NCT06241612

Brief Summary

To evaluate whether individualized elective neck irradiation for nasopharyngeal carcinoma based on the vertebral level of metastatic lymph nodes can reduce the incidence of radiation-related adverse effects and improve patients' quality of life，without reducing survival.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
470

participants targeted

Target at P50-P75 for phase_3

Timeline
69mo left

Started Apr 2024

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 Progress27%
Apr 2024Dec 2031

First Submitted

Initial submission to the registry

January 28, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 5, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

April 16, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2031

Last Updated

September 17, 2025

Status Verified

July 1, 2025

Enrollment Period

2.7 years

First QC Date

January 28, 2024

Last Update Submit

September 10, 2025

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Regional relapse-free survival

    The regional relapse-free survival rate will be estimated using Kaplan-Meier method for each arm from the date of randomization to the date of nodal relapse or death from any cause, whichever occurred first. Their differences will be compared between treatment arms using the log-rank test.

    3 years

Secondary Outcomes (5)

  • Radiation-related toxicity

    Within 3 month after radiotherapy for acute toxicity; long term for late toxicity

  • Overall survival

    3 years

  • Local relapse-free survival

    3 years

  • Distant metastasis-free survival

    3 years

  • Patient's quality-of-life: global health status

    3 years

Study Arms (2)

Standard group

ACTIVE COMPARATOR

Upper-neck irradiation at the uninvolved neck

Radiation: Individualized Elective Neck Irradiation

Experimental group

EXPERIMENTAL

The low-risk clinical target volume would be reduced to two vertebral levels below the vertebral level of the metastatic level II-V nodes.

Radiation: Individualized Elective Neck Irradiation

Interventions

Individualized Elective Neck IrradiationRADIATION

Individualized Elective Neck Irradiation

Experimental groupStandard group

Eligibility Criteria

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

You may qualify if:

  • The eligibility criteria are: newly diagnosed, untreated, non-distant metastatic, and non-keratinizing NPC; nodes are diagnosed with PET/CT and MRI; staged as T1-4N0-2 or N3 category of non-bilateral lower-neck node metastasis; aged between 18 and 70 years; Karnofsky performance-status score \> 70; adequate haematological function, with a leucocyte count \> 4 × 109/L, haemoglobin \> 90 g/L, and a thrombocyte count \> 100×109/L

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

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

Ling-Long Tang, Prof

CONTACT

02087343840tangll@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
Prof.

Study Record Dates

First Submitted

January 28, 2024

First Posted

February 5, 2024

Study Start

April 16, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2031

Last Updated

September 17, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)