HoT – A phase III randomised trial to compare the rates of cancer returning in patients with low-risk differentiated thyroid cancer after a hemithyroidectomy and total thyroidectomy

Not Applicable

• Conditions: ow risk thyroid cancers; Cancer; Malignant neoplasm of thyroid gland

• Registration Number: ISRCTN17004671
• Lead Sponsor: niversity College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-02-22
• Last Update Posted: 20 November 2023
• Study Completion: 2028-07-31

Recruitment & Eligibility

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

Inclusion Criteria

Group 1 (Hemithyroidectomy already performed prior to diagnosis)
1. Aged 16 or over
2. Papillary thyroid cancer (PTC):
2.1. pT1b-2 (=4cm) irrespective of molecular genetic markers
2.2. R0 resection (clinically excised but microscopic R1 resected tumours at discretion of the local multidisciplinary team (MDT))
2.3. cN0 or pN0, pNX & pN1a (=5 foci, no extranodal spread)
2.4. Confined to thyroid or minimal extrathyroidal extension
2.5. No higher risk histological variants on morphology (small foci allowed at the discretion of the local MDT)
2.6. No angioinvasion
2.7. Encapsulated follicular variant of PTC with capsular invasion only
2.8. Micro-PTC (=1cm)
- multifocal
- unifocal with pN1a (=5 foci; no extranodal spread)
3. Follicular thyroid cancer and oncocytic/Hurthle cell carcinoma:
3.1. 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)
3.2. Confined to thyroid or minimal extrathyroidal extension

Group 2 (Differentiated Thyroid Cancer on cytology/core biopsy, who has not had prior thyroid surgery yet)
1. Aged 16 or over
2. ‘low risk’ differentiated thyroid cancer confirmed by cytology or core biopsy.
3. cT1b-2 irrespective of molecular genetic markers
4. cN0
5. Contralateral lobe without suspicious nodule(s) (U2, or U3/U4 with Thy2 on FNAC)

Eligibility criteria for nested sub-study on Navio’s web-based app (software):
1. Have a SMS enabled mobile phone or handheld tablet with web access
2. Are able to use the web-based app to complete the trial questionnaires without assistance

Exclusion Criteria

Group 1 (Hemithyroidectomy already performed prior to diagnosis):
1. Tumour > 4cm
2. Unifocal pT1a (< = 1cm) papillary thyroid cancer (PTC) and follicular thyroid cancer (FTC) (unless pN1a as listed in inclusion criteria)
3. Non-invasive encapsulated follicular variant of PTC
4. Anaplastic, poorly differentiated or medullary thyroid carcinoma
5. R2 resection
6. Gross extrathyroidal extension
7. pT4 or macroscopic tumour invasion of loco-regional tissues or structures
8. pN1a with > 5 foci or extranodal spread
9. pN1b
10. M1
11. 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
12. FTC and oncocytic/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 (Differentiated thyroid cancer on cytology or after core biopsy, who has not had prior thyroid surgery yet)
1. M1

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence rate at 3 years follow-up defined as thyroid cancer recurrence, metastatic disease or death from thyroid cancer (whichever occurs first), timed from date of surgery to 3 year follow up, analysed using Kaplan-Meier curves and Cox regression.