Trial Details

Trial status:

Active (recruiting)

Recruitment start date:

13/12/2021

Funder:

NIHR/HTA

Sponsor:

UCL

Chief Investigator:

Professor Dae Kim

Recruitment target:

456

EudraCT number:

Contact details:

ctc.hot@ucl.ac.uk

Note: For enquiries only. DO NOT use for clinical referrals.

HoT

Hemithyroidectomy or Total-Thyroidectomy in ‘low-risk’ thyroid cancers

Description

Design:

This is a multi-centre, randomised, non-inferiority, phase III surgical trial in patients with low risk differentiated thyroid cancer (DTC).

Treatment:

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 hemithyroidectomy for thyroid problems and are then subsequently diagnosed with low risk DTC will be randomised 1:1 to undergo surveillance (follow-up only) 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) or core biopsy but no surgery performed will be randomised 1:1 to have either a hemi-thyroidectomy OR a single-stage total thyroidectomy.

All thyroid surgeries performed on the trial will be as per the standard of care at the treating hospital.

Key inclusion/exclusion criteria:

Inclusion criteria for Group 1 (HT performed prior to diagnosis):

Low-risk thyroid cancer as defined by the American Thyroid Association 2015 and 8th AJCC TNM staging 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 for Group 1:

• >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

Inclusion criteria for Group 2:

• 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 for Group 2:

• M1

Eligibility criteria for nested sub-study on Navio’s web-based app (software)

Patients are eligible for the sub-study if they:

• have a SMS enabled mobile phone or handheld tablet with web access

• are able to use the web-based app to complete the trial questionnaires without assistance

Duration of recruitment: 456 patients will be recruited from ~30 UK hospitals over 48 months

Aim

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. This will be achieved by looking at:

3 year & 5 year recurrence rates
Anatomical site of recurrences
Risk of loco-regional recurrence
Number and type of additional investigations and procedures after surgery
Surgical complications and severity, including voice function
Requirement for hormone replacement therapy
Quality of life
Cost and health resource use

Contact the trial team

View trial documents

Cancer Research UK & UCL Cancer Trials Centre
University College London
90 Tottenham Court Road
London
W1T 4TJ

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Email:
ctc.enquiries@ucl.ac.uk
Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
Fax:
020 7679 9899

CTC staff

University College London, Gower Street, London, WC1E 6BT +44 (0)20 7679 2000