Nasopharyngeal CarcinomaPhase 3NCT05780372
Reduced Volume of Neck Prophylactic Irradiation in Nasopharyngeal Carcinoma
A Phase 3 study testing Intensity Modulated Radiation Therapy and Chemotherapy in people with Nasopharyngeal Carcinoma and Radiotherapy; Complications, run by Sun Yat-sen University at 7 sites in China.
Trial summary
This is a multi-center, non-inferiority, open-label, randomized controlled phase III clinical trial in primary diagnosed nasopharyngeal carcinoma (NPC) patients without distant metastasis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma, Radiotherapy; Complications
- What is being tested?
- Intensity Modulated Radiation Therapy and Chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 474 participants
- Where
- 7 sitesChina
- Study dates
- 8 Aug 2023to Apr 2028
- 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
- Newly histologic diagnosis of nasopharyngeal non-keratinizing carcinoma (WHO II/III);
- All genders, range from 18-70 years old;
- ECOG score 0-1;
- Clinical stage I-IVa (AJCC/UICC 8th);
- Not received radiotherapy, chemotherapy and other anti-tumor treatment (including immunotherapy);
- No contraindications to chemotherapy or radiotherapy;
- Adequate organ function: white blood cell count ≥ 4×109/L, neutrophile granulocyte count ≥ 1.5×109/L, hemoglobin ≥ 9g/L, platelet count ≥ 100×109/L; alanine aminotransferase or aspartate aminotransferase < 2.5×upper limit of normal; blood urea nitrogen or creatinine ≤ 1.5×upper limit of normal or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);
- Sign the consent form.
Who cannot join
- Neck lymph nodes exist skipping metastasis;
- Distant metastases;
- Keratinized squamous cell carcinoma or basal cell like squamous cell carcinoma;
- Have or are suffering from other malignant tumors;
- Participating in other clinical trials;
- Pregnancy or lactation;
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- Have uncontrolled cardiovascular disease;
- Severe complication, eg, uncontrolled hypertension;
- Mental disorder;
- Drug or alcohol addition;
- Do not have full capacity for civil acts.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality
Dongguan People Hospital
Dongguan, Guangdong
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
Liuzhou Worker's Hospital
Liuzhou, Guangxi
Jiangxi Cancer Hospital of Nanchang University
Nanchang, Jiangxi
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi
About this study
Official title: Reduced Volume of Neck Prophylactic Irradiation in Nasopharyngeal Carcinoma: a Multi-center, Non-inferiority, Open-label, Randomized Controlled Phase III Clinical Trial
This is a multi-center, non-inferiority, open-label, randomized controlled phase III clinical trial in primary diagnosed nasopharyngeal carcinoma (NPC) patients without distant metastasis. The purpose of this study is to evaluate the efficacy of reduced neck prophylactic radiotherapy versus conventional neck prophylactic radiotherapy, and compare the radiotherapy-related adverse events and quality of life in two groups.
- Being tested
- Intensity Modulated Radiation Therapy, Chemotherapy
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensity Modulated Radiation TherapyRadiation
Also called IMRT
All target volumes will be outlined slice by slice on the axial contrast-enhanced CT with MR fusion images in the treatment planning system. The target volumes are defined in accordance with the International Commission on Radiation Units and Measurements Reports 83. The prescribed dose is 70-72 Gy to PTVp (Planning target volume of the primary tumor), 64-70 Gy to PTVn (Planning target volume of the lymph node),60- 64Gy to PTV1 (High-risk planning target volume), and 54-58 Gy to PTV2 (Low-risk planning target volume) in 30-32 fractions. The details of dose limits for organs at risk are based on the study 0225 from The Radiation Therapy Oncology Group (RTOG 0225).
ChemotherapyDrug
Chemotherapy will be arranged by the physician-in-charge according to the NCCN guideline, patient's stage and physical condition.
