Is ablative radioiodine Necessary for low risk differentiated thyroid cancer patients
- Conditions
- Neoplasms
- Registration Number
- KCT0003216
- Lead Sponsor
- ational Cancer Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 200
• Histological confirmation of differentiated thyroid carcinoma:MDT decision for inclusion based on overall clinico-pathological assessment
• 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 20 or over
• WHO performance status 0 - 2, self-caring
• Papillary thyroid cancer
o Non aggressive histological features (small foci of aggressive histology allowed at the discretion of the MDT)
o pT1a(m): all individual foci =1cm
o pT1b and pT1b(m): >1-2cm
o pT2 and pT2(m): >2-4cm
o pT3 and pT3(m): >4cm
o pT3 R0: any size with minimal extrathyroidal extension recommended by the MDT
o pN0
o pN1a
o pNX
• Encapsulated follicular variant of papillary thyroid cancer (EFVPTC) with capsular invasion only
• Follicular thyroid cancer/ Hurthle cell cancer
o minimally invasive with capsular invasion only (or up to four foci of possible invasion of intra - capsular vessels at the discretion of the MDT only)
- pT1b: >1- 4 cm
- pT3 R0: (up to 4cm only) with minimal extrathyroidal extension recommended by the MDT
• Willing to use contraception for the duration of the trial until 6 months post radioiodine treatment (for females) or 4 months post treatment (for males), if allocated to the ablation group.
N.B. Multifocal tumours (=2 foci) of all histological types should be designated with (m), and the size of the largest focus determines the classification (as described in the TNM 7th edition). For example, if there are two foci, one 0.8cm and the other 3cm, the classification is based on the 3cm focus; i.e. pT2(m).
• pT1a - Papillary and Follicular carcinoma which is unifocal and =1cm in size, without any positive nodes – or unfavourable clinical features, treated by lobectomy
• Up to 4cm non-invasive Encapsulated Follicular Variant of Papillary Thyroid Cancer (eFVPTC) with no capsular or vascular invasion (>4cm can be included at the discretion of the MDT)
• Non-invasive follicular tumour with papillary-like nuclei (NIFTP)
• Anaplastic, poorly differentiated or medullary carcinoma
• R1/R2 Thyroidectomy
• Patients with:
o pN1b
o M1
• Aggressive Papillary thyroid cancer with any of the following features:
o Widely invasive
o Poorly differentiated
o Anaplastic
o Tall cell
o Columnar cell
o Diffuse sclerosing variants
• Follicular thyroid cancer/Hürthle cell cancer with any of the following features:
o Tumours greater than 4cm
o Widely invasive
o Poorly differentiated
o Anaplastic
• pT4 and pT4b (TNM7) or pT3b, pT4a and pT4b (TNM8) or macroscopic and microscopic tumour invasion of loco-regional tissues or structures
• Women who are breast feeding
• Patients who have CT performed with iv contrast less than 2-3 months before ablation
• Previous treatment for thyroid cancer (except surgery in last 6 months)
• 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
• Dysphagia, oesophageal stricture, active gastritis, gastric erosions, peptic ulcer, suspected reduced gastrointestinal motility
• MDT decision against ablation or suitability for trial in light of severe co-morbid condition/s including:
o Unstable angina
o Recent myocardial infarction or cerebrovascular accident (CVA)
o Severe labile hypertension
o Any patient who cannot comply with radiation protection including:
- patients with learning difficulties
- patients with dementia
- patients with a tracheostomy that require nursing care
- patients requiring frequent nursing/ medical supervision
• pT3b (any size with gross extrathyroidal extension involving strap muscles) (TNM8)
• pN1a with level VII involvement (TNM8)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 5-year disease-free survival (histologically confirmed structural loco-regional recurrent or residual disease, distant recurrence)
- Secondary Outcome Measures
Name Time Method Cause Specific mortality;Loco-regional recurrence;Distant and biochemical recurrence;Interventions for recurrence;Additional investigations for recurrence;Quality of Life;Adverse events;Incidence of second primary tumours;Cost effectiveness