Hemithyroidectomy or Total-Thyroidectomy in 'Low-risk' Thyroid Cancers
- Conditions
- Differentiated Thyroid Cancer
- Interventions
- Procedure: Total ThyroidectomyProcedure: Hemithyroidectomy
- Registration Number
- NCT05604963
- Lead Sponsor
- University College, London
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 456
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 2: Total Thyroidectomy Total Thyroidectomy Patients randomised to this arm will have a single TT operation to remove the entire thyroid gland. Group 2: Hemi-thyroidectomy Hemithyroidectomy Patients randomised to this arm will have a single HT operation to remove thyroid lobe with the tumour. Group 1: Two-stage Completion Thyroidectomy Total Thyroidectomy Patients randomised to this arm will undergo a 2nd operation to remove the remaining thyroid lobe.
- Primary Outcome Measures
Name Time Method 3 Year Recurrence Rate From surgery to any signs or symptoms of the cancer or death assessed up to a maximum of 3 years from surgery date (defined as thyroid cancer recurrence, metastatic disease or death from thyroid cancer (whichever occurs first))
- Secondary Outcome Measures
Name Time Method Anatomical Site of Recurrence From surgery to confirmed recurrence assessed up to a maximum of 5 years from surgery date Location of recurrence
Risk of Loco-Regional Recurrence From surgery to confirmed recurrence assessed up to a maximum of 5 years from surgery date (based on time to recurrence in the neck only)
Secondary Care Health Resource Use a. Baseline, 2-4 weeks and 6, 18, 30, 42, 54, 66 & 78 months from date of surgery. b. From surgery date to discharge, 2-4 weeks and 6, 18, 30, 42, 54, 66 & 78 months from date of surgery. c/d. 6, 18, 30, 42, 54, 66 & 78 months from date of surgery Collected using eCRFs and retrospectively for the study period from data in the Hospital Episodes Statistics linked to records in the NCRAS
Primary Care Health Resource Use a. Baseline, 2-4 weeks and 6, 18, 30, 42, 54, 66 & 78 months from date of surgery. b. From surgery date to discharge, 2-4 weeks and 6, 18, 30, 42, 54, 66 & 78 months from date of surgery. c/d. 6, 18, 30, 42, 54, 66 & 78 months from date of surgery Collected using eCRFs (Review of Primary Care Visits)
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 Number of further investigations/procedures related to the patient's thyroid surgery or thyroid cancer e.g. imaging, blood test, biopsy etc.
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 Type of further investigations/procedures related to the patient's thyroid surgery or thyroid cancer e.g. imaging, blood test, biopsy etc.
Voice Function Surgical complications and severity: From surgery date to discharge, 2-4 weeks, 6 months and 18 months from date of surgery; Voice Function: Post-randomisation/pre-surgery, 2-4 weeks and 6, 18, 30, 42, 54, 66 and 78 months from date of surgery. Measured using the Voice Handicap Index questionnaire (VHI-10); scores range from 0-40 with higher scores indicating greater voice-related handicap
Requirement for Hormone Replacement Therapy From surgery date to discharge, 2-4 weeks and 6, 18, 30, 42, 54, 66 and 78 months from date of surgery. (percentage of patients who require this therapy compared between the trial arms)
Surgical complications and severity Surgical complications and severity: From surgery date to discharge, 2-4 weeks, 6 months and 18 months from date of surgery; Voice Function: Post-randomisation/pre-surgery, 2-4 weeks and 6, 18, 30, 42, 54, 66 and 78 months from date of surgery. Using CTCAE v5.0 and the highest grade of each event type for each patient
Health Related Quality of Life Baseline (post-randomisation/pre-surgery), 2-4 weeks and 6, 18, 30, 42, 54, 66 and 78 months from date of surgery. Measured using FoP-Q-SF; scores range from 12-60 with higher scores indicating lower QoL and lower scores indicating higher QoL
Cost and Health Resource Use a. Baseline, 2-4 weeks and 6, 18, 30, 42, 54, 66 & 78 months from date of surgery. b. From surgery date to discharge, 2-4 weeks and 6, 18, 30, 42, 54, 66 & 78 months from date of surgery. c/d. 6, 18, 30, 42, 54, 66 & 78 months from date of surgery Measured using EORTC QLQ-THY34 (Cancer site specific QoL)
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 (defined as thyroid cancer recurrence, metastatic disease or death from thyroid cancer (whichever occurs first))
Trial Locations
- Locations (35)
Leighton Hospital
🇬🇧Crewe, Cheshire, United Kingdom
Glan Clwyd Hospital (Betsi Cadwaladr University Health Board)
🇬🇧Rhyl, United Kingdom
Aberdeen Royal Infirmary
🇬🇧Aberdeen, United Kingdom
Royal United Hospital
🇬🇧Bath, United Kingdom
Queen Elizabeth Hospital
🇬🇧Birmingham, United Kingdom
University Hospitals Bristol and Weston NHS Foundation Trust
🇬🇧Bristol, United Kingdom
Addenbrooke's Hospital
🇬🇧Cambridge, United Kingdom
University Hospital of Wales
🇬🇧Cardiff, United Kingdom
Colchester Hospital
🇬🇧Colchester, United Kingdom
Royal Derby Hospital
🇬🇧Derby, United Kingdom
Ninewells Hospital
🇬🇧Dundee, United Kingdom
NHS Lothian
🇬🇧Edinburgh, United Kingdom
Royal Devon and Exeter Hospital
🇬🇧Exeter, United Kingdom
Forth Valley Royal Hospital
🇬🇧Falkirk, United Kingdom
Medway Maritime Hospital
🇬🇧Gillingham, United Kingdom
NHS Greater Glasgow & Clyde
🇬🇧Glasgow, United Kingdom
Ipswich Hospital
🇬🇧Ipswich, United Kingdom
Leicester Royal Infirmary
🇬🇧Leicester, United Kingdom
Liverpool University Hospitals
🇬🇧Liverpool, United Kingdom
Guy's Hospital
🇬🇧London, United Kingdom
Lister Hospital
🇬🇧London, United Kingdom
Northwick Park Hospital
🇬🇧London, United Kingdom
St George's Hospital
🇬🇧London, United Kingdom
The Royal Marsden Hospitals
🇬🇧London, United Kingdom
University College London Hospital
🇬🇧London, United Kingdom
Luton and Dunstable University Hospital
🇬🇧Luton, United Kingdom
Northampton General Hospital
🇬🇧Northampton, United Kingdom
Norfolk and Norwich University Hospital
🇬🇧Norwich, United Kingdom
Nottingham University Hospitals NHS Trust
🇬🇧Nottingham, United Kingdom
Derriford Hospital
🇬🇧Plymouth, United Kingdom
University Hospitals Dorset NHS Foundation Trust
🇬🇧Poole, United Kingdom
Queen Alexandra Hospital
🇬🇧Portsmouth, United Kingdom
Royal Berkshire Hospital
🇬🇧Reading, United Kingdom
Sheffield Teaching Hospitals
🇬🇧Sheffield, United Kingdom
Musgrove Park Hospital
🇬🇧Taunton, United Kingdom