Thyroid CancerPhase 3NCT06082180
A Prospective, Open-label, Multicenter, Randomized Controlled Phase III Study of Prophylactic Central Neck Dissection in Low-risk Papillary Thyroid Cancer
A Phase 3 study testing prophylactic central neck dissection in people with Thyroid Cancer and Recurrence, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
papillary thyroid carcinoma (PTC) is the most common thyroid cancer and has a good prognosis. Surgery is the primary treatment for PTC, and occult lymph node metastasis is not uncommon (20%-80%).The lymph node metastasis of PTC is mostly along the lymphatic drainage path station by station, and most of the first… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Thyroid Cancer, Recurrence
- What is being tested?
- prophylactic central neck dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,199 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 31 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (1)Patients age 18-70 years old, ECOG score 0-2; (2)Thyroid nodule measuring 11-40 mm on ultrasound (cT1bT2) and with fine-needle aspiration biopsy (FNAB) cytology in favor of "papillary thyroid carcinoma" or with intraoperative frozen section analysis "papillary thyroid carcinoma" .
- (3)cN0: absence of lymph nodes suspicious for malignancy on preoperative ultrasound performed by the center's designated radiologist according to a standardized report, no gross extrathyroidal extension was found before or during the surgery; (4)No serious medical disease and dysfunction of major organs, such as blood routine, liver, kidney, heart, and lung function; no previous history of other head and neck malignancies, no history of neck radiation, no history of deep neck surgery (skin mass resection except clinical); (5)Patients should understand, sign and date the written informed consent form prior to any protocol specific procedures. Patients should be able and willing to comply with study visits.
Who cannot join
- -(1)History of malignancy in other sites (previous or concurrent), excluding curable non-melanoma skin cancer and cervical carcinoma in situ; (2)Tumors > 40 mm (cT3) or ≤ 10 mm; tumors with extrathyroidal extension suspected or obvious on the pre-operative work-up or intra-operatively; (3)Metastatic neck lymph nodes or suspicious neck nodes on preoperative ultrasound (cN1); for suspicious nodes, FNAB cytology and thyroglobulin assay on the needle washout fluid will be performed.Metastatic neck lymph nodes found during the thyroidectomy and confirmed with intra-operative frozen section analysis.
- (4)No papillary thyroid carcinoma on FNAB cytology and/or high-risk subtype PTC; (5)Pregnant or breast feeding women (6)Participation in another therapeutic clinical trial within four months from study entry
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital, Chinese Academy of Medical Science
Beijing, Beijing Municipality, 100021
jie liu, MD, 8610-87787180
About this study
papillary thyroid carcinoma (PTC) is the most common thyroid cancer and has a good prognosis. Surgery is the primary treatment for PTC, and occult lymph node metastasis is not uncommon (20%-80%).The lymph node metastasis of PTC is mostly along the lymphatic drainage path station by station, and most of the first metastasis is to the central lymph node. According to the 2015 American Thyroid Association recommendation, prophylactic central lymph node dissection is recommended for patients with primary T3-4 or cN1b without central lymph node involvement. However, PTC with primary site T1-2, no external invasion and cN0 could not be dissected by central lymph node.Previous studies have suggested that prophylactic dissection should be performed to improve disease-specific survival, reduce local recurrence, improve recurrence risk and treatment response assessment, and help RAI decision making. Although routine prophylactic central lymph node dissection may detect occult lymph node metastasis, the need for further dissection of the recurrent laryngeal nerve and the parathyroid gland may lead to an increased incidence of complications, while its effect on reducing the risk of recurrence and improving prognosis is unclear, and the impact on long-term outcomes may be small.Previous retrospective studies in our institution have shown that routine central neck dissection does not significantly reduce the risk of recurrence. This study was designed to evaluate the benefits and risks of prophylactic central lymph node dissection in cT1b-T2N0 patients with papillary thyroid carcinoma. In order to ameliorate the effects of relapse and long time of death of PTC, thyroglobulin and its antibodies were also evaluated for short-term treatment response after surgery.
