2024-514603-34-00招募中3 期
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
Centre Francois Baclesse27 个研究点 分布在 1 个国家目标入组 476 人开始时间: 2024年6月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 476
- 试验地点
- 27
- 主要终点
- - The 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
研究概览
简要总结
- 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Guided Follow-up Group (experimental Arm)
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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) (with < 4 foci of vascular invasion) 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 a number of metastatic nodes ≤ 10 o T1aN1 with largest nodal dimension between 2 and 10 mm, without extra-capsular invasion and with a number of metastatic nodes ≤ 10
- •Signed informed consent form
- •Patient who agrees to be followed annually during 5 years
- •Patient affiliated to the French social security system
- •Patient treated by total thyroidectomy with macroscopically complete tumor resection (R0 or R1) ± neck dissection
- •Total thyroidectomy performed within 6 to 14 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
排除标准
- •Patients with: o medullary or anaplastic thyroid cancer o or poorly differentiated carcinoma o or well differentiated FTC with at least 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)
- •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
- •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: o All pT3 or pT4 o pT1aN0/x with or without minimal extra-thyroid extension o pT1bN0/x, pT2N0/Nx without minimal extra-thyroid extension o pT1aN1 or pT1bN1 or pT2N1 without extra-thyroid extension and with nodal largest dimension <2mm o pT1aN1 or pT1bN1 or pT2N1 without extra-thyroid extension and with nodal largest dimension >10mm o 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
结局指标
主要结局
- The 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
- The 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
次要结局
- - Excellent response rate at 1 and 5 years post-randomization, defined as above, 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) 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
- - Costs within 5 years post-randomization in both groups, from the French collective perspective, taking into account the resources such as: External consultations, hospitalizations Imaging exams (neck-US, scintigraphy, CT scans…) Biological exams Transportation related to the care Study treatments: I131 and rhTSH Treatment for possible recurrence (surgery, RAI administration or others) Sick leave related to thyroid cancer
- - The results of diagnostic and post-therapeutic scintigraphy (in the guided follow-up group)
- - The 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)
- - The 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
- - 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
研究者
Stéphane BARDET
Scientific
Centre Francois Baclesse
研究点 (27)
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