NCT07201337

Brief 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
550

participants targeted

Target at P75+ for phase_3

Timeline
79mo left

Started Nov 2025

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Nov 2025Nov 2032

First Submitted

Initial submission to the registry

September 23, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 1, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2025

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2030

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2032

Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

5 years

First QC Date

September 23, 2025

Last Update Submit

November 13, 2025

Conditions

Nasopharyngeal Cancinoma (NPC)

Keywords

Nasopharyngeal CarcinomaDe-escalationRadiotherapy

Outcome Measures

Primary Outcomes (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.

    3 year

Secondary Outcomes (6)

  • Overall survival

    3 year

  • Failure-free survival

    3 year

  • Distant metastasis-free survival

    3 year

  • Acute toxicities

    3 months

  • Late toxicities

    3 year

  • +1 more secondary outcomes

Study Arms (2)

Reduced-dose Radiotherapy for Low-risk CTV

EXPERIMENTAL
Radiation: Radiation Therapy

Standard-dose Radiotherapy for Low-risk CTV

ACTIVE COMPARATOR
Radiation: Radiation Therapy

Interventions

Radiation TherapyRADIATION

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

Reduced-dose Radiotherapy for Low-risk CTV

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun yat-sen university cancer center

Guangzhou, Guangdong, 510060, China

RECRUITING

Related Publications (5)

  • 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.

    PMID: 38507662RESULT

  • 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.

    PMID: 31319091RESULT

  • 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.

    PMID: 35240053RESULT

  • 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.

    PMID: 36746459RESULT

  • 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.

    PMID: 39970442RESULT

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Hai-Qiang Mai, Ph. D.

CONTACT

+86-020-87343643maihq@sysucc.org.cn

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 23, 2025

First Posted

October 1, 2025

Study Start

November 1, 2025

Primary Completion (Estimated)

November 1, 2030

Study Completion (Estimated)

November 1, 2032

Last Updated

November 17, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)