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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 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: July 21, 2014
Last verified: July 2014
  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 I131 1.1 GBq
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
University Hospitals Birmingham NHS Foundation Trust Recruiting
Birmingham, United Kingdom
Principal Investigator: Hisham Mehanna         
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         
Mid Essex Hospitals Services NHS Trust Recruiting
Chelmsford, United Kingdom
Principal Investigator: Abdel Hamid         
Gloucestershire Hospitals NHS Trust Recruiting
Cheltenham, United Kingdom
Principal Investigator: Charles Candish         
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         
Imperial College Healthcare NHS Trust Recruiting
London, United Kingdom, W6 8RF
Principal Investigator: Danielle Power         
University College London Hospitals NHS Foundation Trust Recruiting
London, United Kingdom
Principal Investigator: Mark Gaze         
Royal Marsden NHS Foundation Trust Recruiting
London, United Kingdom, SW3 6JJ
Principal Investigator: Kate Newbold         
Guys and St Thomas' NHS Foundation Trust Recruiting
London, United Kingdom
Principal Investigator: Hosahalli Mohan         
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         
Portsmouth Hospitals NHS Trust Recruiting
Portsmouth, United Kingdom
Principal Investigator: Dae Kim         
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         
Royal Wolverhampton NHS Trust Recruiting
Wolverhampton, United Kingdom
Principal Investigator: Laura Petitt         
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: July 21, 2014
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 System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
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 September 16, 2014