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Thyroid CancerPhase 3INTERMEDIATENCT04290663

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

A Phase 3 study testing Systematic RAI-treatment and Decision of RAI-treatment guided by a post-operative assessment in people with Thyroid Cancer and Intermediate Risk, run by Centre Francois Baclesse at 29 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thyroid Cancer, Intermediate Risk
What is being tested?
Systematic RAI-treatment and Decision of RAI-treatment guided by a post-operative assessment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
368 participants
Where
29 sitesFrance
Study dates
2 Mar 2020to Feb 2033
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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

Who cannot join

  • • 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)
Show all 24Show fewer
  • 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

Trial locations and contacts

29 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Renaud CIAPPUCCINI, MD contact

(33)231455050

r.ciappuccini@baclesse.unicancer.fr

29 sites in 1 country

France29 sites, 29 recruiting

  • Chu Angers

    Angers

    Patrice RODIEN, MD

    Recruiting

  • Institu de Cancérologie de l'Ouest - Site Angers

    Angers

    Olivier MOREL, MD

    Recruiting

  • Bergonié

    Bordeaux

    Yann GODBERT, MD

    Recruiting

  • Hôpital saint-André

    Bordeaux

    Bogdan NICOLESCU-CATARGI, Prof

    Recruiting

  • Chu Brest

    Brest

    Nathalie ROUDAUT, MD

    Recruiting

  • Centre Francois Baclesse

    Caen

    Renaud CIAPPUCCINI, MD, (33)231455050, r.ciappuccini@baclesse.unicancer.fr

    Recruiting

  • Centre Hospitalier Métropôle Savoie

    Chambéry

    Jean-Cyril BOURRE, MD

    Recruiting

  • Centre Jean Perrin

    Clermont-Ferrand

    Clémence VALLA, MD

    Recruiting

  • Centre Georges-François Leclerc

    Dijon

    Inna DYGAI-COCHET, MD

    Recruiting

  • Chu Martinique

    Fort de France

    Soizic MASSON, MD

    Recruiting

  • Chu Grenoble

    Grenoble

    Julie ROUX, MD

    Recruiting

  • Chru Lille

    Lille

    Christine DO CAO, MD

    Recruiting

  • Centre Léon Bérard

    Lyon

    Anne-Laure GIRAUDET, MD

    Recruiting

  • Hospices Civils de Lyon

    Lyon

    Solène CASTELLNOU, MD

    Recruiting

  • CHU Timone

    Marseille

    David TAIEB, Prof

    Recruiting

  • Chu Nancy

    Nancy

    Perrine RAYMOND, prof, p.raymond@chru-nancy.fr

    Recruiting

  • Chu Nantes

    Nantes

    Catherine Ansquer, MD

    Recruiting

  • Centre Antoine Lacassagne -

    Nice

    Danielle BENISVY, MD

    Recruiting

  • Chu Nimes

    Nîmes

    Olivier GILLY, MD

    Recruiting

  • AP-HP Pitié Salpétrière

    Paris

    Charlotte LUSSEY-LEPOUTRE, MD

    Recruiting

  • CHU Pointe à pitre

    Pointe à Pitre, Guadeloupe

    Suzy DUFLO, Prof

    Not yet recruiting

  • Centre Jean Godinot

    Reims

    Mohamad ZALZALI, MD

    Recruiting

  • Centre Henri Becquerel

    Rouen

    Agathe EDET-SANSON, MD

    Recruiting

  • Institut CURIE, site Réné Huguenin

    Saint-Cloud

    RICHARD Capucine, MD

    Recruiting

  • Institu de Cancérologie de l'Ouest - Site St Herblain

    Saint-Herblain

    Danièla RUSU, MD

    Recruiting

  • Centre Paul Strauss

    Strasbourg

    Olivier SCHNEEGANS, MD

    Recruiting

  • CHU TOULOUSE, Hôpital Larrey

    Toulouse

    Solange GRUNENWALD, MD

    Recruiting

  • IUCT Oncopole

    Toulouse

    Camila NASCIMENTO, MD

    Recruiting

  • Institut Gustave Roussy

    Villejuif

    Livia LAMARTINA, MD

    Recruiting

Other trials in France

About this study

Official title: 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

Being tested
Systematic RAI-treatment, Decision of RAI-treatment guided by a post-operative assessment
Keywords
radioiodine, I131
Medical subject headings
Thyroid Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Systematic RAI-treatmentDrug

    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 assessmentOther

    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 groups in NCT04290663
Study groupRoleWhat they receive
RAI groupActive comparatorNot described
Receives: Drug: Systematic RAI-treatment
GUIDED FOLLOW-UP groupExperimentalNot described
Receives: Other: Decision of RAI-treatment guided by a post-operative assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the rate of patients with excellent tumoral response

    normal neck ultrasonography and Tg/LT4 <0.2 ng/mL and absence of TgAb and if performed, no abnormalities on other imaging modalities

    Measured: 36 months after randomization

Secondary outcomes (4)

  1. Patient's quality-of-life

    Comparison of the scores on SF-36 (score between 0 and 100) between 2 arms

    Measured: During I131 treatment and at 1 and 3 years

  2. Salivary, nasal and lachrymal toxicities

    Comparison of the intensity of salivary, nasal and lachrymal toxicities between 2 arms

    Measured: During I131 treatment and at 1,2,3 and 5 years

  3. Management cost

    Costs of all medical exams and transportation related to the care within 5 years post-randomization in both groups

    Measured: through study completion, an average of 5 years

  4. Patient's anxiety

    Comparison of the scores on STAI questionnaire (score between 20 and 80) between 2 arms

    Measured: During I131 treatment and at 1 and 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2020
  2. Study start2 Mar 2020
  3. Primary completionFeb 2031 (estimated)
  4. Study completionFeb 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
368 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04290663
Sponsor's protocol ID
2019-002968-27
Other IDs
2019
Acronym
INTERMEDIATE
Status last verified
Jun 2026
First submitted
20 Feb 2020
Last updated
25 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Systematic RAI-treatment and Decision of RAI-treatment guided by a post-operative assessment in people with Thyroid Cancer and Intermediate Risk, run by Centre Francois Baclesse at 29 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Renaud CIAPPUCCINI, MD ((33)231455050, r.ciappuccini@baclesse.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the rate of patients with excellent tumoral response (time frame: 36 months after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04290663.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.

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