Comparing hemithyroidectomy and total thyroidectomy for low-risk thyroid cancers
Hemithyroidectomy or Total-Thyroidectomy in 'Low-risk' Thyroid Cancers
This study is testing whether a less extensive thyroid surgery is just as effective as a full thyroid removal for people with low-risk thyroid cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 456 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | University College, London Academic / other |
| Locations | 33 sites (Crewe, Cheshire and 32 other locations) |
| Trial ID | NCT05604963 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 16 or over diagnosed with low-risk differentiated thyroid cancer.
Not a fit: Patients with high-risk thyroid cancer or those who have not undergone prior hemithyroidectomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive surgical option for patients with low-risk thyroid cancer, potentially reducing complications and healthcare costs.
How similar studies have performed: Other studies have explored surgical options for thyroid cancer, but this specific comparison of hemithyroidectomy versus total thyroidectomy in low-risk cases is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Crewe, Cheshire and 32 other locations
- Leighton Hospital — Crewe, Cheshire, United Kingdom (Recruiting)
- Royal United Hospital — Bath, United Kingdom (Not_yet_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)
- Royal Derby Hospital — Derby, United Kingdom (Recruiting)
- Ninewells Hospital — Dundee, United Kingdom (Recruiting)
- NHS Lothian — Edinburgh, United Kingdom (Recruiting)
- Royal Devon and Exeter Hospital — Exeter, United Kingdom (Recruiting)
- Forth Valley Royal Hospital — Falkirk, United Kingdom (Recruiting)
- Medway Maritime Hospital — Gillingham, United Kingdom (Recruiting)
- NHS Greater Glasgow & Clyde — Glasgow, United Kingdom (Recruiting)
- Ipswich Hospital — Ipswich, United Kingdom (Recruiting)
- Leicester Royal Infirmary — Leicester, United Kingdom (Recruiting)
- Liverpool University Hospitals — Liverpool, United Kingdom (Recruiting)
- Guy's Hospital — London, United Kingdom (Recruiting)
- Lister Hospital — London, United Kingdom (Recruiting)
- Northwick Park Hospital — London, United Kingdom (Recruiting)
- St George's Hospital — London, United Kingdom (Recruiting)
- The Royal Marsden Hospitals — London, United Kingdom (Recruiting)
- University College London Hospital — London, United Kingdom (Not_yet_recruiting)
- Luton and Dunstable University Hospital — Luton, United Kingdom (Recruiting)
- Northampton General Hospital — Northampton, United Kingdom (Recruiting)
- Norfolk and Norwich University Hospital — Norwich, United Kingdom (Recruiting)
- Nottingham University Hospitals NHS Trust — Nottingham, United Kingdom (Not_yet_recruiting)
- Derriford Hospital — Plymouth, United Kingdom (Recruiting)
- University Hospitals Dorset NHS Foundation Trust — Poole, United Kingdom (Recruiting)
- Queen Alexandra Hospital — Portsmouth, United Kingdom (Recruiting)
- Glan Clwyd Hospital (Betsi Cadwaladr University Health Board) — Rhyl, United Kingdom (Recruiting)
- Sheffield Teaching Hospitals — Sheffield, United Kingdom (Recruiting)
- Musgrove Park Hospital — Taunton, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.