Nasopharyngeal Cancinoma (NPC)NCT07692906
Multimodal Evaluation-Guided Surveillance-Intervention With Endoscopic Selective Neck Dissection for Post-Radiotherapy N3 Nasopharyngeal Carcinoma
A study testing Multimodal Evaluation-Guided Surveillance Strategy in people with Nasopharyngeal Cancinoma (NPC), run by Xuelei Ma MD.
Trial summary
This randomized trial evaluates a multimodal surveillance strategy in nasopharyngeal carcinoma patients with high-risk N3 cervical lymph node involvement after radiotherapy. Patients are assigned to standard follow-up or an enhanced strategy using CEUS, imaging, and EBV DNA for risk assessment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Cancinoma (NPC)
- What is being tested?
- Multimodal Evaluation-Guided Surveillance Strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 30 Jun 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 70 years.
- Pathologically confirmed nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated, i.e., WHO Type II or III).
- Tumor staged as TanyN3M0 according to the 9th Edition of the American Joint Committee on Cancer/Union for International Cancer Control (AJCC/UICC) staging system.
- ECOG performance status 0-1.
- No previous neck dissection.
- Adequate hematologic, hepatic, and renal function, defined as: white blood cell count ≥4.0 × 10^9/L, absolute neutrophil count ≥2.0 × 10^9/L, hemoglobin ≥90 g/L, platelet count ≥100 × 10^9/L, aspartate aminotransferase and alanine aminotransferase ≤2.5 × the upper limit of normal, and creatinine clearance ≥60 mL/min
- Written informed consent provided prior to study enrollment
Who cannot join
- Ongoing receipt of other antitumor treatment or concurrent participation in another interventional clinical trial.
- Pregnancy or breastfeeding.
- Severe concomitant disease that may, in the investigator's judgment, pose an unacceptable risk or compromise study compliance, including severe cardiac disease, severe pulmonary dysfunction, significant renal disease, or severe psychiatric illness.
- History of another invasive malignancy within 5 years before enrollment, except for adequately treated basal cell carcinoma of the skin, cervical carcinoma in situ, or superficial bladder tumors (Ta, Tis, or T1).
About this study
This randomized trial evaluates a multimodal surveillance strategy in nasopharyngeal carcinoma patients with high-risk N3 cervical lymph node involvement after radiotherapy. Patients are assigned to standard follow-up or an enhanced strategy using CEUS, imaging, and EBV DNA for risk assessment. The intervention group uses multimodal evaluation to identify high-risk patients who may undergo multidisciplinary review and selective neck dissection when indicated. The primary endpoint is failure-free survival (FFS). Secondary endpoints include OS, LRRFS, DMFS, and safety .
Read the detailed description
This is a multicenter, randomized controlled clinical trial evaluating a multimodal evaluation-guided surveillance and intervention strategy in patients with nasopharyngeal carcinoma (NPC) with high-risk N3-stage cervical lymph node involvement after radiotherapy. The study investigates whether combining contrast-enhanced ultrasound (CEUS), conventional imaging (CT/MRI), and Epstein-Barr virus (EBV) DNA monitoring can improve risk stratification, early detection of residual disease, and optimize subsequent treatment decision-making.
Eligible patients will be randomly assigned in a 1:1 ratio to receive either standard post-radiotherapy follow-up or a multimodal evaluation-guided surveillance and intervention strategy. In the control group, patients will receive standard follow-up care according to clinical guidelines. No CEUS or structured multimodal risk stratification will be applied in this group. In the intervention group, patients will undergo an enhanced follow-up strategy based on multimodal evaluation, which integrates CEUS, conventional imaging, and EBV DNA to stratify the risk of residual lymph node disease. Patients identified as high/ very high-risk may receive further multidisciplinary evaluation, and endoscopic selective neck dissection will be performed when indicated.
The primary endpoint is failure-free survival (FFS), defined as the time from randomization to the first occurrence of locoregional recurrence, distant metastasis, or death from any cause, whichever occurs first. Secondary endpoints include overall survival (OS), locoregional relapse-free survival (LRRFS), distant metastasis-free survival (DMFS), and treatment-related safety. Safety will be evaluated according to CTCAE version 5.0. A total of 80 patients will be enrolled across multiple centers in China.
- Conditions
- Nasopharyngeal Cancinoma (NPC)
- Being tested
- Multimodal Evaluation-Guided Surveillance Strategy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Evaluation-Guided Surveillance StrategyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Multimodal Evaluation-Guided Surveillance-Intervention Strategy | Experimental | Participants underwent multimodal follow-up evaluation after radiotherapy, including clinical assessment, conventional imaging, Epstein-Barr virus DNA testing, and contrast-enhanced ultrasound. Participants with suspicious residual cervical lymph nodes identified by multimodal evaluation and suitable for surgery underwent endoscopic selective neck dissection. Receives: Procedure: Multimodal Evaluation-Guided Surveillance Strategy |
| Standard follow-up strategy | No intervention | Patients will receive standard follow-up care according to clinical guidelines. No CEUS or structured multimodal risk stratification will be applied in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Failure-free Survival
Failure-free survival (FFS) is defined as the time from randomization to the first occurrence of locoregional recurrence, distant metastasis, or death from any cause, whichever occurs first.
Measured: From randomization to disease failure, death, or last follow-up, up to 60 months.
Secondary outcomes (4)
Overall Survival
Overall survival is defined as the time from randomization to death from any cause. Participants alive at the last follow-up will be censored.
Measured: From randomization to death or last follow-up, up to 60 months
Distant Metastasis-Free Survival
Distant metastasis-free survival is defined as the time from randomization to the first occurrence of distant metastasis or death from any cause, whichever occurs first.
Measured: From randomization to distant metastasis, death, or last follow-up, up to 60 months
Locoregional Relapse-free Survival
Locoregional relapse-free survival (LRRFS) is defined as the time from randomization to the first occurrence of locoregional recurrence or death from any cause, whichever occurs first.
Measured: From randomization to locoregional recurrence, death, or last follow-up, up to 60 months.
Incidence of Acute and Late Toxicity
Incidence of acute toxicity is calculated for each adverse event respectively and severity is evaluated on basis of Common Terminology Criteria for Adverse Events (CTCAE) 5.0 criteria. Late radiation toxicities were assessed using the Radiation Therapy Oncology Group and European Organization for Research and Treatment of Cancer late radiation morbidity scoring scheme.
Measured: From randomization to locoregional recurrence, death, or last follow-up, up to 60 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion30 Jun 2035 (estimated)
- Study completion30 Jun 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Cancinoma (NPC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuelei Ma MD
- Sponsor type
- University, hospital or other
- Collaborators
- West China Hospital of Stomatology, Sichuan Cancer Hospital and Research Institute, General Hospital of Western Theater Command, PLA, Yibin Second People's Hospital, Miyi County People's Hospital, Jintang First People's Hospital, Yilong County people's Hospital
- Responsible party
- Sponsor-investigator, Xuelei Ma MD, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07692906
- Sponsor's protocol ID
- 2026 (1385)
- Status last verified
- Jun 2026
- First submitted
- 3 Jul 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Evaluation-Guided Surveillance-Intervention With Endoscopic Selective Neck Dissection for Post-Radiotherapy N3 Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT07692906
- Acronym / sponsor ID
- 2026 (1385)
- Conditions
- Nasopharyngeal Cancinoma (NPC)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Xuelei Ma MDUniversity, hospital or other
- Collaborators
- West China Hospital of Stomatology, Sichuan Cancer Hospital and Research Institute, General Hospital of Western Theater Command, PLA, Yibin Second People's Hospital, Miyi County People's Hospital, Jintang First People's Hospital, Yilong County people's Hospital
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 30 Jun 2035 (estimated)
- Study completion
- 30 Jun 2035 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized trial evaluates a multimodal surveillance strategy in nasopharyngeal carcinoma patients with high-risk N3 cervical lymph node involvement after radiotherapy. Patients are assigned to standard follow-up or an enhanced strategy using CEUS, imaging, and EBV DNA for risk assessment. The intervention group uses multimodal evaluation to identify high-risk patients who may undergo multidisciplinary review and selective neck dissection when indicated. The primary endpoint is failure-free survival (FFS). Secondary endpoints include OS, LRRFS, DMFS, and safety .
Detailed description
This is a multicenter, randomized controlled clinical trial evaluating a multimodal evaluation-guided surveillance and intervention strategy in patients with nasopharyngeal carcinoma (NPC) with high-risk N3-stage cervical lymph node involvement after radiotherapy. The study investigates whether combining contrast-enhanced ultrasound (CEUS), conventional imaging (CT/MRI), and Epstein-Barr virus (EBV) DNA monitoring can improve risk stratification, early detection of residual disease, and optimize subsequent treatment decision-making.
Eligible patients will be randomly assigned in a 1:1 ratio to receive either standard post-radiotherapy follow-up or a multimodal evaluation-guided surveillance and intervention strategy. In the control group, patients will receive standard follow-up care according to clinical guidelines. No CEUS or structured multimodal risk stratification will be applied in this group. In the intervention group, patients will undergo an enhanced follow-up strategy based on multimodal evaluation, which integrates CEUS, conventional imaging, and EBV DNA to stratify the risk of residual lymph node disease. Patients identified as high/ very high-risk may receive further multidisciplinary evaluation, and endoscopic selective neck dissection will be performed when indicated.
The primary endpoint is failure-free survival (FFS), defined as the time from randomization to the first occurrence of locoregional recurrence, distant metastasis, or death from any cause, whichever occurs first. Secondary endpoints include overall survival (OS), locoregional relapse-free survival (LRRFS), distant metastasis-free survival (DMFS), and treatment-related safety. Safety will be evaluated according to CTCAE version 5.0. A total of 80 patients will be enrolled across multiple centers in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimodal Evaluation-Guided Surveillance-Intervention Strategy | Experimental | Procedure: Multimodal Evaluation-Guided Surveillance StrategyParticipants underwent multimodal follow-up evaluation after radiotherapy, including clinical assessment, conventional imaging, Epstein-Barr virus DNA testing, and contrast-enhanced ultrasound. Participants with suspicious residual cervical lymph nodes identified by multimodal evaluation and suitable for surgery underwent endoscopic selective neck dissection. |
| Standard follow-up strategy | No intervention | –Patients will receive standard follow-up care according to clinical guidelines. No CEUS or structured multimodal risk stratification will be applied in this group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18 to 70 years.
- Pathologically confirmed nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated, i.e., WHO Type II or III).
- Tumor staged as TanyN3M0 according to the 9th Edition of the American Joint Committee on Cancer/Union for International Cancer Control (AJCC/UICC) staging system.
- ECOG performance status 0-1.
- No previous neck dissection.
Key exclusion criteria (4 listed)
- Ongoing receipt of other antitumor treatment or concurrent participation in another interventional clinical trial.
- Pregnancy or breastfeeding.
- Severe concomitant disease that may, in the investigator's judgment, pose an unacceptable risk or compromise study compliance, including severe cardiac disease, severe pulmonary dysfunction, significant renal disease, or severe psychiatric illness.
- History of another invasive malignancy within 5 years before enrollment, except for adequately treated basal cell carcinoma of the skin, cervical carcinoma in situ, or superficial bladder tumors (Ta, Tis, or T1).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multimodal Evaluation-Guided Surveillance StrategyParticipants 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. | Procedure or surgery | Multimodal Evaluation-Guided Surveillance-Intervention Strategy |
Primary outcome
Failure-free Survival
Time frame: From randomization to disease failure, death, or last follow-up, up to 60 months.
Failure-free survival (FFS) is defined as the time from randomization to the first occurrence of locoregional recurrence, distant metastasis, or death from any cause, whichever occurs first.
4 secondary outcomes
Overall Survival
Time frame: From randomization to death or last follow-up, up to 60 months
Distant Metastasis-Free Survival
Time frame: From randomization to distant metastasis, death, or last follow-up, up to 60 months
Locoregional Relapse-free Survival
Time frame: From randomization to locoregional recurrence, death, or last follow-up, up to 60 months.
Incidence of Acute and Late Toxicity
Time frame: From randomization to locoregional recurrence, death, or last follow-up, up to 60 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Multimodal Evaluation-Guided Surveillance Strategy in people with Nasopharyngeal Cancinoma (NPC), run by Xuelei Ma MD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Failure-free Survival (time frame: From randomization to disease failure, death, or last follow-up, up to 60 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.