Hemithyroidectomy or Total-Thyroidectomy in 'Low-risk' Thyroid Cancers (HoT)
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| ClinicalTrials.gov Identifier: NCT05604963 |
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Recruitment Status :
Recruiting
First Posted : November 3, 2022
Last Update Posted : November 29, 2023
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Sponsor:
University College, London
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
University College, London
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Differentiated Thyroid Cancer | Procedure: Total Thyroidectomy Procedure: Hemithyroidectomy | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 456 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Hemithyroidectomy or Total-Thyroidectomy in 'Low-risk' Thyroid Cancers |
| Actual Study Start Date : | February 14, 2022 |
| Estimated Primary Completion Date : | July 31, 2028 |
| Estimated Study Completion Date : | July 31, 2031 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Group 1: Two-stage Completion Thyroidectomy
Patients randomised to this arm will undergo a 2nd operation to remove the remaining thyroid lobe.
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Procedure: Total Thyroidectomy
Total Thyroidectomy - surgical removal of entire thyroid gland |
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No Intervention: Group 1: Surveillance
Patients randomised to this arm will have no 2nd surgery and proceed directly to follow-up visits.
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Experimental: Group 2: Hemi-thyroidectomy
Patients randomised to this arm will have a single HT operation to remove thyroid lobe with the tumour.
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Procedure: Hemithyroidectomy
Hemithyroidectomy - surgical removal of partial thyroid gland |
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Active Comparator: Group 2: Total Thyroidectomy
Patients randomised to this arm will have a single TT operation to remove the entire thyroid gland.
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Procedure: Total Thyroidectomy
Total Thyroidectomy - surgical removal of entire thyroid gland |
Primary Outcome Measures :
- 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 :
- 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))
- 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
- 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)
- 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.
- 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.
- 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
- 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
- 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)
- 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
- 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
- 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
- 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
- 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)
- 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)
- 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)
- 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
- 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)
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| Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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 NB. PTC is still eligible where microscopic invasion of endothelial lined small capillary vascular spaces and lymphatic channels are present. It becomes ineligible in the rare instances when there is definite invasion of a larger vascular structure such as a vein with smooth muscle in its wall.
- Encapsulated FVPTC with capsular invasion only
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Micro-PTC (≤1cm)
- multifocal
- unifocal with pN1a (≤5 foci; no extranodal spread)
Follicular thyroid cancer (FTC), including oncocytic or Hürthle cell carcinoma:
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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)
- NIFTP (non-invasive follicular thyroid neoplasm with papillary-like nuclear features)
- 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
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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
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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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05604963
Contacts
| Contact: Aniqa Tasnim (UCL Cancer Trials Centre) | 020 3108 4753 | ctc.hot@ucl.ac.uk |
Locations
Show 31 study locations
Sponsors and Collaborators
University College, London
National Institute for Health Research, United Kingdom
| Responsible Party: | University College, London |
| ClinicalTrials.gov Identifier: | NCT05604963 |
| Other Study ID Numbers: |
UCL/136591 |
| First Posted: | November 3, 2022 Key Record Dates |
| Last Update Posted: | November 29, 2023 |
| Last Verified: | November 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Thyroid Neoplasms Thyroid Diseases Endocrine System Diseases Endocrine Gland Neoplasms |
Neoplasms by Site Neoplasms Head and Neck Neoplasms |