Systematic Radioiodine Administration Versus Decision of Radioiodine Treatment Guided by a Post-operative Work-up

Официальное название

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

Обзор

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

Вмешательства

• Препарат Systematic RAI-treatment
  Administration of 3.7 GBq (100 mCi) or 1,1 GBq (30 mCi) of I131 at the choice of the investigator after rhTSH-stimulation
• Другое Decision of RAI-treatment guided by a post-operative assessment
  The decision-making for the administration of an adapted RAI-treatment will be taken according to the following criteria: * No RAI treatment if Tg/LT4 ≤1 ng/mL and rhTSH-sTg ≤10 ng/mL and normal diagnostic RAI-scintigraphy * 1.1 GBq after rhTSH if Tg/LT4\>1 ng/mL or rhTSH-sTg\>10 ng/mL and normal diagnostic RAI-scintigraphy. * 3.7 GBq after rhTSH if metastatic lymph-node(s) detected on diagnostic RAI-scintigraphy without distant metastasis * 3.7 GBq after hormone withdrawal if distant metastasi

Первичные конечные точки

• the rate of patients with excellent tumoral response [Срок оценки: 36 months after randomization]

Вторичные конечные точки (4)

• Patient's quality-of-life [Срок оценки: During I131 treatment and at 1 and 3 years]
• Salivary, nasal and lachrymal toxicities [Срок оценки: During I131 treatment and at 1,2,3 and 5 years]
• Management cost [Срок оценки: through study completion, an average of 5 years]
• Patient's anxiety [Срок оценки: During I131 treatment and at 1 and 3 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 29 центров

• CHU Pointe à pitre — Pointe à Pitre
• Chu Angers — Angers
• Institu de Cancérologie de l'Ouest - Site Angers — Angers
• Bergonié — Bordeaux
• Hôpital saint-André — Bordeaux
• Chu Brest — Brest
• Centre Francois Baclesse — Caen
• Centre Hospitalier Métropôle Savoie — Chambéry
• … и ещё 21 центр

Идентификаторы

NCT: NCT04290663 · 2019-002968-27

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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