Trial Title:
Hemithyroidectomy or Total-Thyroidectomy in 'Low-risk' Thyroid Cancers
NCT ID:
NCT05604963
Condition:
Differentiated Thyroid Cancer
Conditions: Official terms:
Thyroid Neoplasms
Thyroid Diseases
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Total Thyroidectomy
Description:
Total Thyroidectomy - surgical removal of entire thyroid gland
Arm group label:
Group 1: Two-stage Completion Thyroidectomy
Arm group label:
Group 2: Total Thyroidectomy
Intervention type:
Procedure
Intervention name:
Hemithyroidectomy
Description:
Hemithyroidectomy - surgical removal of partial thyroid gland
Arm group label:
Group 2: Hemi-thyroidectomy
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
16 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Aberdeen Royal Infirmary
Address:
City:
Aberdeen
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Sebastian Aspinall
Email:
Principal Investigator
Facility:
Name:
Royal United Hospital
Address:
City:
Bath
Country:
United Kingdom
Status:
Not yet recruiting
Investigator:
Last name:
Andrew Carswell
Email:
Principal Investigator
Facility:
Name:
Queen Elizabeth Hospital
Address:
City:
Birmingham
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Neil Sharma
Email:
Principal Investigator
Facility:
Name:
University Hospitals Bristol and Weston NHS Foundation Trust
Address:
City:
Bristol
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Oliver Dale
Email:
Principal Investigator
Facility:
Name:
Addenbrooke's Hospital
Address:
City:
Cambridge
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Brian Fish
Email:
Principal Investigator
Facility:
Name:
University Hospital of Wales
Address:
City:
Cardiff
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Michael Stechman
Email:
Principal Investigator
Facility:
Name:
Royal Derby Hospital
Address:
City:
Derby
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Hazem Nijim
Email:
Principal Investigator
Facility:
Name:
Ninewells Hospital
Address:
City:
Dundee
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Jaiganesh Manickavasagam
Email:
Principal Investigator
Facility:
Name:
NHS Lothian
Address:
City:
Edinburgh
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Iain Nixon
Email:
Principal Investigator
Facility:
Name:
Royal Devon and Exeter Hospital
Address:
City:
Exeter
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Joel Smith
Email:
Principal Investigator
Facility:
Name:
Forth Valley Royal Hospital
Address:
City:
Falkirk
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Michail Winkler
Email:
Principal Investigator
Facility:
Name:
NHS Greater Glasgow & Clyde
Address:
City:
Glasgow
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Catriona Douglas
Email:
Principal Investigator
Facility:
Name:
Ipswich Hospital
Address:
City:
Ipswich
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Billy Wong
Email:
Principal Investigator
Facility:
Name:
Medway Maritime Hospital
Address:
City:
Kent
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Maria Acosta
Email:
Principal Investigator
Facility:
Name:
Leicester Royal Infirmary
Address:
City:
Leicester
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Ram Vaidhyanath
Email:
Principal Investigator
Facility:
Name:
Liverpool University Hospitals
Address:
City:
Liverpool
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Christopher Loh
Email:
Principal Investigator
Facility:
Name:
Lister Hospital
Address:
City:
London
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
George Mochloulis
Email:
Principal Investigator
Facility:
Name:
Northwick Park Hospital
Address:
City:
London
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Zi Wei Liu
Email:
Principal Investigator
Facility:
Name:
St George's Hospital
Address:
City:
London
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Enyinnaya Ofo
Email:
Principal Investigator
Facility:
Name:
The Royal Marsden Hospitals
Address:
City:
London
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Vinidh Paleri
Email:
Principal Investigator
Facility:
Name:
University College London Hospital
Address:
City:
London
Country:
United Kingdom
Status:
Not yet recruiting
Investigator:
Last name:
Tarek Abdel-Aziz
Email:
Principal Investigator
Facility:
Name:
Luton and Dunstable University Hospital
Address:
City:
Luton
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Tarun Sood
Email:
Principal Investigator
Facility:
Name:
Northampton General Hospital
Address:
City:
Northampton
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Rohan Bidaye
Email:
Principal Investigator
Facility:
Name:
Norfolk and Norwich University Hospital
Address:
City:
Norwich
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Ramez Nassif
Email:
Principal Investigator
Facility:
Name:
Nottingham University Hospitals NHS Trust
Address:
City:
Nottingham
Country:
United Kingdom
Status:
Not yet recruiting
Investigator:
Last name:
Neeraj Sethi
Email:
Principal Investigator
Facility:
Name:
Derriford Hospital
Address:
City:
Plymouth
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Richard Williams
Email:
Principal Investigator
Facility:
Name:
University Hospitals Dorset NHS Foundation Trust
Address:
City:
Poole
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Neil De Zoysa
Email:
Principal Investigator
Facility:
Name:
Queen Alexandra Hospital
Address:
City:
Portsmouth
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Costa Repanos
Email:
Principal Investigator
Facility:
Name:
Royal Berkshire Hospital
Address:
City:
Reading
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Sidhartha Nagala
Email:
Principal Investigator
Facility:
Name:
Sheffield Teaching Hospitals
Address:
City:
Sheffield
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Saba Balasubramanian
Email:
Principal Investigator
Facility:
Name:
Musgrove Park Hospital
Address:
City:
Taunton
Country:
United Kingdom
Status:
Recruiting
Investigator:
Last name:
Edward Chisholm
Email:
Principal Investigator
Start date:
February 14, 2022
Completion date:
July 31, 2031
Lead sponsor:
Agency:
University College, London
Agency class:
Other
Collaborator:
Agency:
National Institute for Health Research, United Kingdom
Agency class:
Other
Source:
University College, London
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05604963
