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Nasopharyngeal Carcinoma (NPC)Phase 3INCIPT-NPCNCT07303023

Individualized Neck Cervical Irradiation Prophylaxis Trial of NPC

A Phase 3 study testing Individualized Neck Irradiation and Standard Neck Irradiation in people with Nasopharyngeal Carcinoma (NPC), run by Fudan University at 6 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Based on the pattern of nasopharyngeal carcinoma cervical lymph node metastasis, which typically follows a sequential downward spread with rare skip metastases and a tendency for ipsilateral neck involvement, and in accordance with the latest international guidelines, we propose the following scientific hypothesis… Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Nasopharyngeal Carcinoma (NPC)
What is being tested?
Individualized Neck Irradiation and Standard Neck Irradiation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
462 participants
Where
6 sitesChina
Study dates
1 Sep 2025to Sep 2031
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age 18-70 years.
  • Pathologically confirmed WHO type I, II, or III nasopharyngeal carcinoma.
  • Staged as T1-4N0-3 M0, Stage I-III according to the UICC/AJCC 9th edition staging system.
  • Absence of distant metastasis confirmed by systemic FDG PET/CT (or whole-body bone scan plus chest CT and abdominal ultrasound).
  • Ability to undergo MRI examination.
  • Adequate major organ function meeting radiotherapy requirements:
Show all 13Show fewer
  • Hematopoietic function: Hemoglobin ≥9 g/L, Platelets ≥100×10⁹/L, WBC ≥3.5×10⁹/L, Neutrophils ≥2.0×10⁹/L.
  • Liver function: ALT and AST < 2.5 × ULN, Bilirubin < 1.5 × ULN.
  • Renal function: Creatinine clearance ≥50 mL/min or serum creatinine within normal range.
  • Patients with clinical symptoms will be evaluated based on specific manifestations.
  • ECOG performance status 0-1; absence of severe comorbidities (e.g., severe pulmonary hypertension, cardiovascular disease, peripheral vascular disease, severe chronic heart disease) that may preclude radiotherapy. Cardiac function class 1-2 (NYHA classification).
  • Life expectancy ≥12 months.
  • Patients must be informed of the study details and provide written informed consent.

Who cannot join

  • Pathology not confirming WHO type I, II, or III nasopharyngeal carcinoma.
  • Distant metastasis identified clinically or radiologically before treatment, or presence of skip metastases in cervical lymph nodes.
  • Pregnancy (confirmed by serum or urine β-HCG test) or lactation.
  • Unwillingness to provide informed consent.
  • Prior radiotherapy to the head and neck region.
  • Comorbidities or other factors that may contraindicate photon or carbon-ion therapy.
Show all 14Show fewer
  • Inability to comply with regular follow-up due to psychological, social, familial, or geographical reasons.
  • Known allergy to chemotherapeutic agents (e.g., cisplatin, docetaxel, gemcitabine) or contrast media used in the study's imaging examinations.
  • Contraindication to contrast-enhanced MRI.
  • Major organ dysfunction, or severe uncontrolled concurrent infection or medical illness (e.g., decompensated cardiac, pulmonary, renal, or hepatic failure).
  • History of immunodeficiency (positive HIV test), other acquired/congenital immunodeficiency disorders, or history of organ/allogeneic bone marrow transplantation.
  • History of other malignancies prior to enrollment (except for basal cell carcinoma of the skin).
  • History of substance or alcohol abuse.
  • Any other condition deemed by the investigator to potentially lead to study discontinuation, including co-morbidities (including psychiatric) requiring concomitant treatment, severely abnormal laboratory values, or familial/social factors compromising patient safety or data integrity.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Xiyin Guan, MD. PhD. contact

+86-15921292432

forrestguan@163.com

6 sites in 1 country

China6 sites, 6 recruiting

  • Sichuan Cancer Hospital & Institute

    Chengdu

    Lu Li, PhD., +86-13882258173, forrestguan@163.com

    Not yet recruiting

  • Chongqing Cancer Hospital

    Chongqing

    Luo Huang, PhD., +86-13996217508, forrestguan@163.com

    Not yet recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

    Yonghong Hua, PhD., +86-13858032047, forrestguan@163.com

    Not yet recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200000

    xing xing, PhD., +86-15618652456, xingxingplanet@163.com

    Recruiting

  • Eye, Ear, Nose and Throat Hospital of Fudan University

    Shanghai, Shanghai Municipality

    Xiaoshen Wang, PhD., +86-15001805469, forrestguan@163.com

    Not yet recruiting

  • Shanghai Proton and Heavy Ion Center

    Shanghai

    Xiyin Guan, +86-15921292432, forrestguan@163.com

    Xing Xing

    Recruiting

Other trials in China

About this study

Official title: Individualized Versus Standard Neck Prophylactic Irradiation in Nasopharyngeal Carcinoma: A Non-inferiority, Phase III, Multicenter, Prospective, Randomized Controlled Trial

