Nasopharyngeal Cancinoma (NPC)Phase 3NCT07072000
Shrinking the Anterior Border of CTV2 for Nasopharyngeal Carcinoma to Reduce the Radiation of Nasal Cavity
A Phase 3 study testing standard CTV delineation and reduced CTV delineation in people with Nasopharyngeal Cancinoma (NPC), run by Hai-Qiang Mai,MD,PhD at 5 sites in China.
Trial summary
This is a an open-label, non-inferiority, multicenter, randomized phase III trial aimed to explore the efficacy and safety of shrinking the anterior border of CTV2 in nasopharyngeal carcinoma patients without tumor invasion into the posterior nasal aperture. 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?
- standard CTV delineation and reduced CTV delineation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 5 sitesChina
- Study dates
- 1 Aug 2025to 31 Jul 2032
- 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 diagnosed, histologically confirmed non-keratinizing carcinoma (WHO classification).
- Stage I-III disease (AJCC 9th edition).
- Tumor extends to nasal cavity (including nasal septum).
- No distant metastasis (M0).
- Age 18-70 years.
- Male or non-pregnant female.
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- Scheduled for radiotherapy.
- ECOG performance status 0-1 .
- Adequate bone marrow function: white blood cells >4×10⁹/L, hemoglobin >90 g/L, platelets >100×10⁹/L.
- Normal hepatic/renal function: total bilirubin ≤1.5×ULN, AST/ALT ≤2.5×ULN, alkaline phosphatase ≤2.5×ULN, creatinine clearance ≥60 mL/min.
- Written informed consent obtained.
Who cannot join
- Keratinizing squamous cell carcinoma (WHO Type I) or basaloid squamous cell carcinoma.
- Age <18 or >70 years.
- Recurrent disease or distant metastasis.
- No tumor extension into the nasal cavity (including the nasal septum).
- Prior malignancy (except adequately treated basal/squamous cell skin cancer or cervical carcinoma in situ).
- Pregnancy/lactation (premenopausal women require pregnancy test; effective contraception mandated).
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- Prior radiotherapy (except non-melanoma skin cancer with lesions outside current portals).
- Preoperative chemotherapy or surgical resection of primary/neck lesions (excluding diagnostic procedures).
- Severe coexisting illness.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites
First People's Hospital of Foshan
Foshan, Guangdong
Ning Zhang, +86075783833633, zning@fsyyy.com
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Qiu-yan Chen, Dr., +8602087343380, chenqy@sysucc.org.cn
Qiu-Yan Chen, Dr., chenqy@sysucc.org.cn
The Fourth Affiliated Hospital of Guangxi Medical University
Liuzhou, Guangxi
Ying Lu, +8607723111580
Wuzhou Red Cross Hospital
Wuzhou, Guangxi
Jinhui Liang, +8607745812345, 566jv@sina.cn
Affiliated Hospital of Guangdong Medical University
Zhangjiang, Guangdong
Haiqing Luo, +8607592369336, hqluo@126.com
About this study
Official title: Shrinking the Anterior Border of CTV2 for Nasopharyngeal Carcinoma to Reduce the Radiation of Nasal Cavity : an Open-label, Non-inferiority, Multicenter, Randomized Phase III Trial
This is a an open-label, non-inferiority, multicenter, randomized phase III trial aimed to explore the efficacy and safety of shrinking the anterior border of CTV2 in nasopharyngeal carcinoma patients without tumor invasion into the posterior nasal aperture.
Read the detailed description
This is a an open-label, non-inferiority, multicenter, randomized phase III trial aimed to explore the efficacy and safety of shrinking the anterior border of CTV2 in nasopharyngeal carcinoma patients without tumor invasion into the posterior nasal aperture. The enrolled patients will be 1:1 randomly assigned to receive reduced CTV delineation radiotherapy (anterior border of CTV2 defined as 5 mm anterior to the choanae), or standard CTV delineation radiotherapy (anterior border of CTV2 defined as the posterior 1/3 of the nasal cavity).
