About this trial
This is a multi-centre, randomised, non-inferiority, phase III study in patients with low risk differentiated thyroid cancer.
Patients will be identified via oncology multidisciplinary team meetings. There will be two sources of patients in the trial, with the same histological diagnoses and prognosis (i.e. recurrence risk):
* Group 1: Patients who have already had a HT for thyroid problems and are then subsequently diagnosed with low risk DTC will be randomised 1:1 to undergo surveillance only OR a second operation to remove the rest of their thyroid gland (two-stage total thyroidectomy). * Group 2: Patients diagnosed with low risk DTC using cytology (Thy5) but no surgery performed will be randomised 1:1 to have either a hemi-thyroidectomy OR a single-stage total thyroidectomy.
The overall aim of the trial is to determine whether hemithyroidectomy is an acceptable and cost-effective surgical procedure compared to total thyroidectomy in low risk thyroid cancer. Overall, 456 patients will be recruited to the trial. Patients will be initially be followed up post-surgery then 12 monthly for 6 years.
Eligibility criteria
Qualifiers
pT1b-2 (≤4cm) irrespective of molecular genetic markers
R0 resection (clinically excised but microscopic R1 resected tumours at discretion of the local MDT)
cN0 or pN0, pNX & pN1a (≤5 foci, no extranodal spread)
Confined to thyroid or minimal extrathyroidal extension
Disqualifiers
>4cm
unifocal pT1a (≤1cm) PTC or FTC (unless pN1a as above)
NIFTP (non-invasive follicular thyroid neoplasm with papillary-like nuclear features)
Anaplastic, poorly differentiated or medullary thyroid carcinoma
Trial design
Treatments tested in this trial
- Total Thyroidectomy
- Hemithyroidectomy
Treatment groups
Sponsors and collaborators
University College, London
Lead sponsor
National Institute for Health Research, United Kingdom
Collaborator