Actively Recruiting
A Prospective, Open-label, Multicenter, Randomized Controlled 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
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the benefits and risks of prophylactic central lymph node dissection in patients with low-risk papillary thyroid carcinoma (PTC), specifically in those with primary tumors classified as cT1b-T2N0. PTC is the most common thyroid cancer, usually treated with surgery, but the need for removing lymph nodes that do not show obvious cancer involvement remains unclear. This study aims to clarify whether routine removal of these lymph nodes improves treatment response, reduces recurrence, and helps guide decisions about radioactive iodine therapy, while considering the risk of complications. The study randomly assigns participants to one of two groups: one group undergoes prophylactic central neck dissection on the side of the lesion, and the other group does not receive central neck dissection. Surgery is the primary intervention, and the trial is open-label and multicenter. The study includes adult patients aged 18 to 70 years with specific tumor sizes and no suspicious lymph nodes detected before surgery. Participants will be followed for at least one year to assess treatment response, measured by excellent response rates, and recurrence-free survival at one and two years. Assessments include monitoring thyroglobulin and its antibodies to evaluate short-term treatment outcomes. Study visits and follow-up tests will help track disease status and safety. The total participation duration is expected to cover these time points, supporting evaluation of long-term benefits and risks of the surgical approach.
CONDITIONS
Brief 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
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 70 years with ECOG score 0-2
- Thyroid nodule measuring 11-40 mm on ultrasound (cT1b-T2) confirmed as papillary thyroid carcinoma by biopsy or intraoperative frozen section
- No suspicious lymph nodes on preoperative ultrasound (cN0) and no gross extrathyroidal extension
- No serious medical diseases or dysfunction of major organs including blood, liver, kidney, heart, and lungs
- No history of other head and neck malignancies, neck radiation, or deep neck surgery except skin mass resection
- Able to understand, sign, and comply with study visits and procedures
You will not qualify if you...
- History of other malignancies except curable non-melanoma skin cancer and 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 on ultrasound or during surgery (cN1)
- No papillary thyroid carcinoma on biopsy or presence of high-risk PTC subtype
- Pregnant or breastfeeding women
- Participation in another therapeutic clinical trial within four months before study entry
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery plus immediate recovery period
Participants undergo surgery where some receive prophylactic central neck dissection while others do not.
1 surgery visit and several immediate post-operative visits
Duration - Up to 2 years
Participants are monitored for outcomes such as excellent response and recurrence-free survival.
Regular follow-up visits over 1 to 2 years
Trial Site Locations
Total: 1 location
1
Cancer Hospital, Chinese Academy of Medical Science
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
Research Team
J
jie liu
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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