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    Summary
    EudraCT Number:2019-002968-27
    Sponsor's Protocol Code Number:INTERMEDIATE-01
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-12-06
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2019-002968-27
    A.3Full title of the trial
    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
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    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
    A.3.2Name or abbreviated title of the trial where available
    INTERMEDIATE-01
    INTERMEDIATE-01
    A.4.1Sponsor's protocol code numberINTERMEDIATE-01
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCentre François Baclesse
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMinistère de la santé/INCa (PHRC-K)
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre François Baclesse
    B.5.2Functional name of contact pointLECONTE Alexandra
    B.5.3 Address:
    B.5.3.1Street Address3 Avenue du Général Harris
    B.5.3.2Town/ cityCAEN
    B.5.3.3Post code14076
    B.5.3.4CountryFrance
    B.5.4Telephone number332314550505384
    B.5.5Fax number33231455158
    B.5.6E-maila.leconte@baclesse.unicancer.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSODIUM IODIDE (131I)
    D.3.9.3Other descriptive nameSODIUM IODIDE (131I) CAPSULES FOR THERAPEUTIC USE
    D.3.9.4EV Substance CodeSUB127359
    D.3.10 Strength
    D.3.10.1Concentration unit GBq gigabecquerel(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0 to 3.7
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product Yes
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Differentiated thyroid cancer - subgroup of patients with intermediate risk of postoperative residual disease
    E.1.1.1Medical condition in easily understood language
    Differentiated thyroid cancer - subgroup of patients with intermediate risk of postoperative residual disease
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10066474
    E.1.2Term Thyroid cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To assess whether a strategy of RAI-treatment guided by a post-operative work-up is non-inferior to a systematic RAI-treatment strategy in terms of excellent response rate at 3 years post-randomization in a “low-risk” subgroup of patients within the intermediate-risk category.
    E.2.2Secondary objectives of the trial
    - To compare both strategies in terms of:
    •Rate of excellent response at 1 and 5 years
    •Patient’s quality-of-life, anxiety, impact of event scale and fear of cancer recurrence,
    • Salivary, nasal and lachrymal toxicities
    • Supplemental treatments (RAI, surgery, others) performed within 5 years
    •Management cost over 5 years.
    -To compare diagnostic and post-therapeutic scintigraphy (in the guide follow-up group)
    -To assess the added value of diagnostic RAI scintigraphy in decision-making for RAI treatment (in the guide follow-up group)
    -To assess the predictive value of post-operative serum Tg level under Thyroxine (Tg/LT4) and after rhTSH (Tg/rhTSH) on the presence of RAI avid lesions on the post-therapeutic scintigraphy in the RAI group, and on the excellent response rate at 3 years in both groups
    -To assess the excellent response rate of cure in case of supplemental treatments
    -To collect a tumor biobank for further translational research
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Subgroup of patients with differentiated thyroid cancer and intermediate-risk defined as follows according to TNM 2017:
    o Papillary thyroid cancer (PTC) without aggressive subtype, follicular thyroid cancer (FTC) or Hürthle cell carcinoma (HCC)
    o 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 positive nodes ≤ 5
    • Patient treated by total thyroidectomy with complete tumor resection ± neck dissection
    • Total thyroidectomy performed within 6 to 10 weeks before randomization
    • Patient with or without anti-thyroglobulin antibodies (TgAb)
    • No known distant metastases
    • Normal post-operative neck 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 inclusion
    • PS 0 or 1
    • Patients aged 18 years or older
    • Signed informed consent form
    • Patient agreeing to be followed annually during 5 years
    • Patient affiliated to the social security system
    E.4Principal exclusion criteria
    • Patients with:
    o medullary or anaplastic thyroid cancer
    o or poorly differentiated carcinoma
    o or well differentiated FTC with more than 4 foci of vascular invasion
    o or PTC with aggressive variants (tall cell or columnar cell carcinoma,diffuse sclerosing papillary, hobnail variant)
    o 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 positive nodes. This excludes the following patients:
    o All pT1a, pT3 or pT4
    o pT1bN0/x without extra-thyroid extension
    o pT1bN1 without extra-thyroid extension and with nodal largest dimension <2mm
    o pT1bN1 without extra-thyroid extension and with nodal largest dimension >10mm
    o pT2N0/Nx without extra-thyroid extension
    o pT2N1 without extra-thyroid extension and with nodal largest dimension <2mm
    o pT2N1 without extra-thyroid extension and with nodal largest dimension >10mm
    o Surgery considered as incomplete
    • Patients who have undergone lobectomy only
    • Post-operative neck US with metastatic lymph-nodes proven cytologically or with increased Tg 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 show signs of recurrence for at least 3 years
    E.5 End points
    E.5.1Primary end point(s)
    the rate of patients with excellent response (normal neck ultrasonography and Tg on LT4 <0.2 ng/mL and the absence of TgAb and if performed no abnormalities on other imaging), at 3 years post-randomization
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 3 years post-randomization
    E.5.2Secondary end point(s)
    - Excellent response rate at 1 and 5 years post-randomization, defined similarly as above detailed, will be used for non-inferiority comparison
    - The scores on HRQoL, anxiety and fear of cancer recurrence will be calculated according to the corresponding scoring manual from the various questionnaires at inclusion, end of diagnostic assessment, end of treatment (for treated patients), 1 year and 3 years The lachrymal, nasal and salivary glands toxicities will be evaluated from specific questionnaires at inclusion, end of diagnostic assessment, end of treatment (for treated patients), 1 year and 3 years
    - Supplemental treatments (surgery, RAI administration or others) realized within 5 years post-randomization in both groups. The response to these treatments will be defined according to 2015 ATA guidelines: excellent response, biochemical incomplete response, structural incomplete response, and indeterminate response
    - Costs within 5 years post randomization in both groups, from the French collective perspective
    - The results of diagnostic and post-therapeutic scintigraphy (in the guide follow-up group)
    - The proportion of patients for whom the diagnostic RAI scintigraphy results will have changed the decision-making for RAI treatment (in the guided follow-up group)
    - The post-operative serum thyroglobulin (Tg/LT4) level and after rhTSH to assess its predictive value on the presence of RAI avid lesions in the RAI group and on the rate of excellent response at 3 years in both groups.
    - The excellent response rate at 3 and 5 years after randomization in case of supplemental treatments
    - The predictive values of somatic molecular markers (especially BRAF and TERTp) on the risk of persistent disease
    E.5.2.1Timepoint(s) of evaluation of this end point
    at inclusion, end of diagnostic assessment, end of treatment (for treated patients), 1 year, 3 years and 5 years
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Iode 131 at standard dose
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned27
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Patient followed up to 5 years after randomization
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 476
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 476
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state476
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-01-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-18
    P. End of Trial
    P.End of Trial StatusOngoing
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