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

Phase 2

Active, not recruiting

• Conditions: Thyroid Cancer

• 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.

Study Timeline

• Study First Submitted: 2011-07-06
• Study First Submitted QC: 2011-07-18
• Study First Posted: 2011-07-20
• Study Start: 2012-05
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08
• Primary Completion: 2024-12
• Study Completion: 2031-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 504

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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)

University Hospitals Birmingham NHS Foundation Trust; 🇬🇧 Birmingham, United Kingdom

Brighton and Sussex University Hospitals NHS Trust; 🇬🇧 Brighton, United Kingdom

University Hospital Bristol NHS Foundation Trust; 🇬🇧 Bristol, United Kingdom

Cambridge University Hospitals NHS Foundation Trust; 🇬🇧 Cambridge, United Kingdom

East Kent Hospitals University NHS Foundation Trust; 🇬🇧 Canterbury, 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

NHS Lothian; 🇬🇧 Edinburgh, United Kingdom

Royal Devon and Exeter NHS Trust; 🇬🇧 Exeter, United Kingdom

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