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

NCT04290663 | Recruiting Phase 3

• 1 other identifier: 2019-002968-27
• Study Type: interventional
• Target: 476
• Locations: 1 country
• Sites: 29

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

Conditions

Thyroid Cancer; Intermediate Risk

Keywords

radioiodine; I131

Outcome Measures

Primary Outcomes (1)

• the rate of patients with excellent tumoral response

  normal neck ultrasonography and Tg/LT4 \<0.2 ng/mL and absence of TgAb and if performed, no abnormalities on other imaging modalities

  36 months after randomization

Secondary Outcomes (4)

• Patient's quality-of-life

  During I131 treatment and at 1 and 3 years

• Salivary, nasal and lachrymal toxicities

  During I131 treatment and at 1,2,3 and 5 years

• Management cost

  through study completion, an average of 5 years

• Patient's anxiety

  During I131 treatment and at 1 and 3 years

Study Arms (2)

RAI group

ACTIVE COMPARATOR

Drug: Systematic RAI-treatment

GUIDED FOLLOW-UP group

EXPERIMENTAL

Other: Decision of RAI-treatment guided by a post-operative assessment

Interventions

Systematic RAI-treatment DRUG

Administration of 3.7 GBq (100 mCi) or 1,1 GBq (30 mCi) of I131 at the choice of the investigator after rhTSH-stimulation

RAI group

Decision of RAI-treatment guided by a post-operative assessment OTHER

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 metastasis detected on diagnostic RAI-scintigraphy or on the hybrid CT scan of the SPECT-CT acquisition

GUIDED FOLLOW-UP group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify 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)
• 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

Sponsors & Collaborators

• Centre Francois Baclesse: lead
• French cancer Institute INCa: collaborator

Study Sites (29)

CHU Pointe à pitre

Pointe à Pitre, Guadeloupe, France

NOT YET RECRUITING

Chu Angers

Angers, France

RECRUITING

Institu de Cancérologie de l'Ouest - Site Angers

Angers, France

RECRUITING

Bergonié

Bordeaux, France

RECRUITING

Hôpital saint-André

Bordeaux, France

RECRUITING

Chu Brest

Brest, France

RECRUITING

Centre Francois Baclesse

Caen, France

RECRUITING

Centre Hospitalier Métropôle Savoie

Chambéry, France

RECRUITING

Centre Jean Perrin

Clermont-Ferrand, France

RECRUITING

Centre Georges-François Leclerc

Dijon, France

RECRUITING

Chu Martinique

Fort de France, France

RECRUITING

Chu Grenoble

Grenoble, France

RECRUITING

Chru Lille

Lille, France

RECRUITING

Centre Léon Bérard

Lyon, France

RECRUITING

Hospices Civils de Lyon

Lyon, France

RECRUITING

CHU Timone

Marseille, France

RECRUITING

Chu Nancy

Nancy, France

RECRUITING

Chu Nantes

Nantes, France

RECRUITING

Centre Antoine Lacassagne -

Nice, France

RECRUITING

Chu Nimes

Nîmes, France

RECRUITING

AP-HP Pitié Salpétrière

Paris, France

RECRUITING

Centre Jean Godinot

Reims, France

RECRUITING

Centre Henri Becquerel

Rouen, France

RECRUITING

Institut CURIE, site Réné Huguenin

Saint-Cloud, France

RECRUITING

Institu de Cancérologie de l'Ouest - Site St Herblain

Saint-Herblain, France

RECRUITING

Centre Paul Strauss

Strasbourg, France

RECRUITING

CHU TOULOUSE, Hôpital Larrey

Toulouse, France

RECRUITING

IUCT Oncopole

Toulouse, France

RECRUITING

Institut Gustave Roussy

Villejuif, France

RECRUITING

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Central Study Contacts

Stéphane BARDET, MD

CONTACT

(33)231455050; s.bardet@baclesse.unicancer.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: March 2, 2020
• Study Start: March 2, 2020
• Primary Completion (Estimated): February 1, 2031
• Study Completion (Estimated): February 1, 2033
• Last Updated: October 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (29)