- Conditions
- Nasopharyngeal Cancinoma (NPC)
- Being tested
- standard CTV delineation, reduced CTV delineation
- Keywords
- nasopharyngeal carcinoma, radiotherapy
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard CTV delineationRadiation
The anterior border of CTV2 is delineated at the posterior 1/3 of the nasal cavity.
reduced CTV delineationRadiation
The anterior border of CTV2 is defined as 5 mm anterior to the posterior nasal cavity anteriorly from the choanae.
| Study group | Role | What they receive |
|---|---|---|
| Reduced delineation arm | Experimental | Not described Receives: Radiation: reduced CTV delineation |
| Standard delineation arm | Active comparator | Not described Receives: Radiation: standard CTV delineation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local relapse-free survival
The time from randomization to documented local relapse or death from any cause.
Measured: 3 year
Secondary outcomes (6)
Overall survival
The time from randomization to death from any cause or censored at the date of the last follow-up.
Measured: 3 year
Progression-free survival
The time from randomization to any documented local or regional relapse, distant metastasis, or death from any cause, whichever occur first.
Measured: 3 year
Distant metastasis-free survival
The time from randomization to distant metastasis or death from any cause.
Measured: 3 year
Regional relapse-free survival
The time from randomization to documented regional relapse or death from any cause.
Measured: 3 year
Incidence rate of adverse events (AEs)
Analysis of acute and late adverse events (AEs) are evaluated. Numbers of patients of treatment-related adverse events(acute toxicity) as assessed by CTCAE v5.0.Numbers of patients of 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: 2 year
Change of quality of life
Quality of life scores were assessed for each scale by using the 22-item Sino-Nasal Outcome Test (SNOT-22) before radiotherapy, at the end of radiotherapy, and at the 3, 6, 12 month after radiotherapy.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start1 Aug 2025 (estimated)
- Primary completion31 Jul 2030 (estimated)
- Study completion31 Jul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hai-Qiang Mai,MD,PhD
- Sponsor type
- University, hospital or other
- Collaborators
- First People's Hospital of Foshan, Affiliated Hospital of Guangdong Medical University, The Wuzhou Red Cross Hospital, Fourth Affiliated Hospital of Guangxi Medical University, Zhongshan City People 's Hospital
- Responsible party
- Sponsor-investigator, Hai-Qiang Mai,MD,PhD, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07072000
- Sponsor's protocol ID
- 2024-FXY-483
- Status last verified
- Jul 2025
- First submitted
- 16 Jul 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Mao YP, Wang SX, Gao TS, Zhang N, Liang XY, Xie FY, Zhang Y, Zhou GQ, Guo R, Luo WJ, Li YJ, Liang SQ, Lin L, Li WF, Liu X, Xu C, Chen YP, Lv JW, Huang SH, Liu LZ, Li JB, Tang LL, Chen L, Sun Y, Ma J. Medial retropharyngeal nodal region sparing radiotherapy versus standard radiotherapy in patients with nasopharyngeal carcinoma: open label, non-inferiority, multicentre, randomised, phase 3 trial. BMJ. 2023 Feb 6;380:e072133. doi: 10.1136/bmj-2022-072133.
PubMed 36746459Sanford NN, Lau J, Lam MB, Juliano AF, Adams JA, Goldberg SI, Lu HM, Lu YC, Liebsch NJ, Curtin HD, Chan AW. Individualization of Clinical Target Volume Delineation Based on Stepwise Spread of Nasopharyngeal Carcinoma: Outcome of More Than a Decade of Clinical Experience. Int J Radiat Oncol Biol Phys. 2019 Mar 1;103(3):654-668. doi: 10.1016/j.ijrobp.2018.10.006. Epub 2018 Oct 15.
PubMed 30712708Lin SJ, Guo QJ, Liu Q, Ng WT, Ahn YC, AlHussain H, Chan AW, Chow J, Chua MLK, Corry J, Han F, Gregoire V, Harrington KJ, Hu CS, Jensen K, Langendijk JA, Le QT, Lee NY, Lee V, Lin JC, Ma J, Mendenhall WM, O'Sullivan B, Ozyar E, Rosenthal DI, Tao YG, Wang RS, Wee J, Xu ZY, Yi JL, Yom SS, Fan DM, Mai HQ, Pan JJ, Lee AWM. International Consensus Guideline on Delineation of the Clinical Target Volumes at Different Dose Levels for Nasopharyngeal Carcinoma (2024 Version). Int J Radiat Oncol Biol Phys. 2025 Oct 1;123(2):415-431. doi: 10.1016/j.ijrobp.2025.05.019. Epub 2025 May 24.
