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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
476
Administration of 3.7 GBq (100 mCi) or 1,1 GBq (30 mCi) of I131 at the choice of the investigator after rhTSH-stimulation
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 metastasis detected on diagnostic RAI-scintigraphy or on the hybrid CT scan of the SPECT-CT acquisition
CHU Pointe à pitre
Pointe à Pitre, Guadeloupe, France
the rate of patients with excellent tumoral response
normal neck ultrasonography and Tg/LT4 \<0.2 ng/mL and absence of TgAb and if performed, no abnormalities on other imaging modalities
Time frame: 36 months after randomization
Patient's quality-of-life
Comparison of the scores on SF-36 (score between 0 and 100) between 2 arms
Time frame: During I131 treatment and at 1 and 3 years
Salivary, nasal and lachrymal toxicities
Comparison of the intensity of salivary, nasal and lachrymal toxicities between 2 arms
Time frame: During I131 treatment and at 1,2,3 and 5 years
Management cost
Costs of all medical exams and transportation related to the care within 5 years post-randomization in both groups
Time frame: through study completion, an average of 5 years
Patient's anxiety
Comparison of the scores on STAI questionnaire (score between 20 and 80) between 2 arms
Time frame: During I131 treatment and at 1 and 3 years
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