IoN- Is Ablative Radio-iodine Necessary for Low Risk Differentiated Thyroid Cancer Patients
- Conditions
- Thyroid Cancer
- Interventions
- Radiation: I131 1.1 GBq
- Registration Number
- NCT01398085
- Lead Sponsor
- University College, London
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 504
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Radioactive iodine (RAI) ablation Arm I131 1.1 GBq Patients will be randomised to receive Radioactive iodine (RAI) ablation I131 1.1 GBq
- Primary Outcome Measures
Name Time Method Phase III: Disease-free thyroid specific survival From randomisation until recurrence or death from thyroid cancer DFS measured from randomisation until date of recurrence or death from thyroid cancer
Phase II: monthly patient accrual rates Evaluated within months 7-18 of the trial To determine if recruitment into a phase III trial is feasible
- Secondary Outcome Measures
Name Time Method Phase III: Stage of cancer at the time of recurrence, and the ability to treat this successfully 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 difference in the stage of cancer at the time of recurrence, and the ability to treat this successfully.
Phase III: Further neck surgery After follow up is complete (estimated year 8-9 of trial) The number of further neck surgeries will be collected for patients in both groups during follow up and the groups compared during analysis.
Phase III: Health-related quality of life After follow up is complete (estimated year 8-9 of trial) Quality of Life
Phase III: Cost-effectiveness After follow up is complete (estimated year 8-9 of trial) Costs of treatment for both groups will be collected for duration of trial to see if there is a difference between the two.
Phase III: Mortality (cause and date of death) From randomisation until death Cause and date of death
Phase III: Adverse events for all patients 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: Occurrence of loco-regional recurrence or metastatic disease 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: Further RAI ablations After follow up is complete (estimated year 8-9 of trial) Further RAI ablation and the reasons for this
Trial Locations
- Locations (32)
Portsmouth Hospitals NHS Trust
🇬🇧Portsmouth, United Kingdom
East Kent Hospitals University NHS Foundation Trust
🇬🇧Canterbury, United Kingdom
University College London Hospitals NHS Foundation Trust
🇬🇧London, United Kingdom
Barts Health NHS Trust
🇬🇧London, United Kingdom
NHS Lothian
🇬🇧Edinburgh, United Kingdom
University Hospital Bristol NHS Foundation Trust
🇬🇧Bristol, United Kingdom
Brighton and Sussex University Hospitals NHS Trust
🇬🇧Brighton, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
🇬🇧Cambridge, United Kingdom
Mid Essex Hospitals Services NHS Trust
🇬🇧Chelmsford, United Kingdom
Gloucestershire Hospitals NHS Trust
🇬🇧Cheltenham, United Kingdom
Royal Derby hospital NHS foundation trust
🇬🇧Derby, United Kingdom
Glasgow and Clyde NHS Trust
🇬🇧Glasgow, United Kingdom
The Royal Surrey County Hospital NHS Foundation Trust
🇬🇧Guildford, United Kingdom
Ipswich Hospital NHS Trust
🇬🇧Ipswich, United Kingdom
University Hospitals of Leicester NHS Trust
🇬🇧Leicester, United Kingdom
Royal Marsden NHS Foundation Trust
🇬🇧London, United Kingdom
Guys and St Thomas' NHS Foundation Trust
🇬🇧London, United Kingdom
South Tees Hospitals NHS Trust
🇬🇧Middlesbrough, United Kingdom
Maidstone and Tunbridge Wells NHS Trust
🇬🇧Maidstone, United Kingdom
Newcastle upon Tyne Hospitals NHS Foundation Trust
🇬🇧Newcastle, United Kingdom
Nottingham University Hospitals NHS Trust
🇬🇧Nottingham, United Kingdom
Norfolk and Norwich University Hospitals NHS Trust
🇬🇧Norwich, United Kingdom
Southend University Hospitals NHS Trust
🇬🇧Southend, United Kingdom
Royal Wolverhampton NHS Trust
🇬🇧Wolverhampton, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
🇬🇧Birmingham, United Kingdom
Royal Devon and Exeter NHS Trust
🇬🇧Exeter, United Kingdom
Leeds Teaching Hospitals NHS Trust
🇬🇧Leeds, United Kingdom
Imperial College Healthcare NHS Trust
🇬🇧London, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
🇬🇧Sheffield, United Kingdom
The Christie NHS Foundation Trust
🇬🇧Manchester, United Kingdom
Velindre NHS Trust
🇬🇧Nantgarw, United Kingdom
East and North Herts
🇬🇧Stevenage, United Kingdom