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IoN- Is Ablative Radio-iodine Necessary for Low Risk Differentiated Thyroid Cancer Patients (IoN)

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ClinicalTrials.gov Identifier: NCT01398085
Recruitment Status : Recruiting
First Posted : July 20, 2011
Last Update Posted : October 26, 2016
Sponsor:
Collaborator:
Cancer Research UK
Information provided by (Responsible Party):
University College, London

July 6, 2011
July 20, 2011
October 26, 2016
May 2012
November 2020   (Final data collection date for primary outcome measure)
  • Phase II: monthly patient accrual rates [ Time Frame: Evaluated within months 7-18 of the trial ]
    To determine if recruitment into a phase III trial is feasible
  • Phase III: 5-year disease-free survival (residual and recurrent) [ Time Frame: After follow up is complete (estimated year 8-9 of trial) ]
Same as current
Complete list of historical versions of study NCT01398085 on ClinicalTrials.gov Archive Site
  • Phase III: Cause Specific mortality [ Time Frame: After follow up is complete (estimated year 8-9 of trial) ]
  • Phase III: Loco-regional recurrence [ Time Frame: After follow up is complete (estimated year 8-9 of trial) ]
    Both groups will be compared to ascertain if radio-iodine results in a statistically significant reduction in risk in developing loco-regional recurrence in the low risk subgroup of patients.
  • Phase III: Distant metastases [ Time Frame: After follow up is complete (estimated year 8-9 of trial) ]
    Both groups will be compared to ascertain if radio-iodine results in a statistically significant reduction in risk in developing distant metastases in the low risk subgroup of patients.
  • Phase III: Quality of Life [ Time Frame: After follow up is complete (estimated year 8-9 of trial) ]
  • Phase III: Adverse events for all patients [ Time Frame: After follow up is complete (estimated year 8-9 of trial) ]
    Adverse events will be collected for patients in both groups during treatment and the groups compared during analysis.
  • Phase III: Incidence of second primary tumours [ Time Frame: After follow up is complete (estimated year 8-9 of trial) ]
  • Phase III: Cause Specific mortality [ Time Frame: After follow up is complete (estimated year 8-9 of trial) ]
  • Phase III: Loco-regional recurrence [ Time Frame: After follow up is complete (estimated year 8-9 of trial) ]
  • Phase III: Distant metastases [ Time Frame: After follow up is complete (estimated year 8-9 of trial) ]
  • Phase III: Quality of Life [ Time Frame: After follow up is complete (estimated year 8-9 of trial) ]
  • Phase III: Adverse events [ Time Frame: After follow up is complete (estimated year 8-9 of trial) ]
  • Phase III: Incidence of second primary tumours [ Time Frame: After follow up is complete (estimated year 8-9 of trial) ]
Not Provided
Not Provided
 
IoN- Is Ablative Radio-iodine Necessary for Low Risk Differentiated Thyroid Cancer Patients
Is Ablative Radio-iodine Necessary for Low Risk Differentiated Thyroid Cancer Patients
IoN is a phase II/ III trial that will look to ascertain whether or not radio-iodine ablation is necessary for low risk differentiated thyroid cancer patients.

Phase II: to determine if recruitment into a phase III trial is feasible, with a target of 10 patients per month during a minimum of 6 months (evaluated within months 7-18 of the trial).

Phase III: to determine whether the 5-year disease-free survival rate among patients who do not have routine Radioactive iodine (RAI) ablation is non-inferior to those who do.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Thyroid Cancer
Radiation: I131 1.1 GBq
Radio-iodine
Other Name: Sodium iodide capsule
  • Active Comparator: Radioactive iodine (RAI) ablation Arm
    Patients will be randomised to receive Radioactive iodine (RAI) ablation I131 1.1 GBq
    Intervention: Radiation: I131 1.1 GBq
  • No Intervention: No Radioactive iodine (No-RAI) ablation
    Patients will be randomised to receive No Radioactive iodine (No-RAI) ablation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
570
Same as current
January 2021
November 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • R0 total thyroidectomy (in one or two stages, no residual disease present; Rx at the discretion of the MDT) within the last 6 months
  • Negative pregnancy test in women of child bearing potential
  • Aged 16 or over
  • WHO performance status 0 - 2, self-caring
  • Histological confirmation of differentiated thyroid carcinoma:

