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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Is Ablative Radio-iodine Necessary for Low Risk Differentiated Thyroid Cancer Patients

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 Summary:

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.

Sponsor: University College, London

Current Primary Outcome:

• Phase II: monthly patient accrual rates [ Time Frame: Evaluated within months 7-18 of the trial ]
  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) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Phase III: Cause Specific mortality [ Time Frame: After follow up is complete (estimated year 8-9 of trial) ]
• Phase III: Loco-regional recurrence [ Time Frame: 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: Distant metastases [ Time Frame: 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 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) ]
• Phase III: Adverse events for all patients [ Time Frame: 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: Incidence of second primary tumours [ Time Frame: After follow up is complete (estimated year 8-9 of trial) ]

Original Secondary Outcome:

• Phase III: Cause Specific mortality [ Time Frame: After follow up is complete (estimated year 8-9 of trial) ]
• Phase III: Loco-regional recurrence [ Time Frame: After follow up is complete (estimated year 8-9 of trial) ]
• Phase III: Distant metastases [ Time Frame: After follow up is complete (estimated year 8-9 of trial) ]
• Phase III: Quality of Life [ Time Frame: After follow up is complete (estimated year 8-9 of trial) ]
• Phase III: Adverse events [ Time Frame: After follow up is complete (estimated year 8-9 of trial) ]
• Phase III: Incidence of second primary tumours [ Time Frame: After follow up is complete (estimated year 8-9 of trial) ]

Information By: University College, London

Dates:
Date Received: July 6, 2011
Date Started: May 2012
Date Completion: January 2021
Last Updated: October 25, 2016
Last Verified: October 2016