| Study group | Role | What they receive |
|---|---|---|
| Reduced CTVn2 | Experimental | Patients will receive the reduced neck prophylactic irradiation, only the level of positive lymph nodes and its next level. Receives: Radiation: Intensity Modulated Radiation Therapy; Drug: Chemotherapy |
| Conventional CTVn2 | Active comparator | Patients will receive the conventional neck prophylactic irradiation, as suggested by the international guideline. Receives: Radiation: Intensity Modulated Radiation Therapy; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional recurrence-free survival
From the date of randomization to regional recurrence or any death
Measured: 3 years
Secondary outcomes (7)
Overall survival
From the date of randomization to any death, with patients unavailable for follow-up censored at the date of last follow-up
Measured: 3 years
Local recurrence-free survival
From the date of randomization to local recurrence or any death
Measured: 3 years
Distant metastasis-free survival
From the date of randomization to distant metastasis or any death
Measured: 3 years
Progression free survival
From the date of randomization to local or regional recurrence, distant metastasis or any death
Measured: 3 years
Acute toxicities
Assessed with CTCAE v5.0
Measured: From the start of treatment until 3 months post treatment
Late toxicities
Assessed with RTOG/EORTC
Measured: 3 years post treatment
Quality of life score
Assessed with EORTC-Quality of life questionnaire-C30 version 3.0
Measured: During treatment and 3 years post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2023
- Study start8 Aug 2023
- Primary completion1 Apr 2025
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangxi Provincial Cancer Hospital, Zhejiang Cancer Hospital, Chongqing University Cancer Hospital, Dongguan People's Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, First Affiliated Hospital of Guangxi Medical University, Liuzhou Workers' Hospital, The First Affiliated Hospital of Xiamen University, Wuzhou Red Cross Hospital, Hubei Cancer Hospital, First Hospital of China Medical University
- Responsible party
- Principal investigator, Zhao Chong, Sun Yat-sen University
- Investigators
- Chong Zhao, MD PhD, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05780372
- Sponsor's protocol ID
- Reduced CTV in NPC
- Status last verified
- May 2026
- First submitted
- 8 Mar 2023
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduced Volume of Neck Prophylactic Irradiation in Nasopharyngeal Carcinoma: a Multi-center, Non-inferiority, Open-label, Randomized Controlled Phase III Clinical Trial
- ClinicalTrials.gov ID
- NCT05780372
- Acronym / sponsor ID
- Reduced CTV in NPC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 474 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Jiangxi Provincial Cancer Hospital, Zhejiang Cancer Hospital, Chongqing University Cancer Hospital, Dongguan People's Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, First Affiliated Hospital of Guangxi Medical University, Liuzhou Workers' Hospital, The First Affiliated Hospital of Xiamen University, Wuzhou Red Cross Hospital, Hubei Cancer Hospital, First Hospital of China Medical University
- Study start
- 8 Aug 2023 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- Apr 2028 (estimated)
- First posted
- 22 Mar 2023 (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 multi-center, non-inferiority, open-label, randomized controlled phase III clinical trial in primary diagnosed nasopharyngeal carcinoma (NPC) patients without distant metastasis. The purpose of this study is to evaluate the efficacy of reduced neck prophylactic radiotherapy versus conventional neck prophylactic radiotherapy, and compare the radiotherapy-related adverse events and quality of life in two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reduced CTVn2 | Experimental | Radiation: Intensity Modulated Radiation Therapy, Drug: ChemotherapyPatients will receive the reduced neck prophylactic irradiation, only the level of positive lymph nodes and its next level. |
| Conventional CTVn2 | Active comparator | Radiation: Intensity Modulated Radiation Therapy, Drug: ChemotherapyPatients will receive the conventional neck prophylactic irradiation, as suggested by the international guideline. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Newly histologic diagnosis of nasopharyngeal non-keratinizing carcinoma (WHO II/III);
- All genders, range from 18-70 years old;
- ECOG score 0-1;
- Clinical stage I-IVa (AJCC/UICC 8th);
- Not received radiotherapy, chemotherapy and other anti-tumor treatment (including immunotherapy);
Key exclusion criteria (11 listed)
- Neck lymph nodes exist skipping metastasis;
- Distant metastases;
- Keratinized squamous cell carcinoma or basal cell like squamous cell carcinoma;
- Have or are suffering from other malignant tumors;
- Participating in other clinical trials;
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 |
|---|---|---|
| Intensity Modulated Radiation TherapyAlso: IMRTAll target volumes will be outlined slice by slice on the axial contrast-enhanced CT with MR fusion images in the treatment planning system. The target volumes are defined in accordance with the International Commission on Radiation Units and Measurements Reports 83. The prescribed dose is 70-72 Gy to PTVp (Planning target volume of the primary tumor), 64-70 Gy to PTVn (Planning target volume of the lymph node),60- 64Gy to PTV1 (High-risk planning target volume), and 54-58 Gy to PTV2 (Low-risk planning target volume) in 30-32 fractions. The details of dose limits for organs at risk are based on the study 0225 from The Radiation Therapy Oncology Group (RTOG 0225). | Radiation | Conventional CTVn2, Reduced CTVn2 |
| ChemotherapyChemotherapy will be arranged by the physician-in-charge according to the NCCN guideline, patient's stage and physical condition. | Drug | Conventional CTVn2, Reduced CTVn2 |
Primary outcome
Regional recurrence-free survival
Time frame: 3 years
From the date of randomization to regional recurrence or any death
7 secondary outcomes
Overall survival
Time frame: 3 years
Local recurrence-free survival
Time frame: 3 years
Distant metastasis-free survival
Time frame: 3 years
Progression free survival
Time frame: 3 years
Acute toxicities
Time frame: From the start of treatment until 3 months post treatment
Late toxicities
Time frame: 3 years post treatment
Quality of life score
Time frame: During treatment and 3 years post treatment
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 11 May 2026.
- Home Page of Cancer Center, Sun Yat-sen UniversityLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Chong Zhao, MD PhD principal investigator
Sun Yat-Sen University Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intensity Modulated Radiation Therapy and Chemotherapy in people with Nasopharyngeal Carcinoma and Radiotherapy; Complications, run by Sun Yat-sen University at 7 sites 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 8 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
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?
Regional recurrence-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 11 May 2026.