PubMed 40419028Lee NY, Zhang Q, Pfister DG, Kim J, Garden AS, Mechalakos J, Hu K, Le QT, Colevas AD, Glisson BS, Chan AT, Ang KK. Addition of bevacizumab to standard chemoradiation for locoregionally advanced nasopharyngeal carcinoma (RTOG 0615): a phase 2 multi-institutional trial. Lancet Oncol. 2012 Feb;13(2):172-80. doi: 10.1016/S1470-2045(11)70303-5. Epub 2011 Dec 15.
PubMed 22178121Liang SB, Sun Y, Liu LZ, Chen Y, Chen L, Mao YP, Tang LL, Tian L, Lin AH, Liu MZ, Li L, Ma J. Extension of local disease in nasopharyngeal carcinoma detected by magnetic resonance imaging: improvement of clinical target volume delineation. Int J Radiat Oncol Biol Phys. 2009 Nov 1;75(3):742-50. doi: 10.1016/j.ijrobp.2008.11.053. Epub 2009 Feb 27.
PubMed 19251378
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shrinking the Anterior Border of CTV2 for Nasopharyngeal Carcinoma to Reduce the Radiation of Nasal Cavity : an Open-label, Non-inferiority, Multicenter, Randomized Phase III Trial
- ClinicalTrials.gov ID
- NCT07072000
- Acronym / sponsor ID
- 2024-FXY-483
- Conditions
- Nasopharyngeal Cancinoma (NPC)
- Keywords
- nasopharyngeal carcinoma, radiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Hai-Qiang Mai,MD,PhDUniversity, hospital or other
- Collaborators
- First People's Hospital of Foshan, Affiliated Hospital of Guangdong Medical University, The Wuzhou Red Cross Hospital, Fourth Affiliated Hospital of Guangxi Medical University, Zhongshan City People 's Hospital
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 31 Jul 2030 (estimated)
- Study completion
- 31 Jul 2032 (estimated)
- First posted
- 18 Jul 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 an open-label, non-inferiority, multicenter, randomized phase III trial aimed to explore the efficacy and safety of shrinking the anterior border of CTV2 in nasopharyngeal carcinoma patients without tumor invasion into the posterior nasal aperture.
Detailed description
This is a an open-label, non-inferiority, multicenter, randomized phase III trial aimed to explore the efficacy and safety of shrinking the anterior border of CTV2 in nasopharyngeal carcinoma patients without tumor invasion into the posterior nasal aperture. The enrolled patients will be 1:1 randomly assigned to receive reduced CTV delineation radiotherapy (anterior border of CTV2 defined as 5 mm anterior to the choanae), or standard CTV delineation radiotherapy (anterior border of CTV2 defined as the posterior 1/3 of the nasal cavity).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reduced delineation arm | Experimental | Radiation: reduced CTV delineation |
| Standard delineation arm | Active comparator | Radiation: standard CTV delineation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Newly diagnosed, histologically confirmed non-keratinizing carcinoma (WHO classification).
- Stage I-III disease (AJCC 9th edition).
- Tumor extends to nasal cavity (including nasal septum).
- No distant metastasis (M0).
- Age 18-70 years.
Key exclusion criteria (9 listed)
- Keratinizing squamous cell carcinoma (WHO Type I) or basaloid squamous cell carcinoma.
- Age <18 or >70 years.
- Recurrent disease or distant metastasis.
- No tumor extension into the nasal cavity (including the nasal septum).
- Prior malignancy (except adequately treated basal/squamous cell skin cancer or cervical carcinoma in situ).
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 |
|---|---|---|
| standard CTV delineationThe anterior border of CTV2 is delineated at the posterior 1/3 of the nasal cavity. | Radiation | Standard delineation arm |
| reduced CTV delineationThe anterior border of CTV2 is defined as 5 mm anterior to the posterior nasal cavity anteriorly from the choanae. | Radiation | Reduced delineation arm |
Primary outcome
Local relapse-free survival
Time frame: 3 year
The time from randomization to documented local relapse or death from any cause.
