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

ConditionsThyroid CancerIntermediate Risk
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Francois Baclesse

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Systematic RAI-treatment

    Drug

    Administration of 3.7 GBq (100 mCi) or 1,1 GBq (30 mCi) of I131 at the choice of the investigator after rhTSH-stimulation

  • Decision of RAI-treatment guided by a post-operative assessment

    Other intervention

    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

Treatment groups

368 Participants
are divided into 2 treatment groups
Group A: RAI groupActive comparator 1 intervention
Group B: GUIDED FOLLOW-UP groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Francois Baclesse

Lead sponsor

French cancer Institute INCa

Collaborator

Source ClinicalTrials.gov
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