SODIUM IODIDE (131I) for Differentiated thyroid cancer | Papillary thyroid cancer | Follicular thyroid cancer

Inclusion criteria

• {"criterion_text":"-\tSubgroup of patients with differentiated thyroid cancer and intermediate-risk defined as follows according to TNM 2017: o\tPapillary thyroid cancer (PTC) without aggressive subtype, follicular thyroid cancer (FTC) (with < 4 foci of vascular invasion) or Hürthle cell carcinoma (HCC) o\tT1b 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 o\tT1aN1 with largest nodal dimension between 2 and 10 mm, without extra-capsular invasion and with a number of metastatic nodes ≤ 10"}
• {"criterion_text":"-\tSigned informed consent form"}
• {"criterion_text":"-\tPatient who agrees to be followed annually during 5 years"}
• {"criterion_text":"-\tPatient affiliated to the French social security system"}
• {"criterion_text":"-\tPatient treated by total thyroidectomy with macroscopically complete tumor resection (R0 or R1) ± neck dissection"}
• {"criterion_text":"-\tTotal thyroidectomy performed within 6 to 14 weeks before randomization"}
• {"criterion_text":"-\tPatient with or without anti-thyroglobulin antibodies (TgAb)"}
• {"criterion_text":"-\tNo known distant metastases"}
• {"criterion_text":"-\tNormal post-operative neck ultrasound (US) or if doubtful US, negative cytology and normal Tg value (<10 ng/ml) in FNA washout fluid"}
• {"criterion_text":"-\tPost-operative LT4 treatment initiated at least 6 weeks before randomization"}
• {"criterion_text":"-\tPerformance Status 0 or 1"}
• {"criterion_text":"-\tPatients aged 18 years or older"}

Exclusion criteria

• {"criterion_text":"-\tPatients with: o\tmedullary or anaplastic thyroid cancer o\tor poorly differentiated carcinoma o\tor well differentiated FTC with at least 4 foci of vascular invasion o\tor PTC with aggressive variants (tall cell or columnar cell carcinoma, diffuse sclerosing papillary, hobnail variant) o\tNIFTP (Noninvasive follicular thyroid neoplasm with papillary-like nuclear features)"}
• {"criterion_text":"-\tHistory 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"}
• {"criterion_text":"-\tLow-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: o\tAll pT3 or pT4 o\tpT1aN0/x with or without minimal extra-thyroid extension o\tpT1bN0/x, pT2N0/Nx without minimal extra-thyroid extension o\tpT1aN1 or pT1bN1 or pT2N1 without extra-thyroid extension and with nodal largest dimension <2mm o\tpT1aN1 or pT1bN1 or pT2N1 without extra-thyroid extension and with nodal largest dimension >10mm o\tSurgery considered as macroscopically incomplete (R2)"}
• {"criterion_text":"-\tPatients who have undergone lobectomy only"}
• {"criterion_text":"-\tPost-operative neck US with metastatic lymph-nodes confirmed by cytology or by increased Tg (>10 ng/ml) in FNA washout fluid"}
• {"criterion_text":"-\tDrugs 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."}
• {"criterion_text":"-\tPrevious RAI treatment for thyroid cancer"}
• {"criterion_text":"-\tPregnant or lactating women"}
• {"criterion_text":"-\tAny associated geographical, social or psychopathological condition that could compromise the patient's ability to participate in the study"}
• {"criterion_text":"-\tPatient deprived of liberty or placed under the authority of a tutor"}

Primary endpoints

• {"endpoint_text":"-\tThe primary endpoint is the rate of patients with excellent response (normal neck ultrasonography and Tg/LT4 <0.2 ng/mL and absence of TgAb and if performed, no abnormalities on other imaging modalities), at 3 years post-randomization","definition_or_measurement_approach":"Excellent response defined as normal neck ultrasonography and Tg/LT4 <0.2 ng/mL and absence of TgAb and, if performed, no abnormalities on other imaging modalities; measured as the rate of patients meeting this definition at 3 years post-randomization (ATA 2015 criteria)."}

