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 (INTERMEDIATE)
Interventional
Phase 3
Centre Francois Baclesse (Voir sur ClinicalTrials)
mars 2020
février 2033
29 juin 2024
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 | 04/09/2024 13:49:29 | 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 - France | Charlotte LUSSEY-LEPOUTRE, MD | Contact (sur clinicalTrials) | |||
| Bergonié - Bordeaux - France | Yann GODBERT, MD | Contact (sur clinicalTrials) | |||
| Centre Antoine Lacassagne - - Nice - France | Danielle BENISVY, MD | Contact (sur clinicalTrials) | |||
| Centre Francois Baclesse - Caen - France | Stéphane BARDET, MD | Contact (sur clinicalTrials) | |||
| Centre Georges-François Leclerc - Dijon - France | Inna DYGAI-COCHET, MD | Contact (sur clinicalTrials) | |||
| Centre Henri Becquerel - Rouen - France | Agathe EDET-SANSON, MD | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Métropôle Savoie - Chambéry - France | Jean-Cyril BOURRE, MD | Contact (sur clinicalTrials) | |||
| Centre Jean Godinot - Reims - France | Mohamad ZALZALI, MD | Contact (sur clinicalTrials) | |||
| Centre Jean Perrin - Clermont-Ferrand - France | Clémence VALLA, MD | Contact (sur clinicalTrials) | |||
| Centre Léon Bérard - Lyon - France | Anne-Laure GIRAUDET, MD | Contact (sur clinicalTrials) | |||
| Centre Paul Strauss - Strasbourg - France | Olivier SCHNEEGANS, MD | Contact (sur clinicalTrials) | |||
| Chru Lille - Lille - France | Christine DO CAO, MD | Contact (sur clinicalTrials) | |||
| Chu Angers - Angers - France | Patrice RODIEN, MD | Contact (sur clinicalTrials) | |||
| Chu Brest - Brest - France | Nathalie ROUDAUT, MD | Contact (sur clinicalTrials) | |||
| Chu Grenoble - Grenoble - France | Julie ROUX, MD | Contact (sur clinicalTrials) | |||
| Chu Lyon, - Lyon - France | Caroline MOREAU TRIBY, MD | Contact (sur clinicalTrials) | |||
| Chu Nancy - Nancy - France | Marc KLEIN, prof | Contact (sur clinicalTrials) | |||
| Chu Nantes - Nantes - France | Catherine Ansquer, MD | Contact (sur clinicalTrials) | |||
| Chu Nimes - Nîmes - France | Olivier GILLY, MD | Contact (sur clinicalTrials) | |||
| CHU Pointe à pitre - Pointe À Pitre - Guadeloupe - France | Suzy DUFLO, Prof | Contact (sur clinicalTrials) | |||
| CHU Timone - Marseille - France | David TAIEB, Prof | Contact (sur clinicalTrials) | |||
| CHU TOULOUSE, Hôpital Larrey - Toulouse - France | Solange GRUNENWALD, MD | Contact (sur clinicalTrials) | |||
| Hôpital saint-André - Bordeaux - France | Bogdan NICOLESCU-CATARGI, Prof | Contact (sur clinicalTrials) | |||
| Institu de Cancérologie de l'Ouest - Site Angers - Angers - France | Olivier MOREL, MD | Contact (sur clinicalTrials) | |||
| Institu de Cancérologie de l'Ouest - Site St Herblain - Saint-Herblain - France | Danièla RUSU, MD | Contact (sur clinicalTrials) | |||
| Institut CURIE, site Réné Huguenin - Saint-Cloud - France | RICHARD Capucine, MD | Contact (sur clinicalTrials) | |||
| IUCT Oncopole - Toulouse - France | Camila NASCIMENTO, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- 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
- 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
- • 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