NCT04290663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 Baclesse55 个研究点 分布在 1 个国家目标入组 368 人开始时间: 2020年3月2日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 368
- 试验地点
- 55
- 主要终点
- the rate of patients with excellent tumoral response
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 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:
- •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
排除标准
- •• 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
研究组 & 干预措施
RAI group
Active Comparator
干预措施: Systematic RAI-treatment (Drug)
GUIDED FOLLOW-UP group
Experimental
干预措施: Decision of RAI-treatment guided by a post-operative assessment (Other)
结局指标
主要结局
the rate of patients with excellent tumoral response
时间窗: 36 months after randomization
normal neck ultrasonography and Tg/LT4 \<0.2 ng/mL and absence of TgAb and if performed, no abnormalities on other imaging modalities
次要结局
- Management cost(through study completion, an average of 5 years)
- Patient's anxiety(During I131 treatment and at 1 and 3 years)
- Salivary, nasal and lachrymal toxicities(During I131 treatment and at 1,2,3 and 5 years)
- Patient's quality-of-life(During I131 treatment and at 1 and 3 years)
研究者
研究点 (55)
Loading locations...
相似试验
已完成
3 期
Comparing Two Different Myeloablation Therapies in Treating Young Patients Who Are Undergoing a Stem Cell Transplant for High-Risk NeuroblastomaLocalized Resectable NeuroblastomaLocalized Unresectable NeuroblastomaRecurrent NeuroblastomaRegional NeuroblastomaStage 4 NeuroblastomaStage 4S NeuroblastomaNCT00567567Children's Oncology Group665
已完成
3 期
Combination Chemotherapy Followed By Peripheral Stem Cell Transplant in Treating Young Patients With Newly Diagnosed Supratentorial Primitive Neuroectodermal Tumors or High-Risk MedulloblastomaAnaplastic MedulloblastomaSupratentorial Embryonal Tumor, Not Otherwise SpecifiedUntreated Childhood Supratentorial Primitive Neuroectodermal TumorMedulloblastomaNCT00336024Children's Oncology Group91
进行中（未招募）
1 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 scintigraphyintermediate-risk differentiated thyroid cancer patientsMedDRA version: 24.0Level: PTClassification code: 10033701Term: Papillary thyroid cancer Class: 100000004864MedDRA version: 21.1Level: PTClassification code: 10016935Term: Follicular thyroid cancer Class: 100000004864MedDRA version: 21.1Level: PTClassification code: 10066474Term: Thyroid cancer Class: 100000004864CTIS2024-514603-34-00Centre Francois Baclesse476
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 scintigraphyintermediate-risk differentiated thyroid cancer patients2024-514603-34-00Centre Francois Baclesse476
已完成
3 期
Trial Comparing a Strategy Based on Molecular Analysis to the Empiric Strategy in Patients With CUPNeoplasms, Unknown PrimaryNCT01540058Gustave Roussy, Cancer Campus, Grand Paris243