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

This study is currently recruiting participants.
Verified December 2013 by University College, London
Sponsor:
Collaborator:
Cancer Research UK
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT01398085
First received: July 6, 2011
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Thyroid Cancer
Radiation: I131 1.1 GBq
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Is Ablative Radio-iodine Necessary for Low Risk Differentiated Thyroid Cancer Patients

Resource links provided by NLM:


Further study details as provided by University College, London:

Primary Outcome Measures:
  • Phase II: monthly patient accrual rates [ Time Frame: Evaluated within months 7-18 of the trial ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Phase III: Cause Specific mortality [ Time Frame: After follow up is complete (estimated year 8-9 of trial) ] [ Designated as safety issue: No ]
  • Phase III: Loco-regional recurrence [ Time Frame: After follow up is complete (estimated year 8-9 of trial) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
  • Phase III: Adverse events for all patients [ Time Frame: After follow up is complete (estimated year 8-9 of trial) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 570
Study Start Date: May 2012
Estimated Study Completion Date: January 2021
Estimated Primary Completion Date: November 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Radioactive iodine (RAI) ablation Arm
Patients will be randomised to receive Radioactive iodine (RAI) ablation 1.1 GBq I131
Radiation: I131 1.1 GBq
Radio-iodine
Other Name: Sodium iodide capsule
No Intervention: No Radioactive iodine (No-RAI) ablation
Patients will be randomised to receive No Radioactive iodine (No-RAI) ablation

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • R0 total thyroidectomy (in one or two stages, no residual disease present) 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:
  • Papillary thyroid cancer

    • Non aggressive histological features (small foci of aggressive histology allowed)
    • PT1a(m): all individual foci ≥1cm, intrathyroidal
    • pT1b and pT1b(m): >1-2cm, intrathyroidal
    • pT2 and pT2(m): >2-4cm, intrathyroidal
    • pT3 and pT3(m): >4cm, intrathyroidal, or any size with minimal extrathyroidal spread
    • pN0
    • pN1a
    • pNX
    • Encapsulated follicular variant of papillary thyroid cancer (EFVPTC) with capsular invasion only
    • Follicular thyroid cancer/ Hürthle cell cancer
    • minimally invasive with capsular invasion only
    • pT1b: >1- 2 cm
    • pT2: >2-4cm, intrathyroidal

Exclusion Criteria:

  • Papillary and Follicular carcinoma which is unifocal and ≤1cm in size
  • Encapsulated Follicular Variant of Papillary Thyroid Cancer (EFVPTC) that is:

    • non-invasive (no capsular or vascular invasion)
    • angio invasive (with definite vascular invasion)
  • Anaplastic or medullary carcinoma
  • R1 Thyroidectomy
  • Patients with:

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

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

    • Angio invasive
    • Widely invasive
    • Poorly differentiated
    • Tumours greater than 4cm
  • Incomplete resection/ lobectomy
  • Macroscopic and microscopic tumour invasion of locoregional tissues or structures
  • Pregnant women or women who are lactating
  • Patients who have CT performed with iv contrast less than 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
  • Severe co-morbid condition/s that would prevent ablation including:

    • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01398085

Contacts
Contact: Dymphna Lee 020 7679 9392 ion@ctc.ucl.ac.uk
Contact: Sharon Forsyth 020 7679 9264 ion@ctc.ucl.ac.uk

