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

RecruitingPhase 3Ages 18 Years - 70 YearsAllCancer Institute and Hospital, Chinese Academy ofโ€ฆ
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In plain words

What the trial is, and whether it could suit you

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 makin

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: \- (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. Exclusion Criteria: -(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 โ‰ค 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
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What it tests

  • prophylactic central neck dissection
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Where

1 site
Cancer Hospital, Chinese Academy of Medical Science
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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