IoN- Is Ablative Radio-iodine Necessary for Low Risk Differentiated Thyroid Cancer Patients
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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 |
- 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 ]
- 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 |
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)
- pT1b (1-2cm), intrathyroidal
- pT2 (2-4cm), intrathyroidal
- pT3, intrathyroidal only
- Multifocal microcarcinoma
- pN0
- pN1a
- pNX
Follicular thyroid cancer/ Hürthle cell cancer (minimally invasive with capsular invasion only)
- pT1b (1- 2cm), 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
- angio invasive
- 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| Contact: Dymphna Lee | 020 7679 9392 | ion@ctc.ucl.ac.uk |
| Contact: Sharon Forsyth | 020 7679 9264 | ion@ctc.ucl.ac.uk |
| 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 | Not yet 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 | Not yet recruiting |
| Dorset, United Kingdom, DT1 2JY | |
| Principal Investigator: Perric Crellin | |
| NHS Lothian | Not yet recruiting |
| Edinburgh, United Kingdom, EH4 2XU | |
| Principal Investigator: Mark Strachan | |
| Royal Devon and Exeter NHS Trust | Not yet recruiting |
| Exeter, United Kingdom, EX2 5DW | |
| Principal Investigator: Andy Goodman | |
| Glasgow and Clyde NHS Trust | Not yet recruiting |
| Glasgow, United Kingdom, G12 0YN | |
| Principal Investigator: Nick Reed | |
| Ipswich Hospital NHS Trust | Not yet 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 | Not yet recruiting |
| Leeds, United Kingdom, LS9 7TF | |
| Principal Investigator: Georgina Gerrard | |
| University Hospitals of Leicester NHS Trust | Not yet 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 | Not yet recruiting |
| London, United Kingdom, W6 8RF | |
| Principal Investigator: Danielle Power | |
| Maidstone and Tunbridge Wells NHS Trust | Not yet recruiting |
| Maidstone, United Kingdom, ME16 9QQ | |
| Principal Investigator: Nick Rowell | |
| The Christie NHS Foundation Trust | Not yet recruiting |
| Manchester, United Kingdom, M20 4BX | |
| Principal Investigator: Beng Yap | |
| South Tees Hospitals NHS Trust | Not yet recruiting |
| Middlesbrough, United Kingdom, TS4 3BW | |
| Principal Investigator: John Hardman | |
| Velindre NHS Trust | Not yet 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 | |
| Nottingham University Hospitals NHS Trust | Not yet recruiting |
| Nottingham, United Kingdom, NG5 1PB | |
| Principal Investigator: Sally Morgan | |
| Sheffield Teaching Hospitals NHS Foundation Trust | Not yet recruiting |
| Sheffield, United Kingdom, S10 2SJ | |
| Principal Investigator: Jon Wadsley | |
| 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 | |
| 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: | June 7, 2012 |
| 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 June 18, 2013