Hemithyroidectomy or Total-Thyroidectomy in 'Low-risk' Thyroid Cancers (NCT05604963) | Clinical Trial Compass
RecruitingNot Applicable
Hemithyroidectomy or Total-Thyroidectomy in 'Low-risk' Thyroid Cancers
United Kingdom456 participantsStarted 2022-02-14
Plain-language 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.
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 fe…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
3 Year Recurrence Rate
Timeframe: From surgery to any signs or symptoms of the cancer or death assessed up to a maximum of 3 years from surgery date