6 secondary outcomes
Overall survival
Time frame: 3 year
Progression-free survival
Time frame: 3 year
Distant metastasis-free survival
Time frame: 3 year
Regional relapse-free survival
Time frame: 3 year
Incidence rate of adverse events (AEs)
Time frame: 2 year
Change of quality of life
Time frame: 1 year
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 18 Jul 2025.
- Background: PubMed 36746459Mao YP, Wang SX, Gao TS, Zhang N, Liang XY, Xie FY, Zhang Y, Zhou GQ, Guo R, Luo WJ, Li YJ, Liang SQ, Lin L, Li WF, Liu X, Xu C, Chen YP, Lv JW, Huang SH, Liu LZ, Li JB, Tang LL, Chen L, Sun Y, Ma J. Medial retropharyngeal nodal region sparing radiotherapy versus standard radiotherapy in patients with nasopharyngeal carcinoma: open label, non-inferiority, multicentre, randomised, phase 3 trial. BMJ. 2023 Feb 6;380:e072133. doi: 10.1136/bmj-2022-072133.
- Background: PubMed 30712708Sanford NN, Lau J, Lam MB, Juliano AF, Adams JA, Goldberg SI, Lu HM, Lu YC, Liebsch NJ, Curtin HD, Chan AW. Individualization of Clinical Target Volume Delineation Based on Stepwise Spread of Nasopharyngeal Carcinoma: Outcome of More Than a Decade of Clinical Experience. Int J Radiat Oncol Biol Phys. 2019 Mar 1;103(3):654-668. doi: 10.1016/j.ijrobp.2018.10.006. Epub 2018 Oct 15.
- Background: PubMed 40419028Lin SJ, Guo QJ, Liu Q, Ng WT, Ahn YC, AlHussain H, Chan AW, Chow J, Chua MLK, Corry J, Han F, Gregoire V, Harrington KJ, Hu CS, Jensen K, Langendijk JA, Le QT, Lee NY, Lee V, Lin JC, Ma J, Mendenhall WM, O'Sullivan B, Ozyar E, Rosenthal DI, Tao YG, Wang RS, Wee J, Xu ZY, Yi JL, Yom SS, Fan DM, Mai HQ, Pan JJ, Lee AWM. International Consensus Guideline on Delineation of the Clinical Target Volumes at Different Dose Levels for Nasopharyngeal Carcinoma (2024 Version). Int J Radiat Oncol Biol Phys. 2025 Oct 1;123(2):415-431. doi: 10.1016/j.ijrobp.2025.05.019. Epub 2025 May 24.
- Background: PubMed 22178121Lee NY, Zhang Q, Pfister DG, Kim J, Garden AS, Mechalakos J, Hu K, Le QT, Colevas AD, Glisson BS, Chan AT, Ang KK. Addition of bevacizumab to standard chemoradiation for locoregionally advanced nasopharyngeal carcinoma (RTOG 0615): a phase 2 multi-institutional trial. Lancet Oncol. 2012 Feb;13(2):172-80. doi: 10.1016/S1470-2045(11)70303-5. Epub 2011 Dec 15.
- Background: PubMed 19251378Liang SB, Sun Y, Liu LZ, Chen Y, Chen L, Mao YP, Tang LL, Tian L, Lin AH, Liu MZ, Li L, Ma J. Extension of local disease in nasopharyngeal carcinoma detected by magnetic resonance imaging: improvement of clinical target volume delineation. Int J Radiat Oncol Biol Phys. 2009 Nov 1;75(3):742-50. doi: 10.1016/j.ijrobp.2008.11.053. Epub 2009 Feb 27.
- 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.
5 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 standard CTV delineation and reduced CTV delineation in people with Nasopharyngeal Cancinoma (NPC), run by Hai-Qiang Mai,MD,PhD at 5 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 11 inclusion and 9 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 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Contact Hai-Qiang Mai, Dr. (+8602087343380, maihq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local relapse-free survival (time frame: 3 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07072000, which also lists 5 linked publications.
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 18 Jul 2025.