Secondary endpoints

• {"endpoint_text":"-\tExcellent response rate at 1 and 5 years post-randomization, defined as above, will be used for non-inferiority comparison","definition_or_measurement_approach":"Excellent response defined as for the primary endpoint; measured as rate at 1 and 5 years post-randomization."}
• {"endpoint_text":"-\tThe scores on HRQoL, anxiety and fear of cancer recurrence will be calculated according to the corresponding scoring manual from the various questionnaires at inclusion, end of diagnostic assessment, end of treatment (for treated patients), 1 year and 3 years. The lachrymal, nasal and salivary glands toxicities will be evaluated from specific questionnaires at inclusion, end of diagnostic assessment, end of treatment (for treated patients), 1 year and 3 years","definition_or_measurement_approach":"HRQoL, anxiety and fear of recurrence scored per respective validated questionnaires (e.g. SF-36, STAI, IES) at specified timepoints; gland toxicities evaluated using specific questionnaires at same timepoints."}
• {"endpoint_text":"-\tSupplemental treatments (surgery, RAI administration or others) performed within 5 years post-randomization in both groups. The response to these treatments will be defined according to the 2015 ATA guidelines: excellent response, biochemical incomplete response, structural incomplete response, and indeterminate response","definition_or_measurement_approach":"Record supplemental treatments within 5 years and classify responses per 2015 ATA guidelines into excellent, biochemical incomplete, structural incomplete, indeterminate."}
• {"endpoint_text":"-\tCosts within 5 years post-randomization in both groups, from the French collective perspective, taking into account the resources such as: \tExternal consultations, hospitalizations \tImaging exams (neck-US, scintigraphy, CT scans…) \tBiological exams \tTransportation related to the care \tStudy treatments: I131 and rhTSH \tTreatment for possible recurrence (surgery, RAI administration or others) \tSick leave related to thyroid cancer","definition_or_measurement_approach":"Health economic analysis from French collective perspective over 5 years including listed resource categories; cost calculation methods not further specified in the CTIS JSON."}
• {"endpoint_text":"-\tThe results of diagnostic and post-therapeutic scintigraphy (in the guided follow-up group)","definition_or_measurement_approach":"Outcomes of diagnostic and post-therapeutic RAI scintigraphy recorded for the guided follow-up group; specific image interpretation criteria not provided here."}
• {"endpoint_text":"-\tThe proportion of patients for whom the results of the diagnostic RAI scintigraphy have changed the decision-making for RAI treatment (in the guided follow-up group)","definition_or_measurement_approach":"Proportion of patients in guided group whose management decision (to give RAI or not) was changed as a result of diagnostic RAI scintigraphy."}
• {"endpoint_text":"-\tThe post-operative serum Tg levels on Levothyroxine treatment (Tg/LT4) and after rhTSH (Tg/rhTSH) to assess their predictive value on the presence of RAI-avid lesions in the RAI group and on the rate of excellent response at 3 years in both groups","definition_or_measurement_approach":"Measure Tg/LT4 and Tg after rhTSH and assess predictive performance for presence of RAI-avid lesions (post-therapeutic scintigraphy) and for excellent response at 3 years."}
• {"endpoint_text":"-\tThe excellent response rate at 3 and 5 years after randomization in case of supplemental treatments","definition_or_measurement_approach":"Rate of excellent response at 3 and 5 years among patients who received supplemental treatments; defined as per ATA 2015."}
• {"endpoint_text":"-\tThe predictive values of somatic molecular markers (especially BRAF and TERTp) on the risk of persistent disease","definition_or_measurement_approach":"Assess predictive value of collected somatic markers (e.g. BRAF, TERTp) on risk of persistent disease; based on tumor biobank molecular analysis."}

France

Earliest CTIS Part Ii Submission Date

04-06-2024

Latest Decision Or Authorization Date

08-10-2025

Processing Time Days

491

Number Of Sites

29

Number Of Participants

476

Primary sponsor

Full Name

Centre Francois Baclesse

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"INCa (PHRC-K)","duties_or_roles":"Source of monetary support","organisation_type":""}