• Differentiated Thyroid Cancer: is There a Need for Radioiodine Ablation in Low Risk Patients?

  NCT01837745

  Active, not recruitingInterventionalPhase 3Updated May 17, 2023
• The Safety and Effectiveness of rhTSH in Radioiodine Treatment for Patients With Differentiated Thyroid Cancer.

  NCT04447183

  Unknown statusInterventionalPhase 2Updated Oct 23, 2023
• Decision Making on Radioactive Iodine Treatment for Papillary Thyroid Cancer

  NCT01083550

  CompletedInterventionalPhase 2Phase 3Updated Nov 29, 2016
• Use of a Decision Aid to Resolve Uncertainty About Radioactive Iodine Treatment in Patients With Intermediate Risk Thyroid Cancer

  NCT06980103

  RecruitingInterventionalNot ApplicableUpdated Jan 8, 2026
• Post-RAI Therapy Dosimetry and Quality Assessment of Target Tissue Dosing

  NCT06028282

  Unknown statusObservationalUpdated Dec 11, 2023
• Medico-Economic Comparison of Four Strategies of Radioiodine Ablation in Thyroid Carcinoma Patients

  NCT00435851

  Unknown statusInterventionalPhase 3Updated Feb 19, 2007

ClinicalTrials.gov ID

NCT04290663

Lead Sponsor

Centre Francois BaclesseOTHER

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 3

Enrollment

368Estimated

Last Update Posted

Jun 25, 2026Actual

Start Date

Mar 2, 2020Actual

Primary Completion Date

Feb 2031Estimated

Completion Date

Feb 2033Estimated

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

Brief 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

• Thyroid Cancer
• Intermediate Risk

• Systematic RAI-treatment
• Decision of RAI-treatment guided by a post-operative assessment

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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 Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Centre Francois BaclesseOTHER

Collaborators

French cancer Institute INCaUNKNOWN

p.raymond@chru-nancy.fr