- Conditions
- Thyroid Cancer, Recurrence
- Being tested
- prophylactic central neck dissection
- Keywords
- Thyroid cancer, prophylactic central neck dissection, recurrence, thyroglobulin
- Medical subject headings
- Thyroid Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prophylactic central neck dissectionProcedure or surgery
prophylactic central neck dissection was performed for the ipsilateral lesion
| Study group | Role | What they receive |
|---|---|---|
| test group | Experimental | prophylactic central neck dissection Receives: Procedure: prophylactic central neck dissection |
| control group | No intervention | no central neck dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
excellent response
To assess the effect of prophylactic central neck dissection for excellent response of cN0 low-risk papillary thyroid cancer
Measured: 1 year
Secondary outcomes (1)
recurrence-free survival
to assess the influence of prophylactic central neck dissection on imporvement of RFS of cN0 low-risk papillary thyroid cancer
Measured: 1 year; 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start1 Jul 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- test group: prophylactic central neck dissction; control group: no central neck dissection
- Masking
- None (open label)
- Enrolment
- 1,199 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, liu jie, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06082180
- Sponsor's protocol ID
- CancerIHCAM
- Status last verified
- Oct 2023
- First submitted
- 8 Oct 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-label, Multicenter, Randomized Controlled Phase III Study of Prophylactic Central Neck Dissection in Low-risk Papillary Thyroid Cancer
- ClinicalTrials.gov ID
- NCT06082180
- Acronym / sponsor ID
- CancerIHCAM
- Conditions
- Thyroid Cancer, Recurrence
- Keywords
- Thyroid cancer, prophylactic central neck dissection, recurrence, thyroglobulin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,199 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
papillary thyroid carcinoma (PTC) is the most common thyroid cancer and has a good prognosis. Surgery is the primary treatment for PTC, and occult lymph node metastasis is not uncommon (20%-80%).The lymph node metastasis of PTC is mostly along the lymphatic drainage path station by station, and most of the first metastasis is to the central lymph node. According to the 2015 American Thyroid Association recommendation, prophylactic central lymph node dissection is recommended for patients with primary T3-4 or cN1b without central lymph node involvement. However, PTC with primary site T1-2, no external invasion and cN0 could not be dissected by central lymph node.Previous studies have suggested that prophylactic dissection should be performed to improve disease-specific survival, reduce local recurrence, improve recurrence risk and treatment response assessment, and help RAI decision making. Although routine prophylactic central lymph node dissection may detect occult lymph node metastasis, the need for further dissection of the recurrent laryngeal nerve and the parathyroid gland may lead to an increased incidence of complications, while its effect on reducing the risk of recurrence and improving prognosis is unclear, and the impact on long-term outcomes may be small.Previous retrospective studies in our institution have shown that routine central neck dissection does not significantly reduce the risk of recurrence. This study was designed to evaluate the benefits and risks of prophylactic central lymph node dissection in cT1b-T2N0 patients with papillary thyroid carcinoma. In order to ameliorate the effects of relapse and long time of death of PTC, thyroglobulin and its antibodies were also evaluated for short-term treatment response after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- test group: prophylactic central neck dissction; control group: no central neck dissection
| Arm | Type | Receives |
|---|---|---|
| test group | Experimental | Procedure: prophylactic central neck dissectionprophylactic central neck dissection |
| control group | No intervention | –no central neck dissection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- (1)Patients age 18-70 years old, ECOG score 0-2; (2)Thyroid nodule measuring 11-40 mm on ultrasound (cT1bT2) and with fine-needle aspiration biopsy (FNAB) cytology in favor of "papillary thyroid carcinoma" or with intraoperative frozen section analysis "papillary thyroid carcinoma" .
- (3)cN0: absence of lymph nodes suspicious for malignancy on preoperative ultrasound performed by the center's designated radiologist according to a standardized report, no gross extrathyroidal extension was found before or during the surgery; (4)No serious medical disease and dysfunction of major organs, such as blood routine, liver, kidney, heart, and lung function; no previous history of other head and neck malignancies, no history of neck radiation, no history of deep neck surgery (skin mass resection except clinical); (5)Patients should understand, sign and date the written informed consent form prior to any protocol specific procedures. Patients should be able and willing to comply with study visits.
Key exclusion criteria (2 listed)
- -(1)History of malignancy in other sites (previous or concurrent), excluding curable non-melanoma skin cancer and cervical carcinoma in situ; (2)Tumors > 40 mm (cT3) or ≤ 10 mm; tumors with extrathyroidal extension suspected or obvious on the pre-operative work-up or intra-operatively; (3)Metastatic neck lymph nodes or suspicious neck nodes on preoperative ultrasound (cN1); for suspicious nodes, FNAB cytology and thyroglobulin assay on the needle washout fluid will be performed.Metastatic neck lymph nodes found during the thyroidectomy and confirmed with intra-operative frozen section analysis.
- (4)No papillary thyroid carcinoma on FNAB cytology and/or high-risk subtype PTC; (5)Pregnant or breast feeding women (6)Participation in another therapeutic clinical trial within four months from study entry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prophylactic central neck dissectionprophylactic central neck dissection was performed for the ipsilateral lesion | Procedure or surgery | test group |
Primary outcome
excellent response
Time frame: 1 year
To assess the effect of prophylactic central neck dissection for excellent response of cN0 low-risk papillary thyroid cancer
1 secondary outcome
recurrence-free survival
Time frame: 1 year; 2 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing prophylactic central neck dissection in people with Thyroid Cancer and Recurrence, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact jie liu (+861087787180, liujie10-11@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
excellent response (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2023.