Thyroid Cancer
Conditions
Brief summary
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.
Interventions
PROCEDURELymph node tracer navigated selective neck dissection
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).
PROCEDUREModified neck dissection
Lymph nodes in compartment IIA, IIB, III, IV, VB are dissected.
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Pathologically confirmed PTC; * Age range: 14-80 years old; * Preoperative fine needle aspiration confirms lymph node metastasis in the lateral neck * Ultrasound and CT suggest that metastatic/suspected metastatic lymph nodes are limited to compartment IV, with 1-2 lymph node metastases and \<1cm in short diameter. The lymph nodes have no central necrosis, liquefaction, peripheral enhancement, or disappearance of adjacent fat spaces (predicting unobstructed lymphatic vessels); * Thyroid tumors without extra thyroidal extension; * Enough thyroid volume to inject tracer.
Exclusion criteria
* Previous neck surgery; * Bilateral neck lymph node dissection; * Distant metastases; * High risk pathological subtypes or the presence of other high-risk factors for recurrence; * Previous treatment for thyroid cancer other than endocrine therapy; * The patient is unable to cooperate with follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local-regional Recurrence Free Survival，LRFS | 5 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local-regional Recurrence Rate，LRR | 5 years | The percentage of patients with local-regional recurrence in the total number of patients. |
| Progression Free Survival，PFS | 5 years | The time from surgery to tumor progression, including local-regional recurrence and distant metastasis. |
| Overall Survival，OS | 5 years | The time from surgery to patient death |
| Adverse Events，AE | 5 years | The name of AE (based on NCI-CTCAE V5.0 criteria), severity, duration, and correlation with surgery. |
| Quality of Life as assessed by UW-QOL V4.1 | 5 years | 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). |
| Quality of Life as assessed by QoL/Thyroid | 5 years | 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. |
Countries
China
Contacts
CONTACTYu Wang, Dr.
Outcome results
None listed