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Compares treatment options for Thyroid Cancer
Official title Systematic Radioiodine Administration Versus Decision of Radioiodine Treatment Guided by a Post-operative Work-up
ClinicalTrials.gov ID: NCT04290663
What this study is testing
What is Systematic RAI-treatment?
Systematic RAI-treatment is an investigational medicine, being studied as a potential treatment for thyroid cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- 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
You likely can't join if
- 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)
See the full eligibility 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
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Pointe à Pitre, Guadeloupe, France
- Angers, France
- Bordeaux, France
- Brest, France
- Caen, France
- Chambéry, France
- Clermont-Ferrand, France
- Dijon, France
- Fort de France, France
- Grenoble, France
- Lille, France
- Lyon, France
- Marseille, France
- Nancy, France
- Nantes, France
- Nice, France
- Nîmes, France
- Paris, France
- Reims, France
- Rouen, France
+ 5 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pointe à Pitre, Guadeloupe, France; Angers, France; Bordeaux, France; Brest, France; Caen, France; Chambéry, France and 19 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.