Systematic Radioiodine Administration Versus Decision of Radioiodine Treatment Guided by a Post-operative Work-up
NCT ID: NCT04290663
Last Updated: 2025-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
476 participants
INTERVENTIONAL
2020-03-02
2033-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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RAI group
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
GUIDED FOLLOW-UP group
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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French cancer Institute INCa
UNKNOWN
Centre Francois Baclesse
OTHER
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Suzy DUFLO, Prof
Role: primary
Patrice RODIEN, MD
Role: primary
Olivier MOREL, MD
Role: primary
Yann GODBERT, MD
Role: primary
Bogdan NICOLESCU-CATARGI, Prof
Role: primary
Nathalie ROUDAUT, MD
Role: primary
Stéphane BARDET, MD
Role: primary
Jean-Cyril BOURRE, MD
Role: primary
Clémence VALLA, MD
Role: primary
Inna DYGAI-COCHET, MD
Role: primary
Soizic MASSON, MD
Role: primary
Julie ROUX, MD
Role: primary
Christine DO CAO, MD
Role: primary
Anne-Laure GIRAUDET, MD
Role: primary
Solène CASTELLNOU, MD
Role: primary
David TAIEB, Prof
Role: primary
Catherine Ansquer, MD
Role: primary
Danielle BENISVY, MD
Role: primary
Olivier GILLY, MD
Role: primary
Charlotte LUSSEY-LEPOUTRE, MD
Role: primary
Mohamad ZALZALI, MD
Role: primary
Agathe EDET-SANSON, MD
Role: primary
RICHARD Capucine, MD
Role: primary
Danièla RUSU, MD
Role: primary
Olivier SCHNEEGANS, MD
Role: primary
Solange GRUNENWALD, MD
Role: primary
Camila NASCIMENTO, MD
Role: primary
Livia LAMARTINA, MD
Role: primary
Other Identifiers
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2019-002968-27
Identifier Type: -
Identifier Source: org_study_id
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