Clinical trial NCT04069468: Non-Interventional Registry Study to Evaluate the Effectiveness of TheraSphere® in the Treatment of Hepatocellular Carcinoma (HCC)
Official title: A Prospective, Post Approval, Multiple Centre, Open-Label, Non-Interventional, Registry Study to Evaluate Effectiveness of TheraSphere® in Clinical Practice in France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Keywords: Prospective Registry
TheraSphere®
France
SIRT
Liver Cancer, Adult
Liver Cell Carcinoma
Hepatoma
Intra arterial treatment
Intra hepatic Cholangiocarcinoma
Colon cancer metastasis
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
Collaborators: name: Biocompatibles UK Ltd
First posted: 2019-08-28
Enrollment: 1247
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All participants for whom treatment with TheraSphere® has been prescribed and reimbursed in France will be eligible for this study. It is estimated that data from \>500 participants will be entered into this registry from approximately 30 sites in France.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion:

* Participant has received a reimbursed dose of TheraSphere®
* Participant does not oppose to the collection of his/her medical personal data

Exclusion:

* Participant has opposed to data collection
* Participant has not received a reimbursed dose of TheraSphere® (free of charge dose)

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Treatment (Day 1) up to participant's death, opposition to data collection, or study termination (up to Year 6)
measure: QoL Measurements Using FACT-HEP Questionnaire Before and After Treatment
timeFrame: 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)
Secondary outcomes:
measure: Number of Grade 3 or Higher Adverse Events (AEs) Related to Study treatment or Procedure
timeFrame: 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)
measure: Number of Participants Re-Hospitalised Following Treatment
timeFrame: Treatment (Day 1) up to Month 1 Post Treatment (maximum treatment time = up to Day 28)
measure: Duration of Re-Hospitalisations Following Treatment
timeFrame: Treatment (Day 1) up to Month 1 Post Treatment (maximum treatment time = up to Day 28)
measure: Number of Participants Achieving Treatment Expectation
timeFrame: Baseline up to Month 12 Post Treatment
measure: Number of Participants with Tumour Response
timeFrame: Treatment (Day 1) up to Month 12 Post Treatment (maximum treatment time = up to Day 28)
measure: Number of Participants with an Alpha-Fetoprotein (AFP), CA 19-9, CEA tumour Response
timeFrame: Treatment (Day 1) and Month 12 Post Treatment (maximum treatment time = up to Day 28)
measure: Number of Participants Receiving a Post TheraSphere Anti-Cancer Treatment
timeFrame: Treatment (Day 1) up to participant's death, opposition to data collection, study withdraw for any cause, or study termination (up to Year 6)
measure: Number of Participants Reporting Best Supportive Care Treatment
timeFrame: Treatment (Day 1) up to participant's death, opposition to data collection, study withdraw for any cause, or study termination (up to Year 6)
measure: Number of Participants per Type of Vascular Access Used to Administer TheraSphere
timeFrame: Treatment (Day1) upto Month 12
measure: Number of Participants with similar Tumour(s) Location at Baseline and the location of lesions targeted by 99mTc-MAA SPECT Imaging
timeFrame: Baseline and Post 99mTc-MAA Imaging (up to Day 28)
measure: 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.
timeFrame: Baseline and Post TheraSphere Administration Imaging (up to Day 28)
measure: 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
timeFrame: Pre-Treatment Administration (Baseline) and Post-Treatment Administration (up to Day 28)
measure: 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).
timeFrame: Pre-Treatment Administration (Baseline) and Post-Treatment Administration (up to Day 28)
measure: 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
timeFrame: Baseline and Post 99mTc-MAA Imaging (up to Day 28)
measure: 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.
timeFrame: Baseline and Post 99mTc-MAA Imaging (up to Day 28)
measure: 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)
timeFrame: Baseline and Post 99mTc-MAA Imaging (up to Day 28)
measure: 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).
timeFrame: Baseline and Post 99mTc-MAA Imaging (up to Day 28)
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
city: Angers
country: France
facility: CHU, Angers
city: Besançon
country: France
facility: CHU Jean Minjoz
city: Bordeaux
country: France
facility: Institut Bergonié
city: Bordeaux
country: France
facility: Hôpital Haut Leveque
city: Brest
country: France
facility: Centre Hospitalier Régional et Universitaire de Brest
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Dijon
country: France
facility: Centre George-Francois Leclerc
city: Dijon
country: France
facility: CHU Dijon Bourgogne
city: Grenoble
country: France
facility: CHU Michallon
city: Le Kremlin-Bicêtre
country: France
facility: Bicêtre Hôpital
city: Lille
country: France
facility: CHU Lille
city: Lyon
country: France
facility: Centre Leon Berard
city: Lyon
country: France
facility: Hopital de la Croix-Rousse
city: Lyon
country: France
facility: Hopital Edouard Herriot
city: Marseille
country: France
facility: CHU de la Timone
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Montpellier
country: France
facility: CHU Saint Eloi
city: Nancy
country: France
facility: CHU Brabois Adultes
city: Nantes
country: France
facility: CHU Site Hotel Dieu
city: Nice
country: France
facility: CHU de l'Archet
city: Nîmes
country: France
facility: CHU de Nîmes, Hôpital Carremeau
city: Paris
country: France
facility: Hopital Beaujon
city: Paris
country: France
facility: Hôpital Cochin, APHP
city: Paris
country: France
facility: Hôpital Saint-Louis
city: Perpignan
country: France
facility: Centre Hospitalier de Perpignan
city: Pierre Benite
country: France
facility: Hopital Lyon Sud
city: Poitiers
country: France
facility: CHU La Milétrie
city: Rennes
country: France
facility: Centre Eugene Marquis
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Rouen
country: France
facility: CHU Rouen
city: Saint-Priest-en-Jarez
country: France
facility: Centre Hospitalier Universitaire de St Etienne
city: Strasbourg
country: France
facility: CHU deHautepierre
city: Strasbourg
country: France
facility: Nouvel Hopital Civil
city: Toulouse
country: France
facility: CHU Rangueil
city: Villejuif
country: France
facility: Hopital Paul Brousse
city: Villejuif
country: France
facility: Intstitut Gustave Roussy
Study officials:
References:
citation: Garin E, Pinaquy JB, Bailly C, Sengel C, Mariano-Goulart D, Edeline J, Blanc JF, Bouvier A, Tordo J, Rode A, Becker S, Sefrioui D, de Baere T, Somma C, Mastier C, Goupil J, Chevallier P, Regnault H, Vibert E, Manfredi S, Vicaut E, Patel B, Boucher E, Guiu B; PROACTIF registry group. Evaluating the Effectiveness of Yttrium-90 Glass Microspheres in the Treatment of Hepatocellular Carcinoma, Intrahepatic Cholangiocarcinoma, and Metastatic Colorectal Cancer in Practice: Protocol for the Prospective PROACTIF Phase IV Registry Study in France. Cardiovasc Intervent Radiol. 2022 Jan;45(1):1-11. doi: 10.1007/s00270-021-03002-0. Epub 2021 Nov 18.