Systematic Radioiodine Administration Versus Decision of Radioiodine Treatment Guided by a Post-operative Work-up
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
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
Treatments tested in this trial
- Systematic RAI-treatment
- Decision of RAI-treatment guided by a post-operative assessment
Treatment groups
368 Participants
are divided into 2 treatment groupsSponsors and collaborators
Centre Francois Baclesse
Lead sponsor
French cancer Institute INCa
Collaborator
Source ClinicalTrials.gov