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

October 10, 2025 updated by: Centre Francois Baclesse

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

476

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Angers, France
        • Recruiting
        • CHU Angers
        • Contact:
          • Patrice RODIEN, MD
      • Angers, France
        • Recruiting
        • Institu de Cancérologie de l'Ouest - Site Angers
        • Contact:
          • Olivier MOREL, MD
      • Bordeaux, France
        • Recruiting
        • Bergonié
        • Contact:
          • Yann GODBERT, MD
      • Bordeaux, France
        • Recruiting
        • Hôpital Saint-André
        • Contact:
          • Bogdan NICOLESCU-CATARGI, Prof
      • Brest, France
        • Recruiting
        • CHU Brest
        • Contact:
          • Nathalie ROUDAUT, MD
      • Caen, France
        • Recruiting
        • Centre Francois Baclesse
        • Contact:
          • Stéphane BARDET, MD
      • Chambéry, France
        • Recruiting
        • Centre Hospitalier Metropole Savoie
        • Contact:
          • Jean-Cyril BOURRE, MD
      • Clermont-Ferrand, France
        • Recruiting
        • Centre Jean Perrin
        • Contact:
          • Clémence VALLA, MD
      • Dijon, France
        • Recruiting
        • Centre Georges-Francois Leclerc
        • Contact:
          • Inna DYGAI-COCHET, MD
      • Fort de France, France
        • Recruiting
        • CHU Martinique
        • Contact:
          • Soizic MASSON, MD
      • Grenoble, France
        • Recruiting
        • CHU Grenoble
        • Contact:
          • Julie ROUX, MD
      • Lille, France
        • Recruiting
        • CHRU Lille
        • Contact:
          • Christine DO CAO, MD
      • Lyon, France
        • Recruiting
        • Centre Leon Berard
        • Contact:
          • Anne-Laure GIRAUDET, MD
      • Lyon, France
        • Recruiting
        • Hospices Civils de Lyon
        • Contact:
          • Solène CASTELLNOU, MD
      • Marseille, France
        • Recruiting
        • CHU Timone
        • Contact:
          • David TAIEB, Prof
      • Nancy, France
      • Nantes, France
        • Recruiting
        • CHU Nantes
        • Contact:
          • Catherine Ansquer, MD
      • Nice, France
        • Recruiting
        • Centre Antoine Lacassagne -
        • Contact:
          • Danielle BENISVY, MD
      • Nîmes, France
        • Recruiting
        • CHU Nîmes
        • Contact:
          • Olivier GILLY, MD
      • Paris, France
        • Recruiting
        • AP-HP Pitié Salpetrière
        • Contact:
          • Charlotte LUSSEY-LEPOUTRE, MD
      • Reims, France
        • Recruiting
        • Centre Jean Godinot
        • Contact:
          • Mohamad ZALZALI, MD
      • Rouen, France
        • Recruiting
        • Centre Henri Becquerel
        • Contact:
          • Agathe EDET-SANSON, MD
      • Saint-Cloud, France
        • Recruiting
        • Institut CURIE, site Réné Huguenin
        • Contact:
          • RICHARD Capucine, MD
      • Saint-Herblain, France
        • Recruiting
        • Institu de Cancérologie de l'Ouest - Site St Herblain
        • Contact:
          • Danièla RUSU, MD
      • Strasbourg, France
        • Recruiting
        • Centre Paul Strauss
        • Contact:
          • Olivier SCHNEEGANS, MD
      • Toulouse, France
        • Recruiting
        • CHU Toulouse, Hôpital Larrey
        • Contact:
          • Solange GRUNENWALD, MD
      • Toulouse, France
        • Recruiting
        • IUCT Oncopole
        • Contact:
          • Camila NASCIMENTO, MD
      • Villejuif, France
        • Recruiting
        • Institut Gustave Roussy
        • Contact:
          • Livia LAMARTINA, MD
    • Guadeloupe
      • Pointe à Pitre, Guadeloupe, France
        • Not yet recruiting
        • CHU Pointe à Pitre
        • Contact:
          • Suzy DUFLO, Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: RAI group
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
Experimental: GUIDED FOLLOW-UP group
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the rate of patients with excellent tumoral response
Time Frame: 36 months after randomization
normal neck ultrasonography and Tg/LT4 <0.2 ng/mL and absence of TgAb and if performed, no abnormalities on other imaging modalities
36 months after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient's quality-of-life
Time Frame: During I131 treatment and at 1 and 3 years
Comparison of the scores on SF-36 (score between 0 and 100) between 2 arms
During I131 treatment and at 1 and 3 years
Salivary, nasal and lachrymal toxicities
Time Frame: During I131 treatment and at 1,2,3 and 5 years
Comparison of the intensity of salivary, nasal and lachrymal toxicities between 2 arms
During I131 treatment and at 1,2,3 and 5 years
Management cost
Time Frame: through study completion, an average of 5 years
Costs of all medical exams and transportation related to the care within 5 years post-randomization in both groups
through study completion, an average of 5 years
Patient's anxiety
Time Frame: During I131 treatment and at 1 and 3 years
Comparison of the scores on STAI questionnaire (score between 20 and 80) between 2 arms
During I131 treatment and at 1 and 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Francois Baclesse

Collaborators

French cancer Institute INCa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2020

Primary Completion (Estimated)

February 1, 2031

Study Completion (Estimated)

February 1, 2033

Study Registration Dates

First Submitted

February 20, 2020

First Submitted That Met QC Criteria

February 28, 2020

First Posted (Actual)

March 2, 2020

Study Record Updates

Last Update Posted (Estimated)

October 14, 2025

Last Update Submitted That Met QC Criteria

October 10, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-002968-27

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Thyroid Cancer

Clinical Trials on Systematic RAI-treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jamaica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe