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    Summary
    EudraCT Number:2011-000144-21
    Sponsor's Protocol Code Number:UCL/10/0299
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2011-07-21
    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 ConcernedUK - MHRA
    A.2EudraCT number2011-000144-21
    A.3Full title of the trial
    ION– Is ablative radiOiodine Necessary for low risk differentiated thyroid cancer patients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ION– Is ablative radiOiodine Necessary for low risk differentiated thyroid cancer patients
    A.3.2Name or abbreviated title of the trial where available
    IoN
    A.4.1Sponsor's protocol code numberUCL/10/0299
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN80416929
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01398085
    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 SponsorUniversity College London
    B.1.3.4CountryUnited Kingdom
    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 supportCancer Research UK
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCRUK & UCL Cancer Trials Centre
    B.5.2Functional name of contact pointIoN trial coordinator
    B.5.3 Address:
    B.5.3.1Street AddressCancer Research UK & UCL Cancer Trials Centre
    B.5.3.2Town/ city90 Tottenham Court Road
    B.5.3.3Post codeW1T 4TJ
    B.5.4Telephone number020 7679 9392
    B.5.5Fax number020 7679 9871
    B.5.6E-mailctc.ion@ucl.ac.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.1.1Trade name Radioactive Iodine (Sodium iodide)
    D.2.1.1.2Name of the Marketing Authorisation holderGE Healthcare Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.1Product nameRadioactive Iodine
    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 [I131] Iodide
    D.3.9.1CAS number 7790-26-3
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit GBq gigabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with differentiated thyroid cancer who are classed as low risk
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10016935
    E.1.2Term Follicular thyroid cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10065861
    E.1.2Term Hurthle cell neoplasm of the thyroid
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10033701
    E.1.2Term Papillary 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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The principal research question for the phase II part of the trial is to determine if the recruitment rate to carry out a phase III trial is feasible.

    The principal research question for the phase III trial is to determine whether patient survival rates are no worse (non-inferior) for patients that do not receive Radioactive Iodine (RAI) ablation compared to those that do.
    E.2.2Secondary objectives of the trial
    The secondary research questions are:
    1. How many patients die from thyroid cancer?
    2. How many patients have a local recurrence of their cancer (cancer found near the location of thyroid)?
    3. How many patients have distant metastatic recurrence of their cancer (cancer found in a location away from the thyroid)?
    4. How many patients will have further surgery?
    5. How many patients will have further radioiodine?
    6. How many patients will have delayed radioiodine treatment in the no-ablation group?
    7. What investigations will be required to confirm recurrence?
    8. The quality of life of patients, this will assess how people are feeling and how they are coping with their treatment and its affects at various stages of the study.
    9. How many patients develop a new type of cancer (non-thyroid cancer)?
    10. Any side affects (adverse events) that may be caused by receiving Radioactive Iodine (RAI) ablation
    11. Is it cost effective to give, or to not give ra
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. R0 total thyroidectomy completed within 6 months prior to randomisation(for 2 stage TTs only the second stage must have been carried out within the 6 month timeframe)
    2. Negative pregnancy test in women of child bearing potential
    3. Aged 16 or over
    4. WHO performance status 0 – 2, self- caring
    5. Histological confirmation of differentiated thyroid carcinoma:
    Papillary thyroid cancer
    a. Non aggressive histological features (small foci of aggressive histology allowed)
    b. pT1a(m): all individual foci ≤1cm, intrathyroidal
    c. pT1b and pT1b(m): >1-2cm, intrathyroidal
    d. pT2 and pT2(m):>2-4cm, intrathyroidal
    e. pT3 and pT3(m): .4cm, inrtathyroidal, or any size with minimal extrathyroidal extension
    f. pN0
    g. pN1a
    h. pNX
    i. Encapsulated Follicular Variant of Papillary Thyroid Cancer (EFVPTC) with capsular invasion only
    Follicular thyroid cancer/ Hürthle cell cancer (minimally invasive with capsular invasion only)
    a. pT1b: >1-2cm ,intrathyroidal
    b. pT2: >2-4cm, intrathyroidal
    E.4Principal exclusion criteria
    1. pT1a - Papillary and Follicular carcinoma which is unifocal and ≤ 1cm in size
    2. Encapsulated Follicular Variant of Papillary Thyroid Cancer (EFVPTC) that is:
    a. non-invasive (no capsular or vascular invasion)
    b. angio invasive (with definite vascular invasion)
    3. Anaplastic or medullary carcinoma
    4. R1 Thyroidectomy
    5. Patients with:
    a. pN1b
    b. M1
    6. Aggressive Papillary thyroid cancer with the following features:
    a. Angio invasive
    b. Widely invasive
    c. Poorly differentiated
    d. Anaplastic differentiation
    e. Tall cell
    f. Columnar cell
    g. Diffuse sclerosing variants
    7. Follicular thyroid cancer/ Hürthle cell cancer with the following features:
    a. Angio invasive
    b. Widely invasive
    c. Poorly differentiated
    d. Tumours greater than 4cm
    8. Incomplete resection/ lobectomy
    9. Macroscopic and microscopic tumour invasion of locoregional tissues or structures
    10. Pregnant women or women who are lactating
    11. Patients who have CT performed with iv contrast less than 3 months before ablation
    12. Previous treatment for thyroid cancer (except surgery)
    13. Previous malignancies with limited life expectancy or likely to interfere with the patient’s ability to be able to comply with treatment and/or follow-up at least for 5 years
    14. Dysphagia
    15. Oesophageal stricture
    16. Active gastritis
    17. Gastric erosions
    18. Peptic ulcer
    19. Suspected reduced gastrointestinal motility
    20. Severe co-morbid condition/s that would prevent ablation including:
    a. Unstable angina
    b. Recent myocardial infarction or cerebrovascular accident (CVA)
    c. Severe labile hypertension
    d. Any patient who cannot comply with radiation protection including:
    i. patients with learning difficulties
    ii. patients with dementia
    iii. patients with a tracheostomy that require nursing care
    iv. patients requiring frequent nursing/ medical supervision
    E.5 End points
    E.5.1Primary end point(s)
    Phase II: monthly patient accrual rates

    Phase III: 5-year disease-free survival (residual and recurrent)
    E.5.2Secondary end point(s)
    Cause Specific mortality
    Occurrence of Loco-regional recurrence
    Metastastic disease
    Quality of Life
    Adverse events
    Incidence of second primary tumours
    Incidence of further neck surgery
    Incidence of further RAI ablation
    E.5.2.1Timepoint(s) of evaluation of this end point
    Phase II accrual rates will be evaluated between 7- 18 months to allow for sites setup and will ensure recruitment is feasible before moving to phase III.

    Phase III secondary endpoints will be evaluated when the primary endpoint is evaluated.
    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) Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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
    Patients on the comparator arm will not receive radioactive iodine ablation
    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 concerned30
    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 Yes
    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
    The end of the trial will be declared after the last patient recruited has had 5 years of follow-up.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years9
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days17
    E.8.9.2In all countries concerned by the trial years9
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days17
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 4
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 4
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 532
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 34
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state570
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 570
    F.4.2.2In the whole clinical trial 570
    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)
    No arrangements are required. Radioactive Iodine is not being supplied as part of the study.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-10-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-15
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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