Hemithyroidectomy or Total-Thyroidectomy in 'Low-risk' Thyroid Cancers

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorUniversity College, London

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

456 Participants
are divided into 4 treatment groups

Sponsors and collaborators

University College, London

Lead sponsor

National Institute for Health Research, United Kingdom

Collaborator