Hemithyroidectomy or Total-Thyroidectomy in 'Low-risk' Thyroid Cancers

Not Applicable

Recruiting

• Conditions: Differentiated Thyroid Cancer

• 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

Study Timeline

• Study Start: 2022-02-14
• Study First Submitted: 2022-07-22
• Study First Submitted QC: 2022-10-31
• Study First Posted: 2022-11-03
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-11
• Primary Completion: 2028-07-31
• Study Completion: 2031-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 456

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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

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