RecruitingPhase 3NCT04290663

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

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


Sponsor

Centre Francois Baclesse

Enrollment

476 participants

Start Date

Mar 2, 2020

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is for patients with a specific intermediate-risk type of thyroid cancer after their thyroid has been surgically removed. It compares two approaches: giving all patients radioactive iodine treatment automatically versus only treating patients based on a follow-up test after surgery. The goal is to see if the second approach is just as safe while avoiding unnecessary treatment. **You may be eligible if...** - You have been diagnosed with differentiated thyroid cancer (papillary or follicular type) at an intermediate-risk level - Your cancer meets specific size, spread, and lymph node criteria - You have had your thyroid removed **You may NOT be eligible if...** - Your thyroid cancer is low-risk or high-risk (not intermediate) - Your cancer has an aggressive subtype - You have contraindications to radioactive iodine treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSystematic 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

OTHERDecision 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

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NCT04290663


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