ION - Is ablative radiOiodine Necessary for low risk differentiated thyroid cancer patients?
| ISRCTN | ISRCTN80416929 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80416929 |
| EudraCT/CTIS number | 2011-000144-21 |
| IRAS number | 75777 |
| ClinicalTrials.gov number | NCT01398085 |
| Secondary identifying numbers | UCL/10/0299, IRAS 75777 |
- Submission date
- 11/01/2011
- Registration date
- 03/03/2011
- Last edited
- 22/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Contact information
Ms Emily Ambrose
Scientific
Scientific
Cancer Research UK & UCL Cancer Trials Centre
90 Tottenham Court Road
London
W1T 4TJ
United Kingdom
| Phone | +44 (0)20 7679 9392 |
|---|---|
| ion@ctc.ucl.ac.uk |
Study information
| Study design | Randomized non-blind non-inferiority Phase II/III multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Randomised trial comparing total thyroidectomy, thyriod stimulating hormone (TSH) suppression and radioactive iodine ablation with total thyroidectomy and TSH suppression, in low-risk patients with thyroid cancer |
| Study acronym | ION |
| Study hypothesis | Phase II: To determine if recruitment into a phase III trial is feasible, with a target of 10 patients per month during a minimum period of 6 months (evaluated within months 7 - 18 of the trial). Phase III: To determine whether the 5-year recurrence-free survival rate among patients who do not have routine radioactive iodine (RAI) ablation is non-inferior to those that do. As of 06/06/2012, the following changes have been made to the trial. Anticipated start date has been updated from 02/05/2011 to 16/05/2012. Anticipated end date has been updated from 05/05/2015 to 16/05/2021 (includes recruitment and follow up phase). Target number of participants has been increased from 550 to 570. |
| Ethics approval(s) | Added as of 06/06/2012 North East - Newcastle and Tyneside REC approved on 15/09/2011 (ref: 11/NE/0228) Birmingham Research Ethics Committee (REC) approval pending as of 12/01/2011 |
| Condition | Differentiated thyroid cancer |
| Intervention | Following surgery, eligible patients will be approached for consent. Those who agree will be randomised to one of the following groups: 1. Radioactive iodine (RAI) ablation arm (1.1 GBq), or 2. No radioactive iodine (NO-RAI) ablation arm Total duration of treatment will be from randomisation to last scan (8 - 9 months), and follow-up will be for 5 years. Chief investigator contact details: Dr Ujjal Mallick Freeman Road High Heaton Newcastle NE7 7DN |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II/III |
| Drug / device / biological / vaccine name(s) | Radioactive iodine |
| Primary outcome measure | 1. Phase II: monthly patient accrual rates, evaluated 7 - 18 months after the start. There will then be a decision on whether to proceed to phase III or not 2. Phase III: 5-year recurrence-free survival, evaluated after the last patient has their last follow-up or sooner depending on the data |
| Secondary outcome measures | Current secondary outcome measure (s) as of 06/06/2012: Phase III only (evaluated by the statistician at the final analysis at the end of the study): 1. Quality of life (E5-QD, QLQ-C30, H&N35) 2. Adverse events (Common Toxicity Criteria for Adverse Events [CTCAE]) 3. Thyroid cancer mortality 4. Loco-regional recurrence 5. Distant metastases 6. Incidence of second primary tumours Analysis will depend on recruitment but if the trial goes to phase III we expect all patients to be recruited in 3 - 4 years so last visit and analysis will be 8-9 years after the start. Previous secondary outcome measure (s): Phase III only (evaluated by the statistician at the final analysis at the end of the study): 1. Quality of life (E5-QD and SF-36) 2. Adverse events (Common Toxicity Criteria for Adverse Events [CTCAE]) 3. Thyroid cancer mortality 4. Loco-regional recurrence 5. Distant metastases 6. Incidence of second primary tumours Analysis will depend on recruitment but if the trial goes to phase III we expect all patients to be recruited in 3 - 4 years so last visit and analysis will be 8-9 years after the start. |
| Overall study start date | 16/05/2012 |
| Overall study end date | 31/03/2031 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | 570 |
| Total final enrolment | 504 |
| Participant inclusion criteria | Current inclusion criteria as of 06/06/2012 1. R0 total thyroidectomy (in 1 or 2 stages, no residual disease present) 2. Negative pregnancy test in females of child bearing potential 3. Aged 16 years or over 4. WHO performance status 0 2, self caring 5. Histological confirmation of differentiated thyroid carcinoma 6. Papillary thyroid cancer: 6.1 Non agressive histological features (small foci of agressive histology allowed) 6.2 pT1b, 1-2cm intrathyroidal 6.3 pT2, 2-4cm intrathyroidal 6.4 pT3 intrathyroidal only 6.5 Multifocal carcinoma 6.6 pN0 6.7 pN1a 6.8 pNX 7. Follicular thyroid cancer/Hürthle cell cancer (minimally invasive with capsular invasion only 7.1 pT1b (1-2cm) pT2 (2-4cm) intrathyroidal Previous inclusion criteria 1. Negative pregnancy test in females of child bearing potential 2. Aged 16 years or over, either sex 3. World Health Organization (WHO) performance status 0 2 4. R0 total thyroidectomy (in 1 or 2 stages, no residual disease present) 5. Histological confirmation of differentiated thyroid carcinoma 6. Papillary thyroid cancer: 6.1. Non aggressive histological features (small foci allowed) 6.2. T1b, 1 - 2 cm, intrathyroidal 6.3. T2, 2 - 4 cm, intrathyroidal 6.4. T3, intrathyroidal 6.5. No vascular invasion 6.6. Multifocal microcarcinoma 6.7. N0 6.8. N1a 6.9. NX 7. Follicular thyroid cancer/Hürthle cell cancer: 7.1. Minimally invasive (capsular invasion only) 7.2. Tumours 2 cm or less 7.3. N0 7.4. N1a 7.5. NX |
