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Systematic Radioiodine Administration (3.7 GBq I131 After rhTSH) Versus Decision of Radioiodine Treatment Guided by a Post-operative Work-up (INTERMEDIATE)

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ClinicalTrials.gov Identifier: NCT04290663
Recruitment Status : Recruiting
First Posted : March 2, 2020
Last Update Posted : April 15, 2020
Sponsor:
Collaborator:
French cancer Institute INCa
Information provided by (Responsible Party):
Centre Francois Baclesse

Brief Summary:
This trial is comparing two strategies in intermediate-risk differentiated thyroid cancer patients: Systematic radioiodine administration (3.7 GBq I131 after rhTSH) versus decision of radioiodine treatment guided by a post-operative work-up based on serum Tg values and diagnostic RAI scintigraphy

Condition or disease Intervention/treatment Phase
Thyroid Cancer Intermediate Risk Drug: Systematic RAI-treatment Other: Decision of RAI-treatment guided by a post-operative assessment Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 476 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicentric Phase III Trial Comparing Two Strategies in Intermediate-risk Differentiated Thyroid Cancer Patients: Systematic Radioiodine Administration (3.7 GBq I131 After rhTSH) Versus Decision of Radioiodine Treatment Guided by a Post-operative Work-up Based on Serum Tg Values and Diagnostic RAI Scintigraphy
Actual Study Start Date : March 2, 2020
Estimated Primary Completion Date : February 2026
Estimated Study Completion Date : February 2028

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: RAI group Drug: Systematic RAI-treatment
Administration of 3.7 GBq (100 mCi) of I131 after rhTSH-stimulation

Experimental: GUIDED FOLLOW-UP group 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




Primary Outcome Measures :
  1. the rate of patients with excellent tumoral response [ Time Frame: 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 :
  1. Patient's quality-of-life [ Time Frame: During I131 treatment and at 1 and 3 years ]
    Comparison of the scores on SF-36 (score between 0 and 100) between 2 arms

  2. Salivary, nasal and lachrymal toxicities [ Time Frame: During I131 treatment and at 1,2,3 and 5 years ]
    Comparison of the intensity of salivary, nasal and lachrymal toxicities between 2 arms

  3. Management cost [ Time Frame: 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

  4. Patient's anxiety [ Time Frame: During I131 treatment and at 1 and 3 years ]
    Comparison of the scores on STAI questionnaire (score between 20 and 80) between 2 arms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ≤ 5
    • T1aN1 with largest nodal dimension between 2 and 10 mm, without extra-capsular invasion and with a number of metastatic nodes ≤ 5
  • 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 5 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04290663


Contacts
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Contact: Stéphane BARDET, MD (33)231455050 s.bardet@baclesse.unicancer.fr

Locations
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France
Centre Francois Baclesse Recruiting
Caen, France
Contact: Stéphane BARDET, MD         
Sponsors and Collaborators
Centre Francois Baclesse
French cancer Institute INCa
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Responsible Party: Centre Francois Baclesse
ClinicalTrials.gov Identifier: NCT04290663    
Other Study ID Numbers: 2019-002968-27
First Posted: March 2, 2020    Key Record Dates
Last Update Posted: April 15, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Francois Baclesse:
radioiodine
I131
Additional relevant MeSH terms:
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Thyroid Neoplasms
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms