West China Hospital of Stomatology, Sichuan University
Chengdu, Sichuan, 610041, China
NCT Number: NCT07636499
The goal of this phase I clinical trial is to learn whether a multimodal follow-up evaluation combined with endoscopic selective neck dissection (ESND) is safe and feasible in patients with newly diagnosed N3 nasopharyngeal carcinoma.
The main questions it aims to answer are:
* Is the multimodal evaluation-guided surveillance-intervention approach safe for patients? * Is this approach feasible for identifying and managing residual cervical lymph nodes after radiotherapy? Participants will receive standard chemoradiotherapy. After treatment, they will undergo follow-up evaluation using clinical assessment, conventional imaging, Epstein-Barr virus DNA testing, and contrast-enhanced ultrasound. Participants with clinically suspicious residual cervical lymph nodes identified by multimodal evaluation and eligible for surgery underwent endoscopic selective neck dissection.
This study is active but is not currently recruiting participants.
Notify Me18 year–70 year
All sexes
Interventional
Phase 1
Chengdu, Sichuan, 610041, China
Patients with N3 nasopharyngeal carcinoma remain at risk of residual cervical lymph nodes after radiotherapy. Conventional imaging may have difficulty distinguishing viable residual tumor from post-radiotherapy edema, fibrosis, scarring, or inflammation. Contrast-enhanced ultrasound (CEUS) provides information on lymph node microvascular perfusion and may complement routine follow-up assessment. For patients with suspected residual cervical lymph nodes, neck dissection is an established salvage treatment option. Endoscopic selective neck dissection (ESND) is a minimally invasive surgical approach based on the principles of selective neck dissection and may reduce surgical trauma. This prospective, single-center, single-arm phase I study enrolled patients with pathologically confirmed N3 nasopharyngeal carcinoma. After completion of radiotherapy, participants underwent multimodal cervical lymph node follow-up evaluation, including clinical assessment, conventional imaging, Epstein-Barr virus DNA testing, and CEUS. During follow-up, participants with suspicious residual cervical lymph nodes identified by multimodal evaluation and suitable for surgery underwent ESND. Participants were followed for adverse events, postoperative complications, disease progression, locoregional recurrence, distant metastasis, and survival outcomes. The main purpose of this study is to evaluate the safety and feasibility of this multimodal evaluation-guided surveillance-intervention strategy.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
All participants underwent multimodal follow-up evaluation after radiotherapy. Endoscopic selective neck dissection was performed only in participants with suspicious residual cervical lymph nodes identified by multimodal evaluation and with surgical indications.
Time frame: From enrollment through post-radiotherapy follow-up, up to 36 months
Treatment-emergent adverse events are defined as adverse events occurring after the start of study intervention. Adverse events will be assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.
Time frame: From enrollment to completion of indicated endoscopic selective neck dissection or the end of follow-up, whichever occurs first, assessed up to 36 months after enrollment.
The completion rate is defined as the proportion of participants who undergo endoscopic selective neck dissection as planned among participants with suspected residual cervical nodal disease identified by multimodal evaluation.
Time frame: From enrollment to disease progression, death, or last follow-up, up to 36 months.
Progression-free survival is defined as the time from enrollment to disease progression, recurrence, distant metastasis, or death from any cause, whichever occurs first.
Time frame: From enrollment to distant metastasis, death, or last follow-up, up to 36 months.
Distant metastasis-free survival is defined as the time from enrollment to the first occurrence of distant metastasis or death from any cause, whichever occurs first.
Time frame: From enrollment to death or last follow-up, up to 36 months.
Overall survival is defined as the time from enrollment to death from any cause. Participants alive at the last follow-up will be censored.
Guiquan Zhu
Other
A Phase 1 Trial of Multimodal Evaluation-Guided Surveillance-Intervention With Endoscopic Selective Neck Dissection for N3 Nasopharyngeal Carcinoma After Radiotherapy
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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