Differentiated thyroid cancer - subgroup of patients with intermediate risk of postoperative residual disease MedDRA version: 21.1 Level: PT Classification code 10066474 Term: Thyroid cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Pharmaceutical Form: Capsule
INN or Proposed INN: SODIUM IODIDE (131I)
Other descriptive name: SODIUM IODIDE (131I) CAPSULES FOR THERAPEUTIC USE
Concentration unit: GBq gigabecquerel(s)
Concentration
Sponsors
Centre François Baclesse
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subgroup of patients with differentiated thyroid cancer and intermediate-risk defined as follows according to TNM 2017: o Papillary thyroid cancer (PTC) without aggressive subtype, follicular thyroid cancer (FTC) or Hürthle cell carcinoma (HCC) o 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 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 (=65 years) yes F.1.3.1 Number of subjects for this age range 476
Exclusion criteria
Exclusion criteria: • Patients with: o medullary or anaplastic thyroid cancer o or poorly differentiated carcinoma o or well differentiated FTC with more than 4 foci of vascular invasion o or PTC with aggressive variants (tall cell or columnar cell carcinoma,diffuse sclerosing papillary, hobnail variant) o 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 5 positive nodes. This excludes the following patients: o All pT1a, pT3 or pT4 o pT1bN0/x without extra-thyroid extension o pT1bN1 without extra-thyroid extension and with nodal largest dimension 10mm o pT2N0/Nx without extra-thyroid extension o pT2N1 without extra-thyroid extension and with nodal largest dimension 10mm o Surgery 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: -To assess whether a strategy of RAI-treatment guided by a post-operative work-up is non-inferior to a systematic RAI-treatment strategy in terms of excellent response rate at 3 years post-randomization in a “low-risk” subgroup of patients within the intermediate-risk category.;Secondary Objective: - To compare both strategies in terms of: •Rate of excellent response at 1 and 5 years •Patient’s quality-of-life, anxiety, impact of event scale and fear of cancer recurrence, • Salivary, nasal and lachrymal toxicities • Supplemental treatments (RAI, surgery, others) performed within 5 years •Management cost over 5 years. -To compare diagnostic and post-therapeutic scintigraphy (in the guide follow-up group) -To assess the added value of diagnostic RAI scintigraphy in decision-making for RAI treatment (in the guide follow-up group) -To assess the predictive value of post-operative serum Tg level under Thyroxine (Tg/LT4) and after rhTSH (Tg/rhTSH) on the presence of RAI avid lesions on the post-therapeutic scintigraphy in the RAI group, and on the excellent response rate at 3 years in both groups -To assess the excellent response rate of cure in case of supplemental treatments -To collect a tumor biobank for further translational research ;Primary end point(s): the rate of patients with excellent response (normal neck ultrasonography and Tg on LT4 <0.2 ng/mL and the absence of TgAb and if performed no abnormalities on other imaging), at 3 years post-randomization;Timepoint(s) of evaluation of this end point: at 3 years post-randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Excellent response rate at 1 and 5 years post-randomization, defined similarly as above detailed, will be used for non-inferiority comparison - The 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 - Supplemental treatments (surgery, RAI administration or others) realized within 5 years post-randomization in both groups. The response to these treatments will be defined according to 2015 ATA guidelines: excellent response, biochemical incomplete response, structural incomplete response, and indeterminate response - Costs within 5 years post randomization in both groups, from the French collective perspective - The results of diagnostic and post-therapeutic scintigraphy (in the guide follow-up group) - The proportion of patients for whom the diagnostic RAI scintigraphy results will have changed the decision-making for RAI treatment (in the guided follow-up group) - The post-operative serum thyroglobulin (Tg/LT4) level and after rhTSH to assess its 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. - The excellent response rate at 3 and 5 years after randomization in case of supplemental treatments - The predictive values of somatic molecular markers (especially BRAF and TERTp) on the risk of persistent disease ;Timepoint(s) of evaluation of this end point: at inclusion, end of diagnostic assessment, end of treatment (for treated patients), 1 year, 3 years and 5 years | — |
Countries
France
Contacts
Public ContactLECONTE Alexandra
Centre François Baclesse
Outcome results
None listed