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Hemithyroidectomy or Total-Thyroidectomy in 'Low-risk' Thyroid Cancers (HoT)

Primary Purpose

Differentiated Thyroid Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Total Thyroidectomy
Hemithyroidectomy
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Differentiated Thyroid Cancer

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Addenbrooke's HospitalRecruiting
  • Ninewells HospitalRecruiting
  • NHS LothianRecruiting
  • NHS Greater Glasgow & ClydeRecruiting
  • Liverpool University HospitalsRecruiting
  • Lister HospitalRecruiting
  • Northwick Park HospitalRecruiting
  • St George's HospitalRecruiting
  • The Royal Marsden HospitalsRecruiting
  • Norfolk and Norwich University HospitalRecruiting
  • Sheffield Teaching HospitalsRecruiting
  • Musgrove Park HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

No Intervention

Experimental

Active Comparator

Arm Label

Group 1: Two-stage Completion Thyroidectomy

Group 1: Surveillance

Group 2: Hemi-thyroidectomy

Group 2: Total Thyroidectomy

Arm Description

Patients randomised to this arm will undergo a 2nd operation to remove the remaining thyroid lobe.

Patients randomised to this arm will have no 2nd surgery and proceed directly to follow-up visits.

Patients randomised to this arm will have a single HT operation to remove thyroid lobe with the tumour.

Patients randomised to this arm will have a single TT operation to remove the entire thyroid gland.

Outcomes

Primary Outcome Measures

3 Year Recurrence Rate
(defined as thyroid cancer recurrence, metastatic disease or death from thyroid cancer (whichever occurs first))

Secondary Outcome Measures

5 Year Recurrence Rate
(defined as thyroid cancer recurrence, metastatic disease or death from thyroid cancer (whichever occurs first))
Anatomical Site of Recurrence
Location of recurrence
Risk of Loco-Regional Recurrence
(based on time to recurrence in the neck only)
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.
Type of Additional Investigations and Procedures after 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
Measured using the Voice Handicap Index questionnaire (VHI-10); scores range from 0-40 with higher scores indicating greater voice-related handicap
Surgical complications and severity
Using CTCAE v5.0 and the highest grade of each event type for each patient
Requirement for Hormone Replacement Therapy
(percentage of patients who require this therapy compared between the trial arms)
Health Related Quality of Life
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
Health Related Quality of Life
Measured using EORTC QLQ-THY35; Scales range from 0-100 with higher scores indicating higher QoL and lower scores indicating lower QoL
Health Related Quality of Life
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
Health Related Quality of Life
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
Measured using EQ-5D-5L (generic QoL)
Cost and Health Resource Use
Measured using EORTC QLQ-C30 (cancer-specific QoL)
Cost and Health Resource Use
Measured using EORTC QLQ-THY34 (Cancer site specific QoL)
Secondary Care Health Resource Use
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
Collected using eCRFs (Review of Primary Care Visits)

Full Information

First Posted
July 22, 2022
Last Updated
October 31, 2022
Sponsor
University College, London
Collaborators
National Institute for Health Research, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT05604963
Brief Title
Hemithyroidectomy or Total-Thyroidectomy in 'Low-risk' Thyroid Cancers
Acronym
HoT
Official Title
Hemithyroidectomy or Total-Thyroidectomy in 'Low-risk' Thyroid Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 14, 2022 (Actual)
Primary Completion Date
July 31, 2028 (Anticipated)
Study Completion Date
July 31, 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London
Collaborators
National Institute for Health Research, United Kingdom

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Differentiated Thyroid Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
456 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Two-stage Completion Thyroidectomy
Arm Type
Active Comparator
Arm Description
Patients randomised to this arm will undergo a 2nd operation to remove the remaining thyroid lobe.
Arm Title
Group 1: Surveillance
Arm Type
No Intervention
Arm Description
Patients randomised to this arm will have no 2nd surgery and proceed directly to follow-up visits.
Arm Title
Group 2: Hemi-thyroidectomy
Arm Type
Experimental
Arm Description
Patients randomised to this arm will have a single HT operation to remove thyroid lobe with the tumour.
Arm Title
Group 2: Total Thyroidectomy
Arm Type
Active Comparator
Arm Description
Patients randomised to this arm will have a single TT operation to remove the entire thyroid gland.
Intervention Type
Procedure
Intervention Name(s)
Total Thyroidectomy
Intervention Description
Total Thyroidectomy - surgical removal of entire thyroid gland
Intervention Type
Procedure
Intervention Name(s)
Hemithyroidectomy
Intervention Description
Hemithyroidectomy - surgical removal of partial thyroid gland
Primary Outcome Measure Information:
Title
3 Year Recurrence Rate
Description
(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 date
Secondary Outcome Measure Information:
Title
5 Year Recurrence Rate
Description
(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 date
Title
Anatomical Site of Recurrence
Description
Location of recurrence
Time Frame
From surgery to confirmed recurrence assessed up to a maximum of 5 years from surgery date
Title
Risk of Loco-Regional Recurrence
Description
(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 date
Title
Number of Additional Investigations and Procedures after Surgery
Description
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 surgery
Title
Type of Additional Investigations and Procedures after Surgery
Description
Type 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 surgery
Title
Voice Function
Description
Measured using the Voice Handicap Index questionnaire (VHI-10); scores range from 0-40 with higher scores indicating greater voice-related handicap
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.
Title
Surgical complications and severity
Description
Using CTCAE v5.0 and the highest grade of each event type for each patient
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.
Title
Requirement for Hormone Replacement Therapy
Description
(percentage of patients who require this therapy compared between the trial arms)
Time Frame
From surgery date to discharge, 2-4 weeks and 6, 18, 30, 42, 54, 66 and 78 months from date of surgery.
Title
Health Related Quality of Life
Description
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
Time Frame
Baseline (post-randomisation/pre-surgery), 2-4 weeks and 6, 18, 30, 42, 54, 66 and 78 months from date of surgery.
Title
Health Related Quality of Life
Description
Measured using EORTC QLQ-THY35; Scales range from 0-100 with higher scores indicating higher QoL and lower scores indicating lower QoL
Time Frame
Baseline (post-randomisation/pre-surgery), 2-4 weeks and 6, 18, 30, 42, 54, 66 and 78 months from date of surgery.
Title
Health Related Quality of Life
Description
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
Time Frame
Baseline (post-randomisation/pre-surgery), 2-4 weeks and 6, 18, 30, 42, 54, 66 and 78 months from date of surgery.
Title
Health Related Quality of Life
Description
Measured using FoP-Q-SF; scores range from 12-60 with higher scores indicating lower QoL and lower scores indicating higher QoL
Time Frame
Baseline (post-randomisation/pre-surgery), 2-4 weeks and 6, 18, 30, 42, 54, 66 and 78 months from date of surgery.
Title
Cost and Health Resource Use
Description
Measured using EQ-5D-5L (generic QoL)
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
Title
Cost and Health Resource Use
Description
Measured using EORTC QLQ-C30 (cancer-specific QoL)
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
Title
Cost and Health Resource Use
Description
Measured using EORTC QLQ-THY34 (Cancer site specific QoL)
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
Title
Secondary Care Health Resource Use
Description
Collected using eCRFs and retrospectively for the study period from data in the Hospital Episodes Statistics linked to records in the NCRAS
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
Title
Primary Care Health Resource Use
Description
Collected using eCRFs (Review of Primary Care Visits)
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
UCL Cancer Trials Centre
Phone
020 3108 4753
Email
ctc.hot@ucl.ac.uk
Facility Information:
Facility Name
Addenbrooke's Hospital
City
Cambridge
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Ninewells Hospital
City
Dundee
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
NHS Lothian
City
Edinburgh
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
NHS Greater Glasgow & Clyde
City
Glasgow
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Liverpool University Hospitals
City
Liverpool
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Lister Hospital
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Northwick Park Hospital
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
St George's Hospital
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
The Royal Marsden Hospitals
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Norfolk and Norwich University Hospital
City
Norwich
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Sheffield Teaching Hospitals
City
Sheffield
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Musgrove Park Hospital
City
Taunton
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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

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