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AzTrials

Nasopharyngeal Cancinoma (NPC)Phase 3NCT07201337

Reduced-dose vs Standard-dose Irradiation for Low-risk Clinical Target Volume in Nasopharyngeal Carcinoma.

A Phase 3 study testing Radiation Therapy in people with Nasopharyngeal Cancinoma (NPC), run by Sun Yat-sen University at 6 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

To evaluate the locoregional control, survival rate, toxicity, and quality of life in patients with nasopharyngeal carcinoma treated with reduced prophylactic irradiation doses to the Low-Risk Clinical Target Volume (CTV). 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?
Radiation Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
700 participants
Where
6 sitesChina
Study dates
17 Nov 2025to 18 Jun 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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Newly diagnosed, untreated, non-distant metastatic, and non-keratinizing NPC; aged between 18 and 70 years; Eastern Cooperative Oncology Group performance score of 0-1; adequate hematologic function (neutrophil count ≥ 1.5 × 10^9/L, platelet count ≥100×109/L, and hemoglobin≥ 90 g/L); adequate renal function (creatinine ≤ 1.5 upper limit of normal [ULN]) or calculated creatinine clearance (CrCl) ≥ 60 mL/min (Cockcroft-Gault formula); and adequate hepatic function (serum bilirubin ≤ 2.0×ULN, and alanine aminotransferase and aspartate aminotransferase ≤ 2.5×ULN).

Who cannot join

  • Previous chemotherapy treatment, surgery (except diagnostic) or radiotherapy to the neck or nasopharyngeal regions; previous malignancy (except for cured basal cell carcinoma or carcinoma in situ of the cervix); lactation or pregnancy; or severe coexisting illness.
  • -

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • Dongguan People's Hospital

    Dongguan, Guangdong

  • Sun yat-sen university cancer center

    Guangzhou, Guangdong, 510060

  • Affiliated Cancer Hospital of Shantou University Medical College

    Shantou, Guangdong

  • Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center

    Shenzhen, Guangdong

  • The University of Hong Kong-Shenzhen Hospital

    Shenzhen, Guangdong

  • Affiliated Hospital of Guangdong Medical University

    Zhanjiang, Guangdong

Other trials in China

About this study

Official title: A Randomized, Open-Label, Non-Inferiority Phase III Multicenter Clinical Trial Comparing Reduced-Dose to Standard-Dose Prophylactic Irradiation for Low-Risk Clinical Target Volume (CTV) in the Treatment of Nasopharyngeal Carcinoma.

To evaluate the locoregional control, survival rate, toxicity, and quality of life in patients with nasopharyngeal carcinoma treated with reduced prophylactic irradiation doses to the Low-Risk Clinical Target Volume (CTV).

Read the detailed description

This phase 3, multicenter, non-inferiority, randomized controlled clinical trial recruits patients with newly diagnosed, untreated, non-distant metastatic, non-keratinizing nasopharyngeal carcinoma (NPC). The intervention involves comparing reduced-dose prophylactic irradiation to standard-dose prophylactic irradiation for the low-risk clinical target volume (CTV). The objective is to compare the locoregional control, survival rate, toxicity, and quality of life between the two groups.

Being tested
Radiation Therapy
Keywords
Nasopharyngeal Carcinoma, De-escalation, 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.

  • Radiation TherapyRadiation

    PTVnx：70Gy/33Fr；PTVnd：70Gy/33Fr；PTV1：60Gy/33Fr；PTV2：42Gy/26Fr.

  • Radiation TherapyRadiation

    PTVnx：70Gy/33Fr；PTVnd：70Gy/33Fr；PTV1：60Gy/33Fr；PTV2：54Gy/33Fr.

Study groups in NCT07201337
Study groupRoleWhat they receive
Reduced-dose Radiotherapy for Low-risk CTVExperimentalNot described
Receives: Radiation: Radiation Therapy
Standard-dose Radiotherapy for Low-risk CTVActive comparatorNot described
Receives: Radiation: Radiation Therapy

What is being measured

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

  1. Locoregional relapse-free survival

    Defined as the time from randomization to either documented local and/or regional relapse or death from any cause (except for metastasis), whichever occurred first.

    Measured: 3 year

Secondary outcomes (6)

  1. Overall survival

    Defined as the time from randomization to death from any cause.

    Measured: 3 year

  2. Failure-free survival

    Defined as the time from randomisation to disease recurrence (distant metastasis or locoregional recurrence) or death due to any cause, whichever occurred first.

    Measured: 3 year

  3. Distant metastasis-free survival

    Defined as the time from randomization to documented distant metastasis or death from any cause (except for locoregional relapse).

    Measured: 3 year

  4. Acute toxicities

    Occur within 3 months after RT. Acute radiation-related toxicities are assessed using the National Cancer Institute Common Toxicity Criteria version 5.0 scale.

    Measured: 3 months

  5. Late toxicities

    Occur 3 months after RT, graded according to the Radiation Therapy Oncology Group radiation morbidity scoring criteria

    Measured: 3 year

  6. Patient's quality-of-life

    Quality-of-life (QoL) scores were assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QoL questionnaire Core 30 items (QLQ-C30) version 3.0 and the head and neck cancer module (QLQ-H and N35).

    Measured: 1 year

Timeline

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

  1. First posted1 Oct 2025
  2. Study start17 Nov 2025
  3. Primary completion18 Jun 2029 (estimated)
  4. Study completion18 Jun 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
700 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07201337
Sponsor's protocol ID
2025-FXY-299
Status last verified
Aug 2026
First submitted
23 Sep 2025
Last updated
27 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

  • Sun XS, Liu SL, Luo MJ, Li XY, Chen QY, Guo SS, Wen YF, Liu LT, Xie HJ, Tang QN, Liang YJ, Yan JJ, Lin DF, Bi MM, Liu Y, Liang YF, Ma J, Tang LQ, Mai HQ. The Association Between the Development of Radiation Therapy, Image Technology, and Chemotherapy, and the Survival of Patients With Nasopharyngeal Carcinoma: A Cohort Study From 1990 to 2012. Int J Radiat Oncol Biol Phys. 2019 Nov 1;105(3):581-590. doi: 10.1016/j.ijrobp.2019.06.2549. Epub 2019 Jul 15.

    PubMed 31319091

  • Tang LL, Huang CL, Zhang N, Jiang W, Wu YS, Huang SH, Mao YP, Liu Q, Li JB, Liang SQ, Qin GJ, Hu WH, Sun Y, Xie FY, Chen L, Zhou GQ, Ma J. Elective upper-neck versus whole-neck irradiation of the uninvolved neck in patients with nasopharyngeal carcinoma: an open-label, non-inferiority, multicentre, randomised phase 3 trial. Lancet Oncol. 2022 Apr;23(4):479-490. doi: 10.1016/S1470-2045(22)00058-4. Epub 2022 Feb 28.

    PubMed 35240053

  • 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 36746459

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Radiation Therapy in people with Nasopharyngeal Cancinoma (NPC), run by Sun Yat-sen 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 1 inclusion and 2 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 27 Aug 2026. 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?

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?

Locoregional 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 NCT07201337, 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 27 Aug 2026.

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