up.)
- Quality of life according to QLQ-C30 questionnaire(From Baseline to the 6-months follow-up)
研究者
研究点 (7)
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