Comparing hemithyroidectomy and total thyroidectomy for low-risk thyroid cancers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial is a multi-centre, randomised, non-inferiority study aimed at evaluating the effectiveness of hemithyroidectomy versus total thyroidectomy in patients with low-risk differentiated thyroid cancer. Patients will be divided into two groups: those who have previously undergone hemithyroidectomy and are diagnosed with low-risk cancer, and those diagnosed without prior surgery. Each group will be randomized to receive either surveillance or surgery, allowing researchers to assess the cost-effectiveness and outcomes of the two surgical approaches. The study aims to enroll a total of 456 patients to provide robust data on the best surgical option.

Why it matters

Who can join: the full rules

Group 1 (HT already performed prior to diagnosis)

Inclusion criteria

• Aged 16 or over

Papillary thyroid cancer:

* 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
* No higher risk histological variants on morphology (small foci allowed at the discretion of the local MDT)
* No angioinvasion NB. PTC is still eligible where microscopic invasion of endothelial lined small capillary vascular spaces and lymphatic channels are present. It becomes ineligible in the rare instances when there is definite invasion of a larger vascular structure such as a vein with smooth muscle in its wall.
* Encapsulated FVPTC with capsular invasion only
* Micro-PTC (≤1cm)

  * multifocal
  * unifocal with pN1a (≤5 foci; no extranodal spread)

Follicular thyroid cancer (FTC), including oncocytic or Hürthle cell carcinoma:

* pT1b-2 (≤4cm) irrespective of molecular genetic markers

  \- Minimally invasive, with capsular invasion +/- minimal (≤4 foci) vascular invasion (the latter is now called encapsulated angioinvasive and is at the discretion of the MDT)
* Confined to thyroid or minimal extrathyroidal extension

Exclusion criteria

* \>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
* R2
* gross extrathyroidal extension
* pT4 or macroscopic tumour invasion of loco-regional tissues or structures
* pN1a with \>5 foci or extranodal spread
* pN1b
* M1
* Aggressive PTC with any of the following features:

  * Widely invasive
  * Poorly differentiated
  * Anaplastic
  * predominance of Tall cell, Columnar cell, Hobnail, Diffuse sclerosing and other higher risk variants
* FTC, including oncocytic or Hürthle cell cancer with any of the following features:

  * Minimally invasive with extensive vascular invasion (now called encapsulated angioinvasive) (\>4 foci)
  * Widely invasive
  * Poorly differentiated
  * Anaplastic

Group 2 (DTC on cytology or after core biopsy, who has not had prior thyroid surgery yet)

Inclusion criteria

* Aged 16 or over
* 'low risk' differentiated thyroid cancer confirmed by cytology or core biopsy.
* cT1b-2 irrespective of molecular genetic markers
* cN0
* Contralateral lobe without suspicious nodule(s) (U2, or U3/U4 with Thy2 on FNAC)

Exclusion criteria

• M1

Where it's running

• Leighton Hospital
  Crewe, Cheshire, United Kingdom Recruiting
• Queen Elizabeth Hospital
  Birmingham, United Kingdom Recruiting
• University Hospitals Bristol and Weston NHS Foundation Trust
  Bristol, United Kingdom Recruiting
• Addenbrooke's Hospital
  Cambridge, United Kingdom Recruiting
• University Hospital of Wales
  Cardiff, United Kingdom Recruiting
• Colchester Hospital
  Colchester, United Kingdom Recruiting

Study contacts

• Principal investigator: Dae Kim — The Royal Marsden Hospital
• Study coordinator: Jeannie Chamberlain
• Email: ctc.hot@ucl.ac.uk
• Phone: 020 3108 4875

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.