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

Phase 3

Recruiting

• Conditions: Thyroid Cancer; Intermediate Risk
• Interventions: Drug: Systematic RAI-treatment; Other: Decision of RAI-treatment guided by a post-operative assessment

• Registration Number: NCT04290663
• Lead Sponsor: Centre Francois Baclesse

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-20
• Study First Submitted QC: 2020-02-28
• Study Start: 2020-03-02
• Study First Posted: 2020-03-02
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-17
• Last Update Posted: 2025-01-20
• Primary Completion: 2031-02
• Study Completion: 2033-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 476

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RAI group	Systematic RAI-treatment	-
GUIDED FOLLOW-UP group	Decision of RAI-treatment guided by a post-operative assessment	-

Primary Outcome Measures

Name	Time	Method
the rate of patients with excellent tumoral response	36 months after randomization	normal neck ultrasonography and Tg/LT4 \<0.2 ng/mL and absence of TgAb and if performed, no abnormalities on other imaging modalities

Secondary Outcome Measures

Name	Time	Method
Management cost	through study completion, an average of 5 years	Costs of all medical exams and transportation related to the care within 5 years post-randomization in both groups
Patient's anxiety	During I131 treatment and at 1 and 3 years	Comparison of the scores on STAI questionnaire (score between 20 and 80) between 2 arms
Salivary, nasal and lachrymal toxicities	During I131 treatment and at 1,2,3 and 5 years	Comparison of the intensity of salivary, nasal and lachrymal toxicities between 2 arms
Patient's quality-of-life	During I131 treatment and at 1 and 3 years	Comparison of the scores on SF-36 (score between 0 and 100) between 2 arms

Trial Locations

Locations (29)

Chu Martinique; 🇫🇷 Fort De France, France

CHU Pointe à pitre; 🇫🇷 Pointe À Pitre, Guadeloupe, France

Chu Angers; 🇫🇷 Angers, France

Institu de Cancérologie de l'Ouest - Site Angers; 🇫🇷 Angers, France

Bergonié; 🇫🇷 Bordeaux, France

Hôpital saint-André; 🇫🇷 Bordeaux, France

Chu Brest; 🇫🇷 Brest, France

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France

Centre Francois Baclesse; 🇫🇷 Caen, France

Centre Hospitalier Métropôle Savoie; 🇫🇷 Chambéry, France

Centre Georges-François Leclerc; 🇫🇷 Dijon, France

Chu Grenoble; 🇫🇷 Grenoble, France

Chru Lille; 🇫🇷 Lille, France

Centre Léon Bérard; 🇫🇷 Lyon, France

Chu Lyon,; 🇫🇷 Lyon, France

CHU Timone; 🇫🇷 Marseille, France

Chu Nancy; 🇫🇷 Nancy, France

Chu Nantes; 🇫🇷 Nantes, France

Centre Antoine Lacassagne -; 🇫🇷 Nice, France

Chu Nimes; 🇫🇷 Nîmes, France

AP-HP Pitié Salpétrière; 🇫🇷 Paris, France

Centre Jean Godinot; 🇫🇷 Reims, France

Centre Henri Becquerel; 🇫🇷 Rouen, France

Institut CURIE, site Réné Huguenin; 🇫🇷 Saint-Cloud, France

Institu de Cancérologie de l'Ouest - Site St Herblain; 🇫🇷 Saint-Herblain, France

Centre Paul Strauss; 🇫🇷 Strasbourg, France

CHU TOULOUSE, Hôpital Larrey; 🇫🇷 Toulouse, France

IUCT Oncopole; 🇫🇷 Toulouse, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France