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

Thyroid Cancer Clinical Trial

— INTERMEDIATE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04290663
• Other study ID #: 2019-002968-27
• Status: Recruiting
• Phase: Phase 3
• Start date: March 2, 2020
• Est. completion date: February 2033

Study information

• Verified date: May 2024
• Source: Centre Francois Baclesse
• Contact: Stéphane BARDET, MD
• Phone: (33)231455050
• Email: s.bardet[@]baclesse.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 476
• Est. completion date: February 2033
• Est. primary completion date: February 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intermediate Risk
• Thyroid Cancer
• Thyroid Neoplasms

Intervention

Drug:
• Systematic RAI-treatment
Administration of 3.7 GBq (100 mCi) or 1,1 GBq (30 mCi) of I131 at the choice of the investigator after rhTSH-stimulation

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

Locations

Country	Name	City	State
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 Francois Baclesse	Caen
France	Centre Hospitalier Métropôle Savoie	Chambéry
France	Centre Jean Perrin	Clermont-Ferrand
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	CHU Pointe à pitre	Pointe À Pitre	Guadeloupe
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

Sponsors (2)

Lead Sponsor	Collaborator
Centre Francois Baclesse	French cancer Institute INCa

Country where clinical trial is conducted

France, 

Outcome

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