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

NCT05604963 | Recruiting DMC

• 1 other identifier: UCL/136591
• Study Type: interventional
• Target: 456
• Locations: 1 country
• Sites: 33

Brief Summary

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.

Conditions

Differentiated Thyroid Cancer

Outcome Measures

Primary Outcomes (1)

• 3 Year Recurrence Rate

  (defined as thyroid cancer recurrence, metastatic disease or death from thyroid cancer (whichever occurs first))

  From surgery to any signs or symptoms of the cancer or death assessed up to a maximum of 3 years from surgery date

Secondary Outcomes (17)

• 5 Year Recurrence Rate

  From surgery to any signs or symptoms of the cancer or death assessed up to a maximum of 5 years from surgery date

• Anatomical Site of Recurrence

  From surgery to confirmed recurrence assessed up to a maximum of 5 years from surgery date

• Risk of Loco-Regional Recurrence

  From surgery to confirmed recurrence assessed up to a maximum of 5 years from surgery date

• Number of Additional Investigations and Procedures after Surgery

  2-4 weeks and 6, 18, 30, 42, 54, 66 and 78 months from date of surgery

• Type of Additional Investigations and Procedures after Surgery

  2-4 weeks and 6, 18, 30, 42, 54, 66 and 78 months from date of surgery

Study Arms (4)

Group 1: Two-stage Completion Thyroidectomy

ACTIVE COMPARATOR

Patients randomised to this arm will undergo a 2nd operation to remove the remaining thyroid lobe.

Procedure: Total Thyroidectomy

Group 1: Surveillance

NO INTERVENTION

Patients randomised to this arm will have no 2nd surgery and proceed directly to follow-up visits.

Group 2: Hemi-thyroidectomy

EXPERIMENTAL

Patients randomised to this arm will have a single HT operation to remove thyroid lobe with the tumour.

Procedure: Hemithyroidectomy

Group 2: Total Thyroidectomy

ACTIVE COMPARATOR

Patients randomised to this arm will have a single TT operation to remove the entire thyroid gland.

Procedure: Total Thyroidectomy

Interventions

Total Thyroidectomy PROCEDURE

Total Thyroidectomy - surgical removal of entire thyroid gland

Group 1: Two-stage Completion Thyroidectomy; Group 2: Total Thyroidectomy

Hemithyroidectomy PROCEDURE

Hemithyroidectomy - surgical removal of partial thyroid gland

Group 2: Hemi-thyroidectomy

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• \>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
• gross extrathyroidal extension
• pT4 or macroscopic tumour invasion of loco-regional tissues or structures
• pN1a with \>5 foci or extranodal spread
• pN1b
• 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)

Sponsors & Collaborators

• University College, London: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (33)

Leighton Hospital

Crewe, Cheshire, CW1 4QJ, 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 Officials

• Dae Kim

  The Royal Marsden Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeannie Chamberlain

CONTACT

020 3108 4875; ctc.hot@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: November 3, 2022
• Study Start: February 14, 2022
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2031
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (33)