Status:
RECRUITING
Hemithyroidectomy or Total-Thyroidectomy in 'Low-risk' Thyroid Cancers
Lead Sponsor:
University College, London
Collaborating Sponsors:
National Institute for Health Research, United Kingdom
Conditions:
Differentiated Thyroid Cancer
Eligibility:
All Genders
16+ years
Phase:
NA
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....
Eligibility Criteria
Inclusion
- 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
- \>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
Key Trial Info
Start Date :
February 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2031
Estimated Enrollment :
456 Patients enrolled
Trial Details
Trial ID
NCT05604963
Start Date
February 14 2022
End Date
July 31 2031
Last Update
March 5 2026
Active Locations (33)
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1
Leighton Hospital
Crewe, Cheshire, United Kingdom, CW1 4QJ
2
Royal United Hospital
Bath, United Kingdom
3
Queen Elizabeth Hospital
Birmingham, United Kingdom
4
University Hospitals Bristol and Weston NHS Foundation Trust
Bristol, United Kingdom