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Systematic Radioiodine Administration Versus Decision of Radioiodine Treatment Guided by a Post-operative Work-up
Sponsor: Centre Francois Baclesse
Summary
This trial is comparing two strategies in intermediate-risk differentiated thyroid cancer patients: Systematic radioiodine administration versus decision of radioiodine treatment guided by a post-operative work-up based on serum Tg values and diagnostic RAI scintigraphy
Official title: Multicentric Phase III Trial Comparing Two Strategies in Intermediate-risk Differentiated Thyroid Cancer Patients: Systematic Radioiodine Administration Versus Decision of Radioiodine Treatment Guided by a Post-operative Work-up Based on Serum Tg Values and Diagnostic RAI Scintigraphy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
476
Start Date
2020-03-02
Completion Date
2033-02
Last Updated
2025-10-14
Healthy Volunteers
No
Conditions
Interventions
Systematic RAI-treatment
Administration of 3.7 GBq (100 mCi) or 1,1 GBq (30 mCi) of I131 at the choice of the investigator after rhTSH-stimulation
Decision of RAI-treatment guided by a post-operative assessment
The decision-making for the administration of an adapted RAI-treatment will be taken according to the following criteria: * No RAI treatment if Tg/LT4 ≤1 ng/mL and rhTSH-sTg ≤10 ng/mL and normal diagnostic RAI-scintigraphy * 1.1 GBq after rhTSH if Tg/LT4\>1 ng/mL or rhTSH-sTg\>10 ng/mL and normal diagnostic RAI-scintigraphy. * 3.7 GBq after rhTSH if metastatic lymph-node(s) detected on diagnostic RAI-scintigraphy without distant metastasis * 3.7 GBq after hormone withdrawal if distant metastasis detected on diagnostic RAI-scintigraphy or on the hybrid CT scan of the SPECT-CT acquisition
Locations (29)
CHU Pointe à pitre
Pointe à Pitre, Guadeloupe, France
Chu Angers
Angers, France
Institu de Cancérologie de l'Ouest - Site Angers
Angers, France
Bergonié
Bordeaux, France
Hôpital saint-André
Bordeaux, France
Chu Brest
Brest, France
Centre Francois Baclesse
Caen, France
Centre Hospitalier Métropôle Savoie
Chambéry, France
Centre Jean Perrin
Clermont-Ferrand, France
Centre Georges-François Leclerc
Dijon, France
Chu Martinique
Fort de France, France
Chu Grenoble
Grenoble, France
Chru Lille
Lille, France
Centre Léon Bérard
Lyon, France
Hospices Civils de Lyon
Lyon, France
CHU Timone
Marseille, France
Chu Nancy
Nancy, France
Chu Nantes
Nantes, France
Centre Antoine Lacassagne -
Nice, France
Chu Nimes
Nîmes, France
AP-HP Pitié Salpétrière
Paris, France
Centre Jean Godinot
Reims, France
Centre Henri Becquerel
Rouen, France
Institut CURIE, site Réné Huguenin
Saint-Cloud, France
Institu de Cancérologie de l'Ouest - Site St Herblain
Saint-Herblain, France
Centre Paul Strauss
Strasbourg, France
CHU TOULOUSE, Hôpital Larrey
Toulouse, France
IUCT Oncopole
Toulouse, France
Institut Gustave Roussy
Villejuif, France