Non-Interventional Registry Study to Evaluate the Effectiveness of TheraSphere® in the Treatment of Hepatocellular Carcinoma (HCC)
PROACTIF
A Prospective, Post Approval, Multiple Centre, Open-Label, Non-Interventional, Registry Study to Evaluate Effectiveness of TheraSphere® in Clinical Practice in France
1 other identifier
observational
1,247
1 country
37
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2019
Longer than P75 for all trials
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 13, 2019
CompletedFirst Submitted
Initial submission to the registry
August 22, 2019
CompletedFirst Posted
Study publicly available on registry
August 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedJuly 23, 2025
June 1, 2025
5.8 years
August 22, 2019
July 21, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Overall Survival (OS)
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.
Treatment (Day 1) up to participant's death, opposition to data collection, or study termination (up to Year 6)
QoL Measurements Using FACT-HEP Questionnaire Before and After Treatment
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.
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 (17)
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 Re-Hospitalised Following Treatment
Treatment (Day 1) up to Month 1 Post Treatment (maximum treatment time = up to Day 28)
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 Achieving Treatment Expectation
Baseline up to Month 12 Post Treatment
Number of Participants with Tumour Response
Treatment (Day 1) up to Month 12 Post Treatment (maximum treatment time = up to Day 28)
- +12 more secondary outcomes
Study Arms (1)
TheraSphere®
Patients with HCC, iCC and mCRC will be treated. TheraSphere is administered in the liver through the hepatic artery. Treatment will be performed according to the Instructions for Use (IFU). Activity of administered TheraSphere is tailored in order to deliver an absorbed dose of 80 to150 gray (Gy) to the liver. Lung dose (D) will be calculated from the following formula: D=A\*(1-S)\*50/1. D=Planned dose absorbed by treated volume(Gy), A=Activity injected with microspheres (gigabequerel \[GBq\]), S=Percentage of pulmonary shunt, "1" assuming that the lung mass=1 kilograms \[kg\]). Number of treatments is up to Investigator's discretion while taking into account the cumulative dose to the liver and lung.
Interventions
Participants will receive treatment with TheraSphere in accordance with Instructions for Use
Eligibility Criteria
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.
You may qualify if:
- Participant has received a reimbursed dose of TheraSphere®
- Participant does not oppose to the collection of his/her medical personal data
You may not qualify if:
- Participant has opposed to data collection
- Participant has not received a reimbursed dose of TheraSphere® (free of charge dose)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Boston Scientific Corporationlead
- Biocompatibles UK Ltdcollaborator
Study Sites (37)
CHU Amiens
Amiens, France
CHU, Angers
Angers, France
CHU Jean Minjoz
Besançon, France
Institut Bergonié
Bordeaux, 33000, France
Hôpital Haut Leveque
Bordeaux, France
Centre Hospitalier Régional et Universitaire de Brest
Brest, 29609, France
Hôpital Henri Mondor
Créteil, 76038, France
Centre George-Francois Leclerc
Dijon, France
CHU Dijon Bourgogne
Dijon, France
CHU Michallon
Grenoble, France
Bicêtre Hôpital
Le Kremlin-Bicêtre, 94275, France
CHU Lille
Lille, France
Centre Leon Berard
Lyon, France
Hopital de la Croix-Rousse
Lyon, France
Hopital Edouard Herriot
Lyon, France
CHU de la Timone
Marseille, France
Institut Paoli Calmettes
Marseille, France
CHU Saint Eloi
Montpellier, France
CHU Brabois Adultes
Nancy, France
CHU Site Hotel Dieu
Nantes, France
CHU de l'Archet
Nice, France
CHU de Nîmes, Hôpital Carremeau
Nîmes, France
Hopital Beaujon
Paris, France
Hôpital Cochin, APHP
Paris, France
Hôpital Saint-Louis
Paris, France
Centre Hospitalier de Perpignan
Perpignan, 66046, France
Hopital Lyon Sud
Pierre-Bénite, France
CHU La Milétrie
Poitiers, France
Centre Eugene Marquis
Rennes, France
Centre Henri Becquerel
Rouen, France
CHU Rouen
Rouen, France
Centre Hospitalier Universitaire de St Etienne
Saint-Priest-en-Jarez, France
CHU deHautepierre
Strasbourg, France
Nouvel Hopital Civil
Strasbourg, France
CHU Rangueil
Toulouse, France
Hopital Paul Brousse
Villejuif, 94800, France
Intstitut Gustave Roussy
Villejuif, 94805, France
Related Publications (1)
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.
PMID: 34796373DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2019
First Posted
August 28, 2019
Study Start
March 13, 2019
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
July 23, 2025
Record last verified: 2025-06