Systematic Radioiodine Administration Versus Decision of Radioiodine Treatment Guided by a Post-operative Work-up

PHASE3RecruitingINTERVENTIONAL
Enrollment

476

Participants

Timeline

Start Date

March 2, 2020

Primary Completion Date

February 28, 2031

Study Completion Date

February 28, 2033

Conditions
Thyroid CancerIntermediate Risk
Interventions
DRUG

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

OTHER

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"

Trial Locations (29)

Unknown

NOT_YET_RECRUITING

CHU Pointe à pitre, Pointe à Pitre

RECRUITING

Chu Angers, Angers

RECRUITING

Institu de Cancérologie de l'Ouest - Site Angers, Angers

RECRUITING

Bergonié, Bordeaux

RECRUITING

Hôpital saint-André, Bordeaux

RECRUITING

Chu Brest, Brest

RECRUITING

Centre Francois Baclesse, Caen

RECRUITING

Centre Hospitalier Métropôle Savoie, Chambéry

RECRUITING

Centre Jean Perrin, Clermont-Ferrand

RECRUITING

Centre Georges-François Leclerc, Dijon

RECRUITING

Chu Martinique, Fort de France

RECRUITING

Chu Grenoble, Grenoble

RECRUITING

Chru Lille, Lille

RECRUITING

Centre Léon Bérard, Lyon

RECRUITING

Hospices Civils de Lyon, Lyon

RECRUITING

CHU Timone, Marseille

RECRUITING

Chu Nancy, Nancy

RECRUITING

Chu Nantes, Nantes

RECRUITING

Centre Antoine Lacassagne -, Nice

RECRUITING

Chu Nimes, Nîmes

RECRUITING

AP-HP Pitié Salpétrière, Paris

RECRUITING

Centre Jean Godinot, Reims

RECRUITING

Centre Henri Becquerel, Rouen

RECRUITING

Institut CURIE, site Réné Huguenin, Saint-Cloud

RECRUITING

Institu de Cancérologie de l'Ouest - Site St Herblain, Saint-Herblain

RECRUITING

Centre Paul Strauss, Strasbourg

RECRUITING

CHU TOULOUSE, Hôpital Larrey, Toulouse

RECRUITING

IUCT Oncopole, Toulouse

RECRUITING

Institut Gustave Roussy, Villejuif

All Listed Sponsors
collaborator

French cancer Institute INCa

UNKNOWN

lead

Centre Francois Baclesse

OTHER

NCT04290663 - Systematic Radioiodine Administration Versus Decision of Radioiodine Treatment Guided by a Post-operative Work-up | Biotech Hunter | Biotech Hunter