Nasopharyngeal Carcinoma by AJCC V9 StagePhase 3NCT07268690
Risk-Adapted Omission of Level Va Irradiation in Nasopharyngeal Carcinoma
A Phase 3 study testing Omission of Level Va Irradiation in Nasopharyngeal Carcinoma in people with Nasopharyngeal Carcinoma by AJCC V9 Stage, run by Fujian Cancer Hospital at 1 site in China.
Trial summary
This is a randomized, phase III, prospective, multi-center trial in newly diagnosed nasopharyngeal carcinoma (NPC) patients without distant metastasis. This study will evaluate whether omitting Level Va irradiation in patients without these risk features does not compromise regional control or survival, with the goal… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma by AJCC V9 Stage
- What is being tested?
- Omission of Level Va Irradiation in Nasopharyngeal Carcinoma
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 474 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 31 Dec 2030
- Phase
- Phase 3
- 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
- Pathologic diagnosis (pathologically confirmed by nasopharyngeal biopsy) was nasopharyngeal carcinoma;
- No distant metastatic;
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1;
- Signing informed consent;
- Follow up regularly and comply with test requirements.
Who cannot join
- Ipsilateral Level IIb involvement;
- Ipsilateral Level III nodes involvement;
- Ipsilateral positive lymph nodes below the cricoid cartilage (Level IV or Vb-c);
- Disease progression during IMRT;
- Previous malignancy or other concomitant malignant diseases;
- The evaluation information of tumor efficacy can not be obtained;
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- Receive blind treatment in other clinical research;
- Have or are suffering from other malignant tumors within 5 years (except non- melanoma skin cancer or pre-invasive cervical cancer);
- Serious complications, such as uncontrolled hypertension, coronary heart disease, diabetes, heart failure, etc;
- Active systemic infection;
- No or limited capacity for civil conduct;
- The patient has a physical or mental disorder, and the researcher considers that the patient is unable to fully or fully understand the possible complications of this study;
- Pregnancy or lactation period;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Risk-Adapted Omission of Level Va Irradiation in Nasopharyngeal Carcinoma: A Phase III Randomized Non-Inferiority Trial
This is a randomized, phase III, prospective, multi-center trial in newly diagnosed nasopharyngeal carcinoma (NPC) patients without distant metastasis. This study will evaluate whether omitting Level Va irradiation in patients without these risk features does not compromise regional control or survival, with the goal of providing robust evidence to guide further personalization of NPC radiotherapy.
- Being tested
- Omission of Level Va Irradiation in Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omission of Level Va Irradiation in Nasopharyngeal CarcinomaRadiation
Level Va should be irradiated only in the presence of any of the following high-risk features: 1. Ipsilateral Level IIb involvement; 2. Ipsilateral Level III nodes involvement; 3. Ipsilateral positive lymph nodes below the cricoid cartilage (Level IV or Vb-c).
| Study group | Role | What they receive |
|---|---|---|
| level Va-sparing IMRT | Experimental | Level Va irradiation is omitted except in the presence of any of the following high-risk features:
1. Ipsilateral Level IIb involvement;
2. Ipsilateral Level III nodes involvement;
3. Ipsilateral positive lymph nodes below the cricoid cartilage (Level IV or Vb-c); Receives: Radiation: Omission of Level Va Irradiation in Nasopharyngeal Carcinoma |
| level Va-covering IMRT | No intervention | Level Va is routinely irradiated according to CACA/CMDA guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional failure-free survival
The regional relapse-free survival rate will be estimated using Kaplan-Meier method for each arm from the date of randomization to the date of nodal relapse or death from any cause, whichever occurred first. Their differences will be compared between treatment arms using the log-rank test.
Measured: 3 years
Secondary outcomes (4)
overall survival
time from the date of the start of chemotherapy to death due to any cause
Measured: 3 years
Distant metastasis-free survival
The distant metastasis-free survival rate will be estimated using Kaplan-Meier
Measured: 3 years
Local failure-free survival
until documented treatment local failure or death from any cause.
Measured: 3 years
Patient's quality-of-life
European Organization for Research and Treatment of Cancer Quality-of-Life Head and Neck Questionnaire
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Carcinoma by AJCC V9 StageStudies of the same condition, open and under way.
- More trials run by Fujian Cancer HospitalThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 474 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Qiaojuan Guo, Study chair, Fujian Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07268690
- Sponsor's protocol ID
- NPC013
- Status last verified
- Nov 2025
- First submitted
- 23 Nov 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk-Adapted Omission of Level Va Irradiation in Nasopharyngeal Carcinoma: A Phase III Randomized Non-Inferiority Trial
- ClinicalTrials.gov ID
- NCT07268690
- Acronym / sponsor ID
- NPC013
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 474 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 8 Dec 2025 (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 is a randomized, phase III, prospective, multi-center trial in newly diagnosed nasopharyngeal carcinoma (NPC) patients without distant metastasis. This study will evaluate whether omitting Level Va irradiation in patients without these risk features does not compromise regional control or survival, with the goal of providing robust evidence to guide further personalization of NPC radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| level Va-sparing IMRT | Experimental | Radiation: Omission of Level Va Irradiation in Nasopharyngeal CarcinomaLevel Va irradiation is omitted except in the presence of any of the following high-risk features: 1. Ipsilateral Level IIb involvement; 2. Ipsilateral Level III nodes involvement; 3. Ipsilateral positive lymph nodes below the cricoid cartilage (Level IV or Vb-c); |
| level Va-covering IMRT | No intervention | –Level Va is routinely irradiated according to CACA/CMDA guidelines. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pathologic diagnosis (pathologically confirmed by nasopharyngeal biopsy) was nasopharyngeal carcinoma;
- No distant metastatic;
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1;
- Signing informed consent;
- Follow up regularly and comply with test requirements.
Key exclusion criteria (13 listed)
- Ipsilateral Level IIb involvement;
- Ipsilateral Level III nodes involvement;
- Ipsilateral positive lymph nodes below the cricoid cartilage (Level IV or Vb-c);
- Disease progression during IMRT;
- Previous malignancy or other concomitant malignant diseases;
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 |
|---|---|---|
| Omission of Level Va Irradiation in Nasopharyngeal CarcinomaLevel Va should be irradiated only in the presence of any of the following high-risk features: 1. Ipsilateral Level IIb involvement; 2. Ipsilateral Level III nodes involvement; 3. Ipsilateral positive lymph nodes below the cricoid cartilage (Level IV or Vb-c). | Radiation | level Va-sparing IMRT |
Primary outcome
Regional failure-free survival
Time frame: 3 years
The regional relapse-free survival rate will be estimated using Kaplan-Meier method for each arm from the date of randomization to the date of nodal relapse or death from any cause, whichever occurred first. Their differences will be compared between treatment arms using the log-rank test.
4 secondary outcomes
overall survival
Time frame: 3 years
Distant metastasis-free survival
Time frame: 3 years
Local failure-free survival
Time frame: 3 years
Patient's quality-of-life
Time frame: 3 years
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 8 Dec 2025.
- Individual participant dataSharing planned: No
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.
Qiaojuan Guo study chair
Fujian Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Omission of Level Va Irradiation in Nasopharyngeal Carcinoma in people with Nasopharyngeal Carcinoma by AJCC V9 Stage, run by Fujian Cancer Hospital at 1 site in China.
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 5 inclusion and 13 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 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Qiaojuan Guo (15080013157, guoqiaojuan163@.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional failure-free survival (time frame: 3 years). 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 8 Dec 2025.