IoN- Is Ablative Radio-iodine Necessary for Low Risk Differentiated Thyroid Cancer Patients (NCT01398085) | Clinical Trial Compass
Active — Not RecruitingPhase 2/3
IoN- Is Ablative Radio-iodine Necessary for Low Risk Differentiated Thyroid Cancer Patients
United Kingdom504 participantsStarted 2012-06-26
Plain-language 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.
Who can participate
Age range16 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
TNM eligibility is assessed against TNM7 (7th edition 2009) or TNM8 (8th edition 2017, in use in the UK from 01/01/2018).
Eligibility Criteria using TNM7:
Inclusion criteria:
* Histological confirmation of well differentiated thyroid carcinoma: MDT decision for inclusion based on overall clinico-pathological assessment is critical.
* R0 total thyroidectomy (in one or two stages, no residual disease present; Rx at the discretion of the MDT) 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:MDT decision for inclusion based on overall clinico-pathological assessment
* Papillary thyroid cancer (PTC):
* Non aggressive histological features (small foci of aggressive histology allowed at the discretion of the MDT)
* pT1a (≤1cm) unifocal with positive level VI lymph nodes (pN1a)
* pT1a(m): all individual foci ≤1cm
* pT1b and pT1b(m): \>1-2cm
* pT2 and pT2(m): \>2-4cm
* pT3 and pT3(m): \>4cm confined to the thyroid
* pT3 R0 +/- (m): any size with minimal ETE if recommended by the MDT
* pN0
* pN1a
* pNX
* Follicular thyroid cancer (FTC) (including oncocytic or HĂĽrthle cell cancer):
o minimally invasive FTC -which are considered low risk and are recommended by the specialist MDT based on overall clinico-pathological assessment
* pT1b and pT2: \>1-4cm intrathyroidal
* pT3 R0:any size up to 4 cm wi…
What they're measuring
1
Phase II: monthly patient accrual rates
Timeframe: Evaluated within months 7-18 of the trial
2
Phase III: Disease-free thyroid specific survival
Timeframe: From randomisation until recurrence or death from thyroid cancer