Based on the pattern of nasopharyngeal carcinoma cervical lymph node metastasis, which typically follows a sequential downward spread with rare skip metastases and a tendency for ipsilateral neck involvement, and in accordance with the latest international guidelines, we propose the following scientific hypothesis: individualized neck prophylactic irradiation for nasopharyngeal carcinoma based on the superior-to-inferior extent of metastatic lymph nodes is feasible. Specifically: if there is no lymph node metastasis, irradiation need only extend to the lower border of Level II; if there are suspected metastatic lymph nodes, a prophylactic dose of 55-60 Gy should be administered; the investigational arm will only require irradiation extending to 3 cm below the lowest level of metastatic (including suspected) lymph nodes in each neck.This study will prospectively enroll patients with N0-N3 stage nasopharyngeal carcinoma and randomize them to compare individualized neck irradiation based on the vertebral body level of metastatic lymph nodes versus selective upper neck prophylactic irradiation. The primary endpoint is neck recurrence-free survival. Secondary endpoints include overall survival, local recurrence-free survival and other survival data, incidence of acute and late neck radiation-induced injuries, and quality of life, aiming to validate the feasibility of individualized neck irradiation based on metastatic patterns.Photon IMRT and photon plus carbon-ion radiotherapy will serve as stratification factors, enabling further comparison of local control and toxicity between photon-carbon-ion therapy and photon-only (or proton) therapy. This study seeks to protect critical structures such as the thyroid, trachea, esophagus, and neck muscles while maintaining therapeutic efficacy, ultimately improving the quality of life for nasopharyngeal carcinoma patients.

Read the detailed description

This study is a multicenter, prospective, non-inferiority, open-label, phase III randomized controlled clinical trial. A total of 462 patients will be enrolled, with an anticipated accrual period of three years and a follow-up period of three years post-enrollment.

Eligible patients will have newly diagnosed, non-metastatic nasopharyngeal carcinoma, staged as T1-4N0-3M0, Stage I-III according to the UICC/AJCC 9th edition staging system. After confirmation of the radiotherapy technique, patients will be randomized. Patients in the investigational arm will receive bilateral upper neck irradiation covering at least Level II. If cervical lymph nodes are positive, the clinical target volume (CTV) will extend to 3 cm below the lowest level of metastatic (including suspected) lymph nodes. Patients in the control arm will receive bilateral upper neck irradiation; if upper neck nodes are positive, prophylactic irradiation of the lower neck will be performed. Primary tumor and nodal CTV delineation for both arms will adhere to the 2024 international contouring guidelines for nasopharyngeal carcinoma.

Photon IMRT alone or photon IMRT plus carbon-ion radiotherapy will serve as stratification factors. The prescribed doses for photon IMRT alone are as follows: GTVp and GTVn: 66-70.4 Gy in 30-33 fractions; high-risk CTV1: 60 Gy in 30-33 fractions; low-risk CTV2: 50 Gy in 30-33 fractions. For the combined photon IMRT and carbon-ion radiotherapy arm, the prescription doses are: Photon IMRT - GTVp and GTVn: 55 Gy in 25 fractions; high-risk CTV1: 55 Gy in 25 fractions; low-risk CTV2: 50 Gy in 25 fractions. Carbon-ion boost - GTVp and GTVn: 15-18 Gy (RBE) in 6 fractions.

If indicated, patients will receive induction chemotherapy with the GP regimen (Gemcitabine 1000 mg/m² on Day 1 and Day 8, plus Cisplatin 75 mg/m² divided over three days) for 2-3 cycles. Concurrent chemotherapy, if administered, will consist of Cisplatin 80 mg/m² divided over three days, given every 3 weeks for 2 cycles.

Tumor response will be assessed by EBV-DNA levels and MRI at the end of induction chemotherapy, at the end of concurrent chemoradiotherapy, and three months after treatment completion. Follow-up visits will be scheduled every three months for the first two years post-treatment. Subsequent follow-up will be conducted as per protocol. Quality of life questionnaires, as specified by the study, will be completed before treatment, after treatment completion, and during the follow-up period.

Being tested
Individualized Neck Irradiation, Standard Neck Irradiation
Keywords
IMRT, carbon ion radiotherapy, Prophylactic Neck Irradiation
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Individualized Neck IrradiationRadiation

    After confirmation of the radiotherapy technique, patients will be randomized. Patients in the investigational arm will receive bilateral upper neck irradiation covering at least Level II. If cervical lymph nodes are positive, the clinical target volume (CTV) will extend to 3 cm below the lowest level of metastatic (including suspected) lymph nodes.

  • Standard Neck IrradiationRadiation

    Patients in the control arm will receive bilateral upper neck irradiation to level III; if upper neck nodes are positive, prophylactic irradiation of the lower neck will be performed.

Study groups in NCT07303023
Study groupRoleWhat they receive
investigational armExperimentalNot described
Receives: Radiation: Individualized Neck Irradiation
control armActive comparatorStandard Neck Irradiation
Receives: Radiation: Standard Neck Irradiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. neck recurrence-free survival.

    Measured: 3-year neck recurrence-free survival.

Secondary outcomes (4)

  1. overall survival

    Measured: 3-year

  2. local recurrence-free survival

    Measured: 3-years

  3. Locoregional Recurrence-Free Survival

    Measured: 3 years

  4. Distant Metastasis-Free Survival

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2025
  2. Study start1 Sep 2025
  3. Primary completionSep 2028 (estimated)
  4. Study completionSep 2031 (estimated)

Resources

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
462 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07303023
Sponsor's protocol ID
INCIPT-NPC
Other IDs
2507-83-01
Acronym
INCIPT-NPC
Status last verified
Aug 2025
First submitted
14 Nov 2025
Last updated
24 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Zhu GL, Zhang XM, Yang KB, Tang LL, Ma J. Metastatic patterns of level II-V cervical lymph nodes assessed per vertebral levels in nasopharyngeal carcinoma. Radiother Oncol. 2023 Feb;179:109447. doi: 10.1016/j.radonc.2022.109447. Epub 2022 Dec 19.

    PubMed 36549338

  • Liu Y, Han Y, Liu F, Hu D, Chen Z, Wang P, Li J, Qin J, Jin F, Li Y, Wang J, Yi J. Involved site radiation therapy in stage I-III nasopharyngeal carcinoma with limited lymph node burden (ISRT-NPC) or elective region irradiation: a study protocol for a multicenter non-inferiority randomized controlled phase III clinical trial. BMC Cancer. 2023 Aug 3;23(1):724. doi: 10.1186/s12885-023-11212-7.

    PubMed 37537541

  • Liu Y, Yan W, Hu C, Huang X, Wang K, Qu Y, Chen X, Wu R, Zhang Y, Zhang J, Luo J, Li Y, Wang J, Yi J. Optimizing Cervical Target Volume in Patients with Nasopharyngeal Cancer Based On Nodal Drainage Distance. Clin Cancer Res. 2024 May 1;30(9):1801-1810. doi: 10.1158/1078-0432.CCR-23-3274.

    PubMed 38349999

  • Wang L, Wu Z, He Q, Li Y, Wang S, Li F, Wang H, Li W, Han Y. Distribution of regional lymph nodes metastasis in 870 cases of nasopharyngeal carcinoma and the suggestions for individualized elective prophylactic neck irradiation with intensity-modulated radiotherapy. Cancer Med. 2024 Feb;13(3):e6723. doi: 10.1002/cam4.6723. Epub 2023 Dec 29.

    PubMed 38156901

  • Xie DH, Wu Z, Li WZ, Cheng WQ, Tao YL, Wang L, Lv SW, Lin FF, Cui NJ, Zhao C, Ma J, Huang SM, Lu TX, Han YQ, Su Y. Individualized clinical target volume delineation and efficacy analysis in unilateral nasopharyngeal carcinoma treated with intensity-modulated radiotherapy (IMRT): 10-year summary. J Cancer Res Clin Oncol. 2022 Aug;148(8):1931-1942. doi: 10.1007/s00432-022-03974-7. Epub 2022 Apr 29.

    PubMed 35486182

  • Wu Z, Qi B, Lin FF, Zhang L, He Q, Li FP, Wang H, Han YQ, Yin WJ. Characteristics of local extension based on tumor distribution in nasopharyngeal carcinoma and proposed clinical target volume delineation. Radiother Oncol. 2023 Jun;183:109595. doi: 10.1016/j.radonc.2023.109595. Epub 2023 Mar 3.

    PubMed 36870606

  • Tang LL, Chen L, Xu GQ, Zhang N, Huang CL, Li WF, Mao YP, Zhou GQ, Lei F, Chen LS, Huang SH, Chen L, Chen YP, Zhang Y, Liu X, Xu C, Zhao Y, Li JB, Liu N, Xie FY, Guo R, Sun Y, Ma J. Reduced-volume radiotherapy versus conventional-volume radiotherapy after induction chemotherapy in nasopharyngeal carcinoma: An open-label, noninferiority, multicenter, randomized phase 3 trial. CA Cancer J Clin. 2025 May-Jun;75(3):203-215. doi: 10.3322/caac.21881. Epub 2025 Feb 19.

    PubMed 39970442

  • Huang CL, Zhang N, Jiang W, Xie FY, Pei XQ, Huang SH, Wang XY, Mao YP, Li KP, Liu Q, Li JB, Liang SQ, Qin GJ, Hu WH, Zhou GQ, Ma J, Sun Y, Chen L, Tang LL. Reduced-Volume Irradiation of Uninvolved Neck in Patients With Nasopharyngeal Cancer: Updated Results From an Open-Label, Noninferiority, Multicenter, Randomized Phase III Trial. J Clin Oncol. 2024 Jun 10;42(17):2021-2025. doi: 10.1200/JCO.23.02086. Epub 2024 Mar 20.

    PubMed 38507662

  • Lin 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 40419028

  • Pan JJ, Mai HQ, Ng WT, Hu CS, Li JG, Chen XZ, Chow JCH, Wong E, Lee V, Ma LY, Guo QJ, Liu Q, Liu LZ, Xu TT, Gong XC, Qiang MY, Au KH, Liu TC, Chiang CL, Xiao YP, Lin SJ, Chen YB, Guo SS, Wong CHL, Tang LQ, Xu ZY, Jia YZ, Peng WS, Hu LP, Lu TZ, Jiang F, Cao CN, Xu W, Ma J, Blanchard P, Williams M, Glastonbury CM, King AD, Patel SG, Seethala RR, Colevas AD, Fan DM, Chua MLK, Huang SH, O'Sullivan B, Lydiatt W, Lee AWM. Ninth Version of the AJCC and UICC Nasopharyngeal Cancer TNM Staging Classification. JAMA Oncol. 2024 Oct 10;10(12):1627-35. doi: 10.1001/jamaoncol.2024.4354. Online ahead of print.

    PubMed 39388190

  • Lee AW, Ng WT, Pan JJ, Chiang CL, Poh SS, Choi HC, Ahn YC, AlHussain H, Corry J, Grau C, Gregoire V, Harrington KJ, Hu CS, Kwong DL, Langendijk JA, Le QT, Lee NY, Lin JC, Lu TX, Mendenhall WM, O'Sullivan B, Ozyar E, Peters LJ, Rosenthal DI, Sanguineti G, Soong YL, Tao Y, Yom SS, Wee JT. International Guideline on Dose Prioritization and Acceptance Criteria in Radiation Therapy Planning for Nasopharyngeal Carcinoma. Int J Radiat Oncol Biol Phys. 2019 Nov 1;105(3):567-580. doi: 10.1016/j.ijrobp.2019.06.2540. Epub 2019 Jul 2.

    PubMed 31276776

  • Lee AW, Ng WT, Pan JJ, Poh SS, Ahn YC, AlHussain H, Corry J, Grau C, Gregoire V, Harrington KJ, Hu CS, Kwong DL, Langendijk JA, Le QT, Lee NY, Lin JC, Lu TX, Mendenhall WM, O'Sullivan B, Ozyar E, Peters LJ, Rosenthal DI, Soong YL, Tao Y, Yom SS, Wee JT. International guideline for the delineation of the clinical target volumes (CTV) for nasopharyngeal carcinoma. Radiother Oncol. 2018 Jan;126(1):25-36. doi: 10.1016/j.radonc.2017.10.032. Epub 2017 Nov 15.

    PubMed 29153464

  • Tang LL, Chen YP, Chen CB, Chen MY, Chen NY, Chen XZ, Du XJ, Fang WF, Feng M, Gao J, Han F, He X, Hu CS, Hu DS, Hu GY, Jiang H, Jiang W, Jin F, Lang JY, Li JG, Lin SJ, Liu X, Liu QF, Ma L, Mai HQ, Qin JY, Shen LF, Sun Y, Wang PG, Wang RS, Wang RZ, Wang XS, Wang Y, Wu H, Xia YF, Xiao SW, Yang KY, Yi JL, Zhu XD, Ma J. The Chinese Society of Clinical Oncology (CSCO) clinical guidelines for the diagnosis and treatment of nasopharyngeal carcinoma. Cancer Commun (Lond). 2021 Nov;41(11):1195-1227. doi: 10.1002/cac2.12218. Epub 2021 Oct 26.

    PubMed 34699681

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Individualized Neck Irradiation and Standard Neck Irradiation in people with Nasopharyngeal Carcinoma (NPC), run by Fudan University at 6 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 13 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 24 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 6 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 Xiyin Guan, MD. PhD. (+86-15921292432, forrestguan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

neck recurrence-free survival. (time frame: 3-year neck recurrence-free survival.). 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 NCT07303023, which also lists 13 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 24 Dec 2025.

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