NCT04290663 Systematic Radioiodine Administration Versus Decision of Radioiodine Treatment Guided by a Post-operative Work-up
| NCT ID | NCT04290663 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Centre Francois Baclesse |
| Condition | Thyroid Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 368 participants |
| Start Date | 2020-03-02 |
| Primary Completion | 2031-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 368 participants in total. It began in 2020-03-02 with a primary completion date of 2031-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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 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 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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04290663 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Thyroid Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04290663 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 368 participants.
Is NCT04290663 currently recruiting?
Yes, NCT04290663 is actively recruiting participants. Contact the research team at r.ciappuccini@baclesse.unicancer.fr for enrollment information.
Where is the NCT04290663 trial being conducted?
This trial is being conducted at Pointe à Pitre, France, Angers, France, Angers, France, Bordeaux, France and 11 additional locations.
Who is sponsoring the NCT04290663 clinical trial?
NCT04290663 is sponsored by Centre Francois Baclesse. The trial plans to enroll 368 participants.
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