Clinical trial NCT04290663: Systematic Radioiodine Administration Versus Decision of Radioiodine Treatment Guided by a Post-operative Work-up
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Thyroid Cancer
Intermediate Risk
Keywords: radioiodine
I131
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
Collaborators: name: French cancer Institute INCa
First posted: 2020-03-02
Enrollment: 476
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Primary outcomes:
measure: the rate of patients with excellent tumoral response
timeFrame: 36 months after randomization
Secondary outcomes:
measure: Patient's quality-of-life
timeFrame: During I131 treatment and at 1 and 3 years
measure: Salivary, nasal and lachrymal toxicities
timeFrame: During I131 treatment and at 1,2,3 and 5 years
measure: Management cost
timeFrame: through study completion, an average of 5 years
measure: Patient's anxiety
timeFrame: During I131 treatment and at 1 and 3 years
Other outcomes:
Locations:
city: Pointe À Pitre
country: France
facility: CHU Pointe à pitre
state: Guadeloupe
city: Angers
country: France
facility: Chu Angers
city: Angers
country: France
facility: Institu de Cancérologie de l'Ouest - Site Angers
city: Bordeaux
country: France
facility: Bergonié
city: Bordeaux
country: France
facility: Hôpital saint-André
city: Brest
country: France
facility: Chu Brest
city: Caen
country: France
facility: Centre Francois Baclesse
city: Chambéry
country: France
facility: Centre Hospitalier Métropôle Savoie
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Dijon
country: France
facility: Centre Georges-François Leclerc
city: Fort De France
country: France
facility: Chu Martinique
city: Grenoble
country: France
facility: Chu Grenoble
city: Lille
country: France
facility: Chru Lille
city: Lyon
country: France
facility: Centre Léon Bérard
city: Lyon
country: France
facility: Chu Lyon,
city: Marseille
country: France
facility: CHU Timone
city: Nancy
country: France
facility: Chu Nancy
city: Nantes
country: France
facility: Chu Nantes
city: Nice
country: France
facility: Centre Antoine Lacassagne -
city: Nîmes
country: France
facility: Chu Nimes
city: Paris
country: France
facility: AP-HP Pitié Salpétrière
city: Reims
country: France
facility: Centre Jean Godinot
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Saint-Cloud
country: France
facility: Institut CURIE, site Réné Huguenin
city: Saint-Herblain
country: France
facility: Institu de Cancérologie de l'Ouest - Site St Herblain
city: Strasbourg
country: France
facility: Centre Paul Strauss
city: Toulouse
country: France
facility: CHU TOULOUSE, Hôpital Larrey
city: Toulouse
country: France
facility: IUCT Oncopole
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
References: