Actively Recruiting

Phase 3
Age: 18Years - 70Years
All Genders
NCT06082180

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

Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2023-10-13

1199

Participants Needed

1

Research Sites

234 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 to 70 years old with an ECOG score of 0-2
  • Thyroid nodule measuring 11-40 mm on ultrasound (cT1b-T2) with biopsy or intraoperative confirmation of papillary thyroid carcinoma
  • No suspicious lymph nodes on preoperative ultrasound (cN0) and no gross extrathyroidal extension
  • No serious medical diseases or major organ dysfunction
  • No history of other head and neck malignancies, neck radiation, or deep neck surgery except skin mass resection
  • Ability to understand and sign informed consent and comply with study visits
Not Eligible

You will not qualify if you...

  • History of other malignancies except curable non-melanoma skin cancer or cervical carcinoma in situ
  • Tumors larger than 40 mm (cT3) or smaller than or equal to 10 mm
  • Tumors with suspected or obvious extrathyroidal extension
  • Metastatic or suspicious neck lymph nodes (cN1)
  • No papillary thyroid carcinoma on biopsy or high-risk PTC subtype
  • Pregnant or breastfeeding women
  • Participation in another therapeutic clinical trial within four months prior to study entry

AI-Screening

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Trial Site Locations

Total: 1 location

1

Cancer Hospital, Chinese Academy of Medical Science

Beijing, Beijing Municipality, China, 100021

Actively Recruiting

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Research Team

J

jie liu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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