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Recruiting NCT04290663

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

Phase III Interventional Thyroid Cancer Intermediate Risk

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Systematic RAI-treatment, Decision of RAI-treatment guided by a post-operative assessment.
Who it may be relevant to
Registry conditions: Thyroid Cancer, Intermediate Risk. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Multicentric Phase III Trial 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

Overview

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

Interventions

  • Drug Systematic RAI-treatment
    Administration of 3.7 GBq (100 mCi) or 1,1 GBq (30 mCi) of I131 at the choice of the investigator after rhTSH-stimulation
  • Other Decision of RAI-treatment guided by a post-operative assessment
    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 metastasi

Primary outcome measures

  • the rate of patients with excellent tumoral response [Time frame: 36 months after randomization]
Secondary outcome measures (4)
  • Patient's quality-of-life [Time frame: During I131 treatment and at 1 and 3 years]
  • Salivary, nasal and lachrymal toxicities [Time frame: During I131 treatment and at 1,2,3 and 5 years]
  • Management cost [Time frame: through study completion, an average of 5 years]
  • Patient's anxiety [Time frame: During I131 treatment and at 1 and 3 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

France · 29 centers
  • CHU Pointe à pitre — Pointe à Pitre
  • Chu Angers — Angers
  • Institu de Cancérologie de l'Ouest - Site Angers — Angers
  • Bergonié — Bordeaux
  • Hôpital saint-André — Bordeaux
  • Chu Brest — Brest
  • Centre Francois Baclesse — Caen
  • Centre Hospitalier Métropôle Savoie — Chambéry
  • … and 21 more centers

Identifiers

NCT: NCT04290663 · 2019-002968-27

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