Systematic Radioiodine Administration (3.7 GBq I131 After rhTSH) Versus Decision of Radioiodine Treatment Guided by a Post-operative Work-up

STATUS

Recruiting
End date

Feb 29, 2028
participants needed

476
sponsor

Centre Francois Baclesse

Send

Updated on 19 February 2024

See if I qualify

cancer

metastasis

carcinoma

neck dissection

thyroidectomy

vascular invasion

differentiated thyroid cancer

thyroglobulin

papillary thyroid carcinoma

thyrotropin alpha

follicular thyroid carcinoma

rhtsh

rtsh

hurthle cell carcinoma

Summary

This trial is comparing two strategies in intermediate-risk differentiated thyroid cancer patients: Systematic radioiodine administration (3.7 GBq I131 after rhTSH) versus decision of radioiodine treatment guided by a post-operative work-up based on serum Tg values and diagnostic RAI scintigraphy

Details

Condition	Thyroid Adenoma, head and neck cancer, head and neck cancer, Thyroid disorder, Intermediate Risk
Age	18-100 years
Treatment	Systematic RAI-treatment, Decision of RAI-treatment guided by a post-operative assessment
Clinical Study Identifier	NCT04290663
Sponsor	Centre Francois Baclesse
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	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 Hrthle 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 5
	T1aN1 with largest nodal dimension between 2 and 10 mm, without extra-capsular invasion and with a number of metastatic nodes 5
	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
Exclusion Criteria
	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 5 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

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Systematic Radioiodine Administration (3.7 GBq I131 After rhTSH) Versus Decision of Radioiodine Treatment Guided by a Post-operative Work-up