Locations
United Kingdom
Belfast and Social Care Trust Not yet recruiting
Belfast, United Kingdom, BT8 8BH
Principal Investigator: Russell Houston         
University Hospital Bristol NHS Foundation Trust Recruiting
Bristol, United Kingdom, BS1 3NU
Principal Investigator: Matthew Beasley         
Cambridge University Hospitals NHS Foundation Trust Recruiting
Cambridge, United Kingdom, CB2 0QQ
Principal Investigator: Sarah Jefferies         
Royal Derby hospital NHS foundation trust Not yet recruiting
Derby, United Kingdom, DE223NE
Principal Investigator: Rengarajan Vijayan         
Poole Hospital NHS Foundation Trust Recruiting
Dorset, United Kingdom, DT1 2JY
Principal Investigator: Perric Crellin         
NHS Lothian Recruiting
Edinburgh, United Kingdom, EH4 2XU
Principal Investigator: Mark Strachan         
Royal Devon and Exeter NHS Trust Recruiting
Exeter, United Kingdom, EX2 5DW
Principal Investigator: Andy Goodman         
Glasgow and Clyde NHS Trust Recruiting
Glasgow, United Kingdom, G12 0YN
Principal Investigator: Nick Reed         
Ipswich Hospital NHS Trust Recruiting
Ipswich, United Kingdom, IP4 5PD
Principal Investigator: Christopher Scrase         
East Kent Hospitals University NHS Foundation Trust Recruiting
Kent, United Kingdom, CT1 3NG
Principal Investigator: Elena Macias         
Leeds Teaching Hospitals NHS Trust Recruiting
Leeds, United Kingdom, LS9 7TF
Principal Investigator: Georgina Gerrard         
University Hospitals of Leicester NHS Trust Recruiting
Leicester, United Kingdom, LE1 5WW
Principal Investigator: Irene Peat         
University Hospital Aintree NHS Trust Not yet recruiting
Liverpool, United Kingdom, L9 7AL
Principal Investigator: Terry Jones         
Royal Marsden NHS Foundation Trust Recruiting
London, United Kingdom, SW3 6JJ
Principal Investigator: Kate Newbold         
Imperial College Healthcare NHS Trust Recruiting
London, United Kingdom, W6 8RF
Principal Investigator: Danielle Power         
Maidstone and Tunbridge Wells NHS Trust Recruiting
Maidstone, United Kingdom, ME16 9QQ
Principal Investigator: Nick Rowell         
The Christie NHS Foundation Trust Recruiting
Manchester, United Kingdom, M20 4BX
Principal Investigator: Beng Yap         
South Tees Hospitals NHS Trust Recruiting
Middlesbrough, United Kingdom, TS4 3BW
Principal Investigator: John Hardman         
Velindre NHS Trust Recruiting
Nant Garw, United Kingdom, CF15 7QZ
Principal Investigator: Laura Moss         
Newcastle upon Tyne Hospitals NHS Foundation Trust Recruiting
Newcastle, United Kingdom, NE7 7DN
Principal Investigator: Ujjal Mallick         
Norfolk and Norwich University Hospitals NHS Trust Recruiting
Norwich, United Kingdom
Principal Investigator: Tom Roques         
Nottingham University Hospitals NHS Trust Recruiting
Nottingham, United Kingdom, NG5 1PB
Principal Investigator: Sally Morgan         
Sheffield Teaching Hospitals NHS Foundation Trust Recruiting
Sheffield, United Kingdom, S10 2SJ
Principal Investigator: Jon Wadsley         
Southend University Hospitals NHS Trust Recruiting
Southend, United Kingdom, SS0 0RY
Principal Investigator: Krishnaswamy Madhavan         
East and North Herts Not yet recruiting
Stevenage, United Kingdom, SG1 4AB
Principal Investigator: Catherine Lemon         
The Royal Surrey County Hospital NHS Foundation Trust Recruiting
Surrey, United Kingdom, GU1 4JW
Principal Investigator: Stephen Whitaker         
Sponsors and Collaborators
University College, London
Cancer Research UK
Investigators
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)
  More Information

Additional Information:
No publications provided

Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT01398085     History of Changes
Other Study ID Numbers: UCL/10/0299, 2011-000144-21, Cancer Research UK, ISRCTN
Study First Received: July 6, 2011
Last Updated: December 17, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University College, London:
Papillary thyroid carcinoma
Follicular thyroid carcinoma
Hurthle cell carcinoma of the thyroid
Iodine Radioisotopes

Additional relevant MeSH terms:
Thyroid Neoplasms
Thyroid Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
Iodine
Cadexomer iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014