Prophylactic central neck dissection for low-risk papillary thyroid cancer
A Prospective, Open-label, Multicenter, Randomized Controlled Phase III Study of Prophylactic Central Neck Dissection in Low-risk Papillary Thyroid Cancer
This study is testing if a specific type of surgery can help people with low-risk thyroid cancer live longer and have fewer recurrences of the disease.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1199 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06082180 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of prophylactic central neck dissection in patients with low-risk papillary thyroid carcinoma (PTC). It aims to determine whether this surgical intervention can improve disease-specific survival and reduce local recurrence rates in patients with small thyroid nodules. The study involves a multicenter, randomized controlled design, focusing on patients aged 18-70 with specific eligibility criteria related to tumor size and absence of lymph node involvement. Participants will undergo surgery to assess the potential benefits of this approach in managing PTC.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with low-risk papillary thyroid carcinoma and no suspicious lymph nodes.
Not a fit: Patients with advanced thyroid cancer or those with a history of other head and neck malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved survival rates and reduced recurrence of thyroid cancer for patients with low-risk PTC.
How similar studies have performed: Previous studies have suggested potential benefits of prophylactic dissection in similar patient populations, indicating a promising avenue for further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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 ≤ 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
Where this trial is running
Beijing, Beijing Municipality
- Cancer Hospital, Chinese Academy of Medical Science — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: jie liu
- Email: liujie10-11@vip.163.com
- Phone: +861087787180
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.