| Participant exclusion criteria | Current exclusion criteria as of 06/06/2012 1. Papillary and Follicular carcinoma which is unifocal and <1cm in size 2. Encapsulated Follicular Variant of Papillary Thyroid Cancer (EFVPTC) that is: 2.1. non-invasive 2.2. angio-invasive 3. Anaplastic or medullary carcinoma 4. R1 thyroidectomy 5. Patients with: 5.1 pN1b 5.2 M1 6. Aggressive Papillary thyroid cancer with the following features: 6.1 Angio-invasive 6.2 Widely invasive 6.3 Poorly differentiated 6.4 Anaplastic differentiation 6.5 Tall cell 6.6 Columnar cell 6.7 Diffuse sclerosing variants 7. Follicular thyroid cancer/Hürthle cell cancer with the following features: 7.1. Angio-invasive 7.2. Widely invasive 7.3. Poorly differentiated 7.4. Tumours greater than 4cm 8. Incomplete resection/lobectomy 9. Macroscopic and microscopic tumour invasion of locoregional tissues or structures 10. Women who are lactating 11. Patients who have had CT performed with iv contrast less than 3 months before ablation 12. Previous treatment for thyroid cancer (except surgery) 13. 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 for at least 5 years 14. Dysphagia 15. Oesophageal stricture 16. Active gastritis 17. Gastric erosions 18. Peptic ulcer 19. Suspected reduced gastrointestinal motility 20. Severe co-morbid condition/s that would prevent ablation including: 20.1. Unstable angina 20.2. Recent myocardial infarction or cerebrovascular accident (CVA) 20.3. Severe labile hypertension 21. Any patient who cannot comply with radiation protection including: 21.1. patients with learning difficulties 21.2. patients with dementia 21.3. patients with a tracheostomy that require nursing care 21.4. patients requiring frequent nursing/ medical supervision Previous exclusion criteria 1. Pregnant women or women who are breastfeeding 2. Patients who have computed tomography (CT) performed with intravenous (iv) contrast less than 3 months before ablation 3. Previous treatment for thyroid cancer (not including surgery) 4. Incomplete resection/lobectomy 5. Local or distant metastases at diagnosis 6. Macroscopic and microscopic tumour invasion of locoregional tissues or structures 7. Anaplastic or medullary carcinoma 8. Patients with: 8.1. N1b 8.2. M1 9. Previous malignancies with limited life expectancy likely to interfere with the patient's ability to be able to comply with treatment and/or follow-up 10. Severe co-morbid condition/s that would prevent ablation including: 10.1. Unstable angina 10.2. Recent myocardial infarction or cerebrovascular accident (CVA) 10.3. Severe labile hypertension 10.4. Any patient who cannot comply with radiation protection including: 10.4.1. Patients with learning difficulties 10.4.2. Patients with dementia 10.4.3. Patients with a tracheotomy that require nursing care 10.4.4. Patients requiring frequent nursing/ medical supervision 11. Papillary thyroid cancer that is: 11.1. Widely invasive 11.2. Poorly differentiated 11.3. Tall cell 11.4. Columnar cell 11.5. Diffuse sclerosing variants 12. Follicular thyroid cancer/Hürthle cell cancer that is: 12.1. Widely invasive 12.2. Poorly differentiated 12.3. Tumours greater than 2 cm 12.4. Diffuse sclerosing variants |
| Recruitment start date | 16/05/2012 |
| Recruitment end date | 30/03/2020 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Cancer Research UK & UCL Cancer Trials Centre
London
W1T 4TJ
United Kingdom
W1T 4TJ
United Kingdom
Sponsor information
University College London (UCL) (UK)
University/education
University/education
1st Floor Maple House
149 Tottenham Court Road
London
W1T7DN
England
United Kingdom
| Website | http://www.ucl.ac.uk/joint-rd-unit/ |
|---|---|
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Charity
Cancer Research UK (CRUK) (UK)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The final analysis is planned to be carried out in December 2023. Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from IoN trial manager (ctc.ion@ucl.ac.uk). The type of data that will be shared: this will be dependent on the request and the data that the patient has consented to When the data will become available and for how long: to be confirmed By what access criteria data will be shared including with whom: researchers who wish to access data should contact the CTC (email address above) For what types of analyses, and by what mechanism: will be assessed on a case-by-case basis Whether consent from participants was obtained: consent was given to collect the data. Data cannot be shared if patients withdrew consent to data collection/use. Comments on data anonymisation: data will be pseudonymised Any ethical or legal restrictions: research for the data request should be ethically approved |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
22/11/2023: Total final enrolment, publication and dissemination plan, and IPD sharing plan added.
03/11/2023: IRAS number added, contact details updated.
21/05/2021: The overall trial end date has been changed from 16/05/2021 to 31/03/2031.
15/05/2020: The recruitment end date has been changed from 16/05/2021 to 30/03/2020.
