RecruitingPhase 3NCT06082180

A Prospective, Open-label, Multicenter, Randomized Controlled Phase III Study of Prophylactic Central Neck Dissection in Low-risk Papillary Thyroid Cancer


Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

1,199 participants

Start Date

Jul 1, 2022

Study Type

INTERVENTIONAL

Conditions

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 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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether surgically removing lymph nodes in the neck (called prophylactic central neck dissection) during thyroid cancer surgery improves outcomes for patients with low-risk papillary thyroid cancer — the most common and generally curable form of thyroid cancer. **You may be eligible if...** - You are between 18 and 70 years old - You have been diagnosed with papillary thyroid cancer confirmed by needle biopsy or surgical biopsy - Your thyroid tumor is between 11 and 40mm - There is no evidence of cancer spreading to nearby lymph nodes before surgery - You have good overall health with no major organ dysfunction **You may NOT be eligible if...** - You have cancer in another location (except treatable skin cancer or cervical cancer in situ) - Your tumor is larger than 40mm or shows signs of spreading beyond the thyroid - You have lymph nodes that look suspicious for cancer spread - You are pregnant or breastfeeding - You have participated in another clinical trial within 4 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREprophylactic central neck dissection

prophylactic central neck dissection was performed for the ipsilateral lesion


Locations(1)

Cancer Hospital, Chinese Academy of Medical Science

Beijing, Beijing Municipality, China

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NCT06082180


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