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Clinical Trials in France / NCT04290663
Recruiting Phase 3

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

NCT04290663 · tracked via the Priya Life Science France tracker
Phase
Phase 3
Started
2020-03-02
Last updated
2026-06-25

Condition(s) studied

Thyroid CancerIntermediate Risk

Investigational drug(s) / intervention(s)

Systematic RAI-treatmentDecision of RAI-treatment guided by a post-operative assessment

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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 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

Primary outcome measure(s)

Trial sites (29)

FacilityCityRegionStatus
CHU Pointe à pitre Pointe à Pitre Guadeloupe Not Yet Recruiting
Chu Angers Angers France Recruiting
Institu de Cancérologie de l'Ouest - Site Angers Angers France Recruiting
Bergonié Bordeaux France Recruiting
Hôpital saint-André Bordeaux France Recruiting
Chu Brest Brest France Recruiting
Centre Francois Baclesse Caen France Recruiting
Centre Hospitalier Métropôle Savoie Chambéry France Recruiting
Centre Jean Perrin Clermont-Ferrand France Recruiting
Centre Georges-François Leclerc Dijon France Recruiting
Chu Martinique Fort de France France Recruiting
Chu Grenoble Grenoble France Recruiting
Chru Lille Lille France Recruiting
Centre Léon Bérard Lyon France Recruiting
Hospices Civils de Lyon Lyon France Recruiting
CHU Timone Marseille France Recruiting
Chu Nancy Nancy France Recruiting
Chu Nantes Nantes France Recruiting
Centre Antoine Lacassagne - Nice France Recruiting
Chu Nimes Nîmes France Recruiting
AP-HP Pitié Salpétrière Paris France Recruiting
Centre Jean Godinot Reims France Recruiting
Centre Henri Becquerel Rouen France Recruiting
Institut CURIE, site Réné Huguenin Saint-Cloud France Recruiting
Institu de Cancérologie de l'Ouest - Site St Herblain Saint-Herblain France Recruiting
Centre Paul Strauss Strasbourg France Recruiting
CHU TOULOUSE, Hôpital Larrey Toulouse France Recruiting
IUCT Oncopole Toulouse France Recruiting
Institut Gustave Roussy Villejuif France Recruiting

More Centre Francois Baclesse trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04290663 on ClinicalTrials.gov ↗ ← All trials in France