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History of Changes for Study: NCT05604963
Hemithyroidectomy or Total-Thyroidectomy in 'Low-risk' Thyroid Cancers (HoT)
Latest version (submitted November 28, 2023) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 31, 2022 None (earliest Version on record)
2 November 28, 2023 Contacts/Locations, Study Status and Eligibility
Comparison Format:
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Study NCT05604963
Submitted Date:  October 31, 2022 (v1)
Open or close this module Study Identification
Unique Protocol ID: UCL/136591
Brief Title: Hemithyroidectomy or Total-Thyroidectomy in 'Low-risk' Thyroid Cancers (HoT)
Official Title: Hemithyroidectomy or Total-Thyroidectomy in 'Low-risk' Thyroid Cancers
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2022
Overall Status: Recruiting
Study Start: February 14, 2022
Primary Completion: July 31, 2028 [Anticipated]
Study Completion: July 31, 2031 [Anticipated]
First Submitted: July 22, 2022
First Submitted that
Met QC Criteria:		 October 31, 2022
First Posted: November 3, 2022 [Actual]
Last Update Submitted that
Met QC Criteria:		 October 31, 2022
Last Update Posted: November 3, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: University College, London
Responsible Party: Sponsor
Collaborators: National Institute for Health Research, United Kingdom
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Differentiated Thyroid Cancer
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 4
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 456 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Active Comparator: Group 1: Two-stage Completion Thyroidectomy
Patients randomised to this arm will undergo a 2nd operation to remove the remaining thyroid lobe.
 Procedure: Total Thyroidectomy
Total Thyroidectomy - surgical removal of entire thyroid gland
No Intervention: Group 1: Surveillance
Patients randomised to this arm will have no 2nd surgery and proceed directly to follow-up visits.
Experimental: Group 2: Hemi-thyroidectomy
Patients randomised to this arm will have a single HT operation to remove thyroid lobe with the tumour.
 Procedure: Hemithyroidectomy
Hemithyroidectomy - surgical removal of partial thyroid gland
Active Comparator: Group 2: Total Thyroidectomy
Patients randomised to this arm will have a single TT operation to remove the entire thyroid gland.
 Procedure: Total Thyroidectomy
Total Thyroidectomy - surgical removal of entire thyroid gland
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 3 Year Recurrence Rate
[ Time Frame: 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:
1. 5 Year Recurrence Rate
[ Time Frame: 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))
2. Anatomical Site of Recurrence
[ Time Frame: From surgery to confirmed recurrence assessed up to a maximum of 5 years from surgery date ]

Location of recurrence
3. Risk of Loco-Regional Recurrence
[ Time Frame: 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)
4. Number of Additional Investigations and Procedures after Surgery
[ Time Frame: 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.
5. Type of Additional Investigations and Procedures after Surgery
[ Time Frame: 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.
6. Voice Function
[ Time Frame: 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
7. Surgical complications and severity
[ Time Frame: 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
8. Requirement for Hormone Replacement Therapy
[ Time Frame: 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)
9. Health Related Quality of Life
[ Time Frame: Baseline (post-randomisation/pre-surgery), 2-4 weeks and 6, 18, 30, 42, 54, 66 and 78 months from date of surgery. ]

Measured using EORTC QLQ-C30; Scales range from 0-100 with higher scores for the functioning scales and global health status indicating higher QoL and higher scores on the symptom and single-item scales indicating lower QoL
10. Health Related Quality of Life
[ Time Frame: Baseline (post-randomisation/pre-surgery), 2-4 weeks and 6, 18, 30, 42, 54, 66 and 78 months from date of surgery. ]

Measured using EORTC QLQ-THY35; Scales range from 0-100 with higher scores indicating higher QoL and lower scores indicating lower QoL
11. Health Related Quality of Life
[ Time Frame: Baseline (post-randomisation/pre-surgery), 2-4 weeks and 6, 18, 30, 42, 54, 66 and 78 months from date of surgery. ]

Measured using EQ5D-5L; EQVAS score ranges from 0-100 with higher scores indicating higher QoL and lower scores indicating lower QoL; EQ-5D-5L index scores range from -0.224-1 with higher scores indicating higher QoL and lower scores indicating lower QoL
12. Health Related Quality of Life
[ Time Frame: 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
13. Cost and Health Resource Use
[ Time Frame: 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 EQ-5D-5L (generic QoL)
14. Cost and Health Resource Use
[ Time Frame: 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-C30 (cancer-specific QoL)
15. Cost and Health Resource Use
[ Time Frame: 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)
16. Secondary Care Health Resource Use
[ Time Frame: 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
17. Primary Care Health Resource Use
[ Time Frame: 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)
Open or close this module Eligibility
Minimum Age: 16 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
  • 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)
  • non-invasive encapsulated FVPTC
  • 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
Open or close this module Contacts/Locations
Central Contact Person: UCL Cancer Trials Centre
Telephone: 020 3108 4753
Email: ctc.hot@ucl.ac.uk
Locations: United Kingdom
Addenbrooke's Hospital
[Recruiting]
Cambridge, United Kingdom
Ninewells Hospital
[Recruiting]
Dundee, United Kingdom
NHS Lothian
[Recruiting]
Edinburgh, United Kingdom
NHS Greater Glasgow & Clyde
[Recruiting]
Glasgow, United Kingdom
Liverpool University Hospitals
[Recruiting]
Liverpool, United Kingdom
Lister Hospital
[Recruiting]
London, United Kingdom
Northwick Park Hospital
[Recruiting]
London, United Kingdom
St George's Hospital
[Recruiting]
London, United Kingdom
The Royal Marsden Hospitals
[Recruiting]
London, United Kingdom
Norfolk and Norwich University Hospital
[Recruiting]
Norwich, United Kingdom
Sheffield Teaching Hospitals
[Recruiting]
Sheffield, United Kingdom
Musgrove Park Hospital
[Recruiting]
Taunton, United Kingdom
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:
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