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

Who is this study for? Adult patients with thyroid cancer
What treatments are being studied? Decision of RAI-treatment guided by a post-operative assessment
Status: Recruiting
Location: See all (29) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Chu Angers
RECRUITING
Angers
Institu de Cancérologie de l'Ouest - Site Angers
RECRUITING
Angers
Bergonié
RECRUITING
Bordeaux
Hôpital saint-André
RECRUITING
Bordeaux
Chu Brest
RECRUITING
Brest
Centre Francois Baclesse
RECRUITING
Caen
Centre Hospitalier Métropôle Savoie
RECRUITING
Chambéry
Centre Jean Perrin
RECRUITING
Clermont-ferrand
Centre Georges-François Leclerc
RECRUITING
Dijon
Chu Martinique
RECRUITING
Fort De France
Chu Grenoble
RECRUITING
Grenoble
Chru Lille
RECRUITING
Lille
Centre Léon Bérard
RECRUITING
Lyon
Hospices Civils de Lyon
RECRUITING
Lyon
CHU Timone
RECRUITING
Marseille
Chu Nancy
RECRUITING
Nancy
Chu Nantes
RECRUITING
Nantes
Centre Antoine Lacassagne -
RECRUITING
Nice
Chu Nimes
RECRUITING
Nîmes
AP-HP Pitié Salpétrière
RECRUITING
Paris
CHU Pointe à pitre
NOT_YET_RECRUITING
Pointe À Pitre
Centre Jean Godinot
RECRUITING
Reims
Centre Henri Becquerel
RECRUITING
Rouen
Institut CURIE, site Réné Huguenin
RECRUITING
Saint-cloud
Institu de Cancérologie de l'Ouest - Site St Herblain
RECRUITING
Saint-herblain
Centre Paul Strauss
RECRUITING
Strasbourg
CHU TOULOUSE, Hôpital Larrey
RECRUITING
Toulouse
IUCT Oncopole
RECRUITING
Toulouse
Institut Gustave Roussy
RECRUITING
Villejuif
Contact Information
Primary
Stéphane BARDET, MD
s.bardet@baclesse.unicancer.fr
(33)231455050
Time Frame
Start Date: 2020-03-02
Estimated Completion Date: 2033-02
Participants
Target number of participants: 476
Treatments
Active_comparator: RAI group
Experimental: GUIDED FOLLOW-UP group
Related Therapeutic Areas
Sponsors
Collaborators: French cancer Institute INCa
Leads: Centre Francois Baclesse

This content was sourced from clinicaltrials.gov