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RECRUITINGPhase 3INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form form - Patient who agrees to be followed annually during 5 years - Patient affiliated to the French social security system Who Should NOT Join This Trial: - • 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) ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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

Locations (20)

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