Multicentric phase III trial comparing two strategies in intermediate-risk differentiated thyroid cancer patients: Systematic radioiodine administration (3.7 GBq I131 after rhTSH) versus decision of radioiodine treatment guided by a post-operative work-up based on serum Tg values and diagnostic RAI scintigraphy

Phase 1

• Conditions: Differentiated thyroid cancer - subgroup of patients with intermediate risk of postoperative residual disease; MedDRA version: 21.1Level: PTClassification code 10066474Term: Thyroid cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-002968-27-FR
• Lead Sponsor: Centre François Baclesse

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-06
• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 476

Inclusion Criteria

•Subgroup of patients with differentiated thyroid cancer and intermediate-risk defined as follows according to TNM 2017:
oPapillary thyroid cancer (PTC) without aggressive subtype, follicular thyroid cancer (FTC) or Hürthle cell carcinoma (HCC)
oT1b 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 positive nodes = 5
•Patient treated by total thyroidectomy with complete tumor resection ± neck dissection
•Total thyroidectomy performed within 6 to 10 weeks before randomization
•Patient with or without anti-thyroglobulin antibodies (TgAb)
•No known distant metastases
•Normal post-operative neck 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 inclusion
•PS 0 or 1
•Patients aged 18 years or older
•Signed informed consent form
•Patient agreeing to be followed annually during 5 years
•Patient affiliated to the social security system

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 476
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 476

Exclusion Criteria

•Patients with:
omedullary or anaplastic thyroid cancer
oor poorly differentiated carcinoma
oor well differentiated FTC with more than 4 foci of vascular invasion
oor PTC with aggressive variants (tall cell or columnar cell carcinoma,diffuse sclerosing papillary, hobnail variant)
oNIFTP (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 5 positive nodes. This excludes the following patients:
oAll pT1a, pT3 or pT4
opT1bN0/x without extra-thyroid extension
opT1bN1 without extra-thyroid extension and with nodal largest dimension <2mm
opT1bN1 without extra-thyroid extension and with nodal largest dimension >10mm
opT2N0/Nx without extra-thyroid extension
opT2N1 without extra-thyroid extension and with nodal largest dimension <2mm
opT2N1 without extra-thyroid extension and with nodal largest dimension >10mm
oSurgery considered as incomplete
•Patients who have undergone lobectomy only
•Post-operative neck US with metastatic lymph-nodes proven cytologically or with increased Tg 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 show signs of recurrence for at least 3 years

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified