Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 3
Centre Francois Baclesse (Voir sur ClinicalTrials)
mars 2020
février 2033
02 novembre 2025
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
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | 04/06/2024 14:01:24 | Contact (sur clinicalTrials) | |||
| CLCC INSTITUT GUSTAVE ROUSSY | Livia LAMARTINA | 22/02/2024 16:58:18 | Contacter | ||
| CLCC RENE HUGUENIN INSTITUT CURIE | 10/04/2025 13:11:58 | Contact (sur clinicalTrials) | |||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| INSTITUT GUSTAVE ROUSSY | Livia LAMARTINA, MD | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier Métropôle Savoie - Chambéry 3027422 - France | Jean-Cyril BOURRE, MD | Contact (sur clinicalTrials) | |||
| Centre Jean Godinot - Reims 2984114 - France | Mohamad ZALZALI, MD | Contact (sur clinicalTrials) | |||
| Centre Jean Perrin - Clermont-Ferrand 3024635 - France | Clémence VALLA, MD | Contact (sur clinicalTrials) | |||
| Centre Léon Bérard - Lyon 2996944 - France | Anne-Laure GIRAUDET, MD | Contact (sur clinicalTrials) | |||
| Centre Paul Strauss - Strasbourg 2973783 - France | Olivier SCHNEEGANS, MD | Contact (sur clinicalTrials) | |||
| Chu Nimes - Nîmes 2990363 - France | Olivier GILLY, MD | Contact (sur clinicalTrials) | |||
| Hôpital saint-André - Bordeaux 3031582 - France | Bogdan NICOLESCU-CATARGI, Prof | Contact (sur clinicalTrials) | |||
| Hospices Civils de Lyon - Lyon 2996944 - France | Solène CASTELLNOU, MD | Contact (sur clinicalTrials) | |||
| Institu de Cancérologie de l'Ouest - Site Angers - Angers 3037656 - France | Olivier MOREL, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP Pitié Salpétrière - Paris 2988507 - France | Charlotte LUSSEY-LEPOUTRE, MD | Contact (sur clinicalTrials) | |||
| Bergonié - Bordeaux 3031582 - France | Yann GODBERT, MD | Contact (sur clinicalTrials) | |||
| Centre Antoine Lacassagne - - Nice 2990440 - France | Danielle BENISVY, MD | Contact (sur clinicalTrials) | |||
| Centre Francois Baclesse - Caen 3029241 - France | Stéphane BARDET, MD | Contact (sur clinicalTrials) | |||
| Centre Georges-François Leclerc - Dijon 3021372 - France | Inna DYGAI-COCHET, MD | Contact (sur clinicalTrials) | |||
| Centre Henri Becquerel - Rouen 2982652 - France | Agathe EDET-SANSON, MD | Contact (sur clinicalTrials) | |||
| Chru Lille - Lille 2998324 - France | Christine DO CAO, MD | Contact (sur clinicalTrials) | |||
| Chu Angers - Angers 3037656 - France | Patrice RODIEN, MD | Contact (sur clinicalTrials) | |||
| Chu Brest - Brest 3030300 - France | Nathalie ROUDAUT, MD | Contact (sur clinicalTrials) | |||
| Chu Grenoble - Grenoble 3014728 - France | Julie ROUX, MD | Contact (sur clinicalTrials) | |||
| Chu Martinique - Fort De France - France | Soizic MASSON, MD | Contact (sur clinicalTrials) | |||
| Chu Nancy - Nancy 2990999 - France | Perrine RAYMOND, prof | Contact (sur clinicalTrials) | |||
| Chu Nantes - Nantes 2990969 - France | Catherine Ansquer, MD | Contact (sur clinicalTrials) | |||
| CHU Pointe à pitre - Pointe à Pitre 12164896 - Guadeloupe - France | Suzy DUFLO, Prof | Contact (sur clinicalTrials) | |||
| CHU Timone - Marseille 2995469 - France | David TAIEB, Prof | Contact (sur clinicalTrials) | |||
| CHU TOULOUSE, Hôpital Larrey - Toulouse 2972315 - France | Solange GRUNENWALD, MD | Contact (sur clinicalTrials) | |||
| Institu de Cancérologie de l'Ouest - Site St Herblain - Saint-Herblain 2979590 - France | Danièla RUSU, MD | Contact (sur clinicalTrials) | |||
| Institut CURIE, site Réné Huguenin - Saint-Cloud 2981041 - France | RICHARD Capucine, MD | Contact (sur clinicalTrials) | |||
