ION– Is ablative radiOiodine Necessary for low risk differentiated thyroid cancer patients

• Conditions: Patients with differentiated thyroid cancer who are classed as low risk; MedDRA version: 14.1Level: PTClassification code 10016935Term: Follicular thyroid cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: LLTClassification code 10065861Term: Hurthle cell neoplasm of the thyroidSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: PTClassification code 10033701Term: Papillary thyroid cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2011-000144-21-GB
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-21
• Last Update Posted: 10 June 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 570

Inclusion Criteria

1.R0 total thyroidectomy completed within 6 months prior to randomisation(for 2 stage TTs only the second stage must have been carried out within the 6 month timeframe)
2.Negative pregnancy test in women of child bearing potential
3.Aged 16 or over
4.WHO performance status 0 – 2, self- caring
5.Histological confirmation of differentiated thyroid carcinoma:
Papillary thyroid cancer
a.Non aggressive histological features (small foci of aggressive histology allowed)
b.pT1a(m): all individual foci =1cm, intrathyroidal
c. pT1b and pT1b(m): >1-2cm, intrathyroidal
d.pT2 and pT2(m):>2-4cm, intrathyroidal
e.pT3 and pT3(m): .4cm, inrtathyroidal, or any size with minimal extrathyroidal extension
f.pN0
g.pN1a
h.pNX
i. Encapsulated Follicular Variant of Papillary Thyroid Cancer (EFVPTC) with capsular invasion only
Follicular thyroid cancer/ Hürthle cell cancer (minimally invasive with capsular invasion only)
a.pT1b: >1-2cm ,intrathyroidal
b. pT2: >2-4cm, intrathyroidal

Are the trial subjects under 18? yes
Number of subjects for this age range: 4
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 532
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 34

Exclusion Criteria

1.pT1a - Papillary and Follicular carcinoma which is unifocal and = 1cm in size
2.Encapsulated Follicular Variant of Papillary Thyroid Cancer (EFVPTC) that is:
a.non-invasive (no capsular or vascular invasion)
b.angio invasive (with definite vascular invasion)
3.Anaplastic or medullary carcinoma
4.R1 Thyroidectomy
5.Patients with:
a.pN1b
b.M1
6.Aggressive Papillary thyroid cancer with the following features:
a.Angio invasive
b.Widely invasive
c.Poorly differentiated
d.Anaplastic differentiation
e.Tall cell
f.Columnar cell
g.Diffuse sclerosing variants
7.Follicular thyroid cancer/ Hürthle cell cancer with the following features:
a.Angio invasive
b.Widely invasive
c.Poorly differentiated
d.Tumours greater than 4cm
8.Incomplete resection/ lobectomy
9.Macroscopic and microscopic tumour invasion of locoregional tissues or structures
10.Pregnant women or women who are lactating
11.Patients who have 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 at least for 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:
a.Unstable angina
b.Recent myocardial infarction or cerebrovascular accident (CVA)
c.Severe labile hypertension
d.Any patient who cannot comply with radiation protection including:
i.patients with learning difficulties
ii.patients with dementia
iii.patients with a tracheostomy that require nursing care
iv.patients requiring frequent nursing/ medical supervision

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified