Hemithyroidectomy or Total-Thyroidectomy in 'Low-risk' Thyroid Cancers
ConditionDifferentiated Thyroid Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorUniversity College, London
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
>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
Trial design
Design model
Parallel
Treatments tested in this trial
Total Thyroidectomy
Procedure/SurgeryTotal Thyroidectomy - surgical removal of entire thyroid gland
Hemithyroidectomy
Procedure/SurgeryHemithyroidectomy - surgical removal of partial thyroid gland
Treatment groups
456 Participants
are divided into 4 treatment groupsGroup A: Group 1: Two-stage Completion ThyroidectomyActive comparator 1 intervention
Group B: Group 1: SurveillanceNo intervention 0 interventions
Group C: Group 2: Hemi-thyroidectomyExperimental treatment 1 intervention
Group D: Group 2: Total ThyroidectomyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
3 Year Recurrence Rate
(defined as thyroid cancer recurrence, metastatic disease or death from thyroid cancer (whichever occurs first))
Time frame
From surgery to any signs or symptoms of the cancer or death assessed up to a maximum of 3 years from surgery dateSecondary outcomes
1
5 Year Recurrence Rate
(defined as thyroid cancer recurrence, metastatic disease or death from thyroid cancer (whichever occurs first))
Time frame
From surgery to any signs or symptoms of the cancer or death assessed up to a maximum of 5 years from surgery date2
Anatomical Site of Recurrence
Location of recurrence
Time frame
From surgery to confirmed recurrence assessed up to a maximum of 5 years from surgery date3
Risk of Loco-Regional Recurrence
(based on time to recurrence in the neck only)
Time frame
From surgery to confirmed recurrence assessed up to a maximum of 5 years from surgery date4
Number of Additional Investigations and Procedures after Surgery
Number of further investigations/procedures related to the patient's thyroid surgery or thyroid cancer e.g. imaging, blood test, biopsy etc.
Time frame
2-4 weeks and 6, 18, 30, 42, 54, 66 and 78 months from date of surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
University College, London
Lead sponsor
National Institute for Health Research, United Kingdom
Collaborator
Source ClinicalTrials.gov