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This study is a phase III, randomized controlled, open label non inferiority study. Patients who meet the inclusion criteria are randomly assigned 1:1 to either the experimental group (selective neck dissection) or the control group (modified neck dissection), with LRFS as the primary endpoint. The aim of the study is to evaluate the safety of selective neck dissection in papillary carcinoma with limited number of lymph node metastases in the lateral neck, and the quality of life compared with modified neck dissection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Selective neck dissection | Experimental |
| |
| Modified neck dissection | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lymph node tracer navigated selective neck dissection | Procedure | Selective lateral lymph node dissection (after injection of tracer, lymph nodes in compartment III-IV are dissected; if there is dyed lymph node in compartment IIA, then IIA is dissected). |
| Measure | Description | Time Frame |
|---|---|---|
| Local-regional Recurrence Free Survival,LRFS | The time from surgery to the recurrence based on RECIST 1.1,. The definition of local-regional areas includes thyroid area, cervical I-VII lymph nodes, and retropharyngeal lymph nodes. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Local-regional Recurrence Rate,LRR | The percentage of patients with local-regional recurrence in the total number of patients. | 5 years |
| Progression Free Survival,PFS | The time from surgery to tumor progression, including local-regional recurrence and distant metastasis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu Wang, Dr. | Contact | 86-021-64175590 | 65805 | neck130@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan Univeristy Shanghai Cancer Center | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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| Modified neck dissection | Procedure | Lymph nodes in compartment IIA, IIB, III, IV, VB are dissected. |
|
| 5 years |
| Overall Survival,OS | The time from surgery to patient death | 5 years |
| Adverse Events,AE | The name of AE (based on NCI-CTCAE V5.0 criteria), severity, duration, and correlation with surgery. | 5 years |
| Quality of Life as assessed by UW-QOL V4.1 | Quality of life assessments will be conducted at 1 week, 3 months, 1 year, 2 years, and 5 years after surgery. The QoL evaluation scale adopts the Washington University Quality of Life Questionnaire V4.1 (UW-QOL V4.1). | 5 years |
| Quality of Life as assessed by QoL/Thyroid | Quality of life assessments will be conducted at 1 week, 3 months, 1 year, 2 years, and 5 years after surgery. The QoL evaluation scale adopts the Thyroid Cancer Quality of Life Scale QoL/Thyroid. | 5 years |
| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |