Actively Recruiting
Systematic Radioiodine Administration Versus Decision of Radioiodine Treatment Guided by a Post-operative Work-up
Led by Centre Francois Baclesse · Updated on 2025-10-14
476
Participants Needed
29
Research Sites
674 weeks
Total Duration
On this page
Sponsors
C
Centre Francois Baclesse
Lead Sponsor
F
French cancer Institute INCa
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Systematic Radioiodine Administration Versus Decision of Radioiodine Treatment Guided by a Post-operative Work-up
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with intermediate-risk differentiated thyroid cancer defined by TNM 2017 criteria, including specific tumor and lymph node characteristics
- Papillary thyroid cancer without aggressive subtype, follicular thyroid cancer with fewer than 4 vascular invasion foci, or Hürthle cell carcinoma
- Total thyroidectomy with macroscopically complete tumor removal (R0 or R1) with or without neck dissection
- Surgery performed within 6 to 14 weeks before randomization
- Presence or absence of anti-thyroglobulin antibodies
- No known distant metastases
- Normal post-operative neck ultrasound or negative cytology and normal Tg value (<10 ng/ml) in fine needle aspiration washout fluid if ultrasound is doubtful
- Post-operative levothyroxine (LT4) treatment started at least 6 weeks before randomization
- Performance status score of 0 or 1
- Age 18 years or older
- Signed informed consent
- Willingness to be followed annually for 5 years
- Affiliated with French social security system
You will not qualify if you...
- Diagnosis of medullary or anaplastic thyroid cancer
- Poorly differentiated carcinoma
- Well differentiated follicular thyroid cancer with more than 4 vascular invasion foci
- Papillary thyroid cancer with aggressive variants (tall cell, columnar cell, diffuse sclerosing, hobnail)
- Noninvasive follicular thyroid neoplasm with papillary-like nuclear features (NIFTP)
- Low-risk or high-risk differentiated thyroid cancer patients as per ATA 2015, or intermediate-risk patients with extensive extra-thyroid extension or extensive lymph node involvement
- Surgery considered macroscopically incomplete (R2)
- Patients who had lobectomy only
- Post-operative neck ultrasound showing metastatic lymph nodes confirmed by cytology or elevated Tg (>10 ng/ml) in washout fluid
- Use of drugs affecting thyroid function including iodinated contrast agents within 6 weeks prior to randomization; amiodarone stopped less than 1 year before randomization
- Previous radioiodine treatment for thyroid cancer
- Pregnant or breastfeeding women
- Conditions compromising ability to participate including certain social or psychological issues
- Patients deprived of liberty or under legal guardianship
- History of malignancy in past 3 years except certain skin cancers and treated tumors without recurrence
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 29 locations
1
CHU Pointe à pitre
Pointe à Pitre, Guadeloupe, France
Not Yet Recruiting
2
Chu Angers
Angers, France
Actively Recruiting
3
Institu de Cancérologie de l'Ouest - Site Angers
Angers, France
Actively Recruiting
4
Bergonié
Bordeaux, France
Actively Recruiting
5
Hôpital saint-André
Bordeaux, France
Actively Recruiting
6
Chu Brest
Brest, France
Actively Recruiting
7
Centre Francois Baclesse
Caen, France
Actively Recruiting
8
Centre Hospitalier Métropôle Savoie
Chambéry, France
Actively Recruiting
9
Centre Jean Perrin
Clermont-Ferrand, France
Actively Recruiting
10
Centre Georges-François Leclerc
Dijon, France
Actively Recruiting
11
Chu Martinique
Fort de France, France
Actively Recruiting
12
Chu Grenoble
Grenoble, France
Actively Recruiting
13
Chru Lille
Lille, France
Actively Recruiting
14
Centre Léon Bérard
Lyon, France
Actively Recruiting
15
Hospices Civils de Lyon
Lyon, France
Actively Recruiting
16
CHU Timone
Marseille, France
Actively Recruiting
17
Chu Nancy
Nancy, France
Actively Recruiting
18
Chu Nantes
Nantes, France
Actively Recruiting
19
Centre Antoine Lacassagne -
Nice, France
Actively Recruiting
20
Chu Nimes
Nîmes, France
Actively Recruiting
21
AP-HP Pitié Salpétrière
Paris, France
Actively Recruiting
22
Centre Jean Godinot
Reims, France
Actively Recruiting
23
Centre Henri Becquerel
Rouen, France
Actively Recruiting
24
Institut CURIE, site Réné Huguenin
Saint-Cloud, France
Actively Recruiting
25
Institu de Cancérologie de l'Ouest - Site St Herblain
Saint-Herblain, France
Actively Recruiting
26
Centre Paul Strauss
Strasbourg, France
Actively Recruiting
27
CHU TOULOUSE, Hôpital Larrey
Toulouse, France
Actively Recruiting
28
IUCT Oncopole
Toulouse, France
Actively Recruiting
29
Institut Gustave Roussy
Villejuif, France
Actively Recruiting
Research Team
S
Stéphane BARDET, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here