| IUCT Oncopole - Toulouse 2972315 - France | Camila NASCIMENTO, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
- Subgroup of patients with differentiated thyroid cancer and intermediate-risk
defined as follows according to TNM 2017:
- Papillary thyroid cancer (PTC) without aggressive subtype, follicular thyroid
cancer (FTC) (with < 4 foci of vascular invasion) or Hürthle cell carcinoma
(HCC)
- T1b or T2 with minimal extra-thyroid extension into the perithyroidal soft
tissues and/or pN1 with largest nodal dimension between 2 and 10 mm, without
extra-capsular invasion and with a number of metastatic nodes ≤ 10
- T1aN1 with largest nodal dimension between 2 and 10 mm, without extra-capsular
invasion and with a number of metastatic nodes ≤ 10
- Patient treated by total thyroidectomy with macroscopically complete tumor resection
(R0 or R1) ± neck dissection
- Total thyroidectomy performed within 6 to 14 10 weeks before randomization
- Patient with or without anti-thyroglobulin antibodies (TgAb)
- No known distant metastases
- Normal post-operative neck ultrasound (US) or if doubtful US, negative cytology and
normal Tg value (<10 ng/ml) in FNA washout fluid
- Post-operative LT4 treatment initiated at least 6 weeks before randomization
- Performance Status 0 or 1
- Patients aged 18 years or older
- Signed informed consent form
- Patient who agrees to be followed annually during 5 years
- Patient affiliated to the French social security system
Exclusion Criteria:
- • Patients with:
- medullary or anaplastic thyroid cancer
- or poorly differentiated carcinoma
- or well differentiated FTC with at least more than 4 foci of vascular invasion
- or PTC with aggressive variants (tall cell or columnar cell carcinoma, diffuse
sclerosing papillary, hobnail variant)
- NIFTP (Noninvasive follicular thyroid neoplasm with papillary-like nuclear
features)
• Low-risk or high-risk DTC patients according to ATA 2015, and
intermediate-risk patients with extra-thyroid extension into the perithyroidal
muscles (pT3b according to pTNM 2017), and/or pN1 with nodal largest dimension
>10 mm or with extra-capsular invasion or more than 10 metastatic nodes. This
excludes the following patients:
- All pT1a, pT3 or pT4
- pT1aN0/x with or without minimal extra-thyroid extension
- pT1bN0/x, pT2N0/Nx without minimal extra-thyroid extension
- pT1aN1 or pT1bN1 or pT2N1 without extra-thyroid extension and with nodal
largest dimension <2mm
- pT1aN1 or pT1bN1 or pT2N1 without extra-thyroid extension and with nodal
largest dimension >10mm
- pT2N0/Nx without extra-thyroid extension
- pT2N1 without extra-thyroid extension and with nodal largest dimension <2mm
- pT2N1 without extra-thyroid extension and with nodal largest dimension >10mm
- Surgery considered as macroscopically incomplete (R2)
- Patients who have undergone lobectomy only
- Post-operative neck US with metastatic lymph-nodes confirmed by cytology
or by increased Tg (>10 ng/ml) in FNA washout fluid
- Drugs affecting thyroid function including iodinated contrast agents in
the 6 weeks prior to randomization. Amiodarone should have been stopped at
least 1 year before randomization.
- Previous RAI treatment for thyroid cancer
- Pregnant or lactating women
- Any associated geographical, social or psychopathological condition that
could compromise the patient's ability to participate in the study
- Patient deprived of liberty or placed under the authority of a tutor
- History of malignancy in the past 3 years, except skin cancer excluding
melanoma, carcinoma in situ of the cervix. Any other solid tumor or
lymphoma (without bone marrow involvement) must have been treated and not
have shown signs of recurrence for at least 3 years