A Prospective, Post Approval, Multiple Centre, Open-Label, Non-Interventional, Registry Study to Evaluate Effectiveness of TheraSphere® in Clinical Practice in France
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,247
- 试验地点
- 37
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The purpose of this registry study is to gather effectiveness, QoL, safety and procedural information on TheraSphere® for the treatment of participants with Hepatocellular Carcinoma (HCC), Intrahepatic Cholangiocarcinoma (iCC) and liver metastases for colon cancer (mCRC) in real world clinical practice settings in France.
详细描述
TheraSphere is a radioembolic therapeutic device used in the treatment of liver cancers. The goal of the registry study is to collect prospectively: participant description, treatment goal, treatment description, treatment results, safety, quality of life and survival data to ultimately demonstrate that TheraSphere treatment meets the claims that led to the reimbursement in France. The registry study is also an opportunity to improve the proper use of the device by team training especially for the personalized dosimetry treatment approach.
Clinical data will be collected and held in a secured, validated system and can be downloaded by Biocomplatibles UK Ltd Data Management on an ongoing basis. Data verification will be performed by Biocompatibles UK Ltd Data Management and data validation checks will be created by the validated data system (with the Biocompatibles UK Ltd team performing User Acceptance Testing on them before they go live). Adverse Events and concomitant diseases will be coded according to the version of Medical Dictionary for Regulatory Activities (MedDRA) agreed with Biocompatibles UK Ltd. Concomitant medications will be coded using the version of the World Health Organisation (WHO) Drug dictionary agreed with the validated data system.
Appropriate study plans implemented to manage all aspects of the trial to ensure quality and integrity of the data collection.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Overall Survival (OS)
时间窗: Treatment (Day 1) up to participant's death, opposition to data collection, or study termination (up to Year 6)
OS will be calculated as the interval between treatment administration and the date of death for any cause, opposition to data collection, or study termination, whichever occurs first.
QoL Measurements Using FACT-HEP Questionnaire Before and After Treatment
时间窗: Treatment (Day 1), every 2 to 4 months Post Treatment (maximum treatment time = up to Day 28), and SOC visits after Month 12 until up to participant's death, opposition to data collection, study withdraw for any cause, or study termination (up to Year 6)
Quality of Life (QoL) will be assessed by the Functional Assessment of Cancer Therapy (FACT-HEP) questionnaire prior to treatment on Day 1, every 2 to 4 months post treatment (follow up visits), and every standard of care (SOC) visit after Month 12 until the participant's death, opposition to data collection, study withdraw for any cause, or study termination. The FACT-Hep Questionnaire uses participant-reported outcome (PRO) scores. QoL scores of each domain at each time-point and their differences from baseline will be summarised. A deterioration in QoL is defined as a 7-point decline in the total score or death, whichever comes first. The time to deterioration in QoL will be calculated as the interval between first date of TheraSphere® treatment and deterioration in QoL. The higher the score, the better the QoL, with a range 0-180.
次要结局
- Duration of Re-Hospitalisations Following Treatment(Treatment (Day 1) up to Month 1 Post Treatment (maximum treatment time = up to Day 28))
- Number of Participants with Tumour Response(Treatment (Day 1) up to Month 12 Post Treatment (maximum treatment time = up to Day 28))
- Number of Participants Reporting Best Supportive Care Treatment(Treatment (Day 1) up to participant's death, opposition to data collection, study withdraw for any cause, or study termination (up to Year 6))
- Number of Participants Re-Hospitalised Following Treatment(Treatment (Day 1) up to Month 1 Post Treatment (maximum treatment time = up to Day 28))
- Description of Portal Vein Thrombosis (PVT) targeting by determination of the number of patients with PVT at baseline that have the PVT targeted by 99mTc-MAA (SPECT or SPECT/CT), Y-90 (PET/CT or PET/MRI or SPECT/CT).(Pre-Treatment Administration (Baseline) and Post-Treatment Administration (up to Day 28))
- Number of Participants Receiving a Post TheraSphere Anti-Cancer Treatment(Treatment (Day 1) up to participant's death, opposition to data collection, study withdraw for any cause, or study termination (up to Year 6))
- Number of Grade 3 or Higher Adverse Events (AEs) Related to Study treatment or Procedure(Treatment (Day 1) up to 90 Days Post Treatment or the first post treatment follow-up visit after TheraSphere administration, if after 90 days (maximum treatment time = up to Day 28))
- Number of Participants Achieving Treatment Expectation(Baseline up to Month 12 Post Treatment)
- Number of Participants with an Alpha-Fetoprotein (AFP), CA 19-9, CEA tumour Response(Treatment (Day 1) and Month 12 Post Treatment (maximum treatment time = up to Day 28))
- Determination of a correlation between tumour and normal tissue liver absorbed doses, determined with Y-90 (PET/CT or PET/MRI), with qualitative tumour response (CR or PR), OS and safety, respectively.(Baseline and Post 99mTc-MAA Imaging (up to Day 28))
- Number of Participants per Type of Vascular Access Used to Administer TheraSphere(Treatment (Day1) upto Month 12)
- Number of Participants with similar Tumour(s) Location at Baseline and the location of lesions targeted by 99mTc-MAA SPECT Imaging(Baseline and Post 99mTc-MAA Imaging (up to Day 28))
- Description of post treatment tumour targeting by determination of the number of patients with similar tumour(s) location at baseline and location of lesions targeted by Y-90 Positron Emission Tomography (PET)/CT or Y-90 PET/MRI or Y-90 SPECT/CT.(Baseline and Post TheraSphere Administration Imaging (up to Day 28))
- Determination of a correlation between tumour and normal tissue liver absorbed doses, determined with 99mTc-MAA (SPECT or SPECT/CT), with qualitative tumour response (CR or PR), OS and safety, respectively as Assessed by Cox Regression Analyses(Baseline and Post 99mTc-MAA Imaging (up to Day 28))
- Determination of a correlation between Dose volume histogram (DVH) for total perfused tumour, Index lesion and whole normal liver tissue, using 99mTc-MAA (SPECT or SPECT/CT) and Y-90 (PET/CT or PET/MRI).(Baseline and Post 99mTc-MAA Imaging (up to Day 28))
- Description of pre and post treatment tumour targeting by determination of the number of patients with similar tumour(s) location based on 99mTc-MAA (SPECT or SPECT/CT and location of tumour targeted by Y-90 using post-treatment(PET/CT or PET/MRI or SPEC(Pre-Treatment Administration (Baseline) and Post-Treatment Administration (up to Day 28))
- Determination of a correlation between tumour and normal tissue liver absorbed doses determined with 99mTc-MAA (SPECT or SPECT/CT) and with Y-90 (PET/CT or PET/MRI)(Baseline and Post 99mTc-MAA Imaging (up to Day 28))