MDT decision for inclusion based on overall clinico-pathological assessment

  • Papillary thyroid cancer

    • Non aggressive histological features (small foci of aggressive histology allowed at the discretion of the MDT)
    • pT1a(m): all individual foci ≤1cm
    • pT1b and pT1b(m): >1-2cm
    • pT2 and pT2(m): >2-4cm
    • pT3 and pT3(m): >4cm
    • pT3 R0: any size with minimal extrathyroidal extension recommended by the MDT
    • pN0
    • pN1a
    • pNX
    • Encapsulated follicular variant of papillary thyroid cancer (EFVPTC) with capsular invasion only
  • Follicular thyroid cancer/ Hurthle cell cancer

    • minimally invasive with capsular invasion only (or up to four foci of possible invasion of intra - capsular vessels at the discretion of the MDT only)
    • pT1b: >1- 4 cm
    • pT3 R0: (up to 4cm only) with minimal extrathyroidal extension recommended by the MDT
  • Histological material available for Central Review
  • Willing to use contraception for the duration of the trial until 6 months post radioiodine treatment (for females) or 4 months post treatment (for males), if allocated to the ablation group.

N.B. Multifocal tumours (≥2 foci) of all histological types should be designated with "(m)", and the size of the largest focus determines the classification (as described in the TNM 7th edition). For example, if there are two foci, one 0.8cm and the other 3cm, the classification is based on the 3cm focus; i.e. pT2(m).

Exclusion Criteria:

  • pT1a - Papillary and Follicular carcinoma which is unifocal and ≤1cm in size
  • <4cm Encapsulated Follicular Variant of Papillary Thyroid Cancer (EFVPTC) with no capsular invasion
  • Anaplastic or medullary carcinoma
  • R1/R2 Thyroidectomy
  • Patients with:

    • pN1b
    • M1
  • Aggressive Papillary thyroid cancer with any of the following features:

    • Widely invasive
    • Poorly differentiated
    • Anaplastic
    • Tall cell
    • Columnar cell
    • Diffuse sclerosing variants
  • Follicular thyroid cancer/ Hürthle cell cancer with any of the following features:

    • Anaplastic
    • Widely invasive
    • Poorly differentiated
    • Tumours greater than 4cm
  • Incomplete resection or lobectomy
  • pT4 or macroscopic and microscopic tumour invasion of locoregional tissues or structures
  • Pregnant women or women who are breast feeding
  • Patients who have CT performed with iv contrast less than 2-3 months before ablation
  • Previous treatment for thyroid cancer (except surgery)
  • 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
  • Dysphagia, Oesophageal stricture, Active gastritis,Gastric erosions, Peptic ulcer, Suspected reduced gastrointestinal motility
  • MDT decision against ablation or suitability for trail in the light of severe co-morbid condition/s:

    • Unstable angina
    • Recent myocardial infarction or cerebrovascular accident (CVA)
    • Severe labile hypertension
    • Any patient who cannot comply with radiation protection including:

      • patients with learning difficulties
      • patients with dementia
      • patients with a tracheostomy that require nursing care
      • patients requiring frequent nursing/ medical supervision
Sexes Eligible for Study: All
16 Years and older   (Child, Adult, Older Adult)
No
Contact: Steven Davis 020 7679 9241 ion@ctc.ucl.ac.uk
Contact: Sharon Forsyth 020 7679 9264 ion@ctc.ucl.ac.uk
United Kingdom
 
 
NCT01398085
UCL/10/0299
2011-000144-21 ( EudraCT Number )
Cancer Research UK ( Other Grant/Funding Number: CRUK/11/010 )
ISRCTN ( Registry Identifier: ISRCTN80416929 )
No
Not Provided
Not Provided
University College, London
University College, London
Cancer Research UK
Principal Investigator: Ujjal Mallick, MBBS, Master of Surgery, FRCR Newcastle-upon-Tyne Hospitals NHS Foundation Trust
Study Director: Jonathan Ledermann University College London (Joint UCLH & UCL Biomedical Research Unit)
University College, London
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP