NCT07072000

Brief 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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
550

participants targeted

Target at P75+ for phase_3

Timeline
76mo left

Started Aug 2025

Longer than P75 for phase_3

Geographic Reach
1 country

5 active sites

Status
not yet 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 Progress11%
Aug 2025Jul 2032

First Submitted

Initial submission to the registry

July 16, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 18, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2030

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2032

Last Updated

July 18, 2025

Status Verified

July 1, 2025

Enrollment Period

5 years

First QC Date

July 16, 2025

Last Update Submit

July 16, 2025

Conditions

Nasopharyngeal Cancinoma (NPC)

Keywords

nasopharyngeal carcinomaradiotherapy

Outcome Measures

Primary Outcomes (1)

  • Local relapse-free survival

    The time from randomization to documented local relapse or death from any cause.

    3 year

Secondary Outcomes (6)

  • Overall survival

    3 year

  • Progression-free survival

    3 year

  • Distant metastasis-free survival

    3 year

  • Regional relapse-free survival

    3 year

  • Incidence rate of adverse events (AEs)

    2 year

  • +1 more secondary outcomes

Other Outcomes (3)

  • Incidence of olfactory dysfunction

    1 year

  • Incidence of acquired nasal cavity stenosis and atresia

    1 year

  • Incidence of radiation-induced sinusitis

    1 year

Study Arms (2)

Reduced delineation arm

EXPERIMENTAL
Radiation: reduced CTV delineation

Standard delineation arm

ACTIVE COMPARATOR
Radiation: standard CTV delineation

Interventions

standard CTV delineationRADIATION

The anterior border of CTV2 is delineated at the posterior 1/3 of the nasal cavity.

Standard delineation arm
reduced CTV delineationRADIATION

The anterior border of CTV2 is defined as 5 mm anterior to the posterior nasal cavity anteriorly from the choanae.

Reduced delineation arm

Eligibility Criteria

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

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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).
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

First People's Hospital of Foshan

Foshan, Guangdong, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Location

Affiliated Hospital of Guangdong Medical University

Zhangjiang, Guangdong, China

Location

The Fourth Affiliated Hospital of Guangxi Medical University

Liuchow, Guangxi, China

Location

Wuzhou Red Cross Hospital

Wuzhou, Guangxi, China

Location

Related Publications (5)

  • 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: 36746459BACKGROUND

  • Sanford 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.

    PMID: 30712708BACKGROUND

  • 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.

    PMID: 40419028BACKGROUND

  • Lee 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.

    PMID: 22178121BACKGROUND

  • Liang 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.

    PMID: 19251378BACKGROUND

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Hai-Qiang Mai, Dr.

CONTACT

+8602087343380maihq@sysucc.org.cn

Qiu-Yan Chen, Dr.

CONTACT

+8602087343380chenqy@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
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 16, 2025

First Posted

July 18, 2025

Study Start

August 1, 2025

Primary Completion (Estimated)

July 31, 2030

Study Completion (Estimated)

July 31, 2032

Last Updated

July 18, 2025

Record last verified: 2025-07

Locations

CN(5)