NCT06167109

Brief Summary

This is a prospective, single-center clinical trial in eccentric nasopharyngeal carcinoma (NPC) patients. The aim of this study is to evaluate the efficacy and safety of NBI combined with MRI-guided optimized CTV compared with conventional CTV, and to compare the radiotherapy-related adverse events and quality of life between the two groups.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Oct 2023

Typical duration for not_applicable

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 Progress86%
Oct 2023Oct 2026

Study Start

First participant enrolled

October 20, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 12, 2023

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

December 12, 2023

Status Verified

December 1, 2023

Enrollment Period

2.5 years

First QC Date

December 4, 2023

Last Update Submit

December 4, 2023

Conditions

Nasopharyngeal Carcinoma by AJCC V8 Stage

Outcome Measures

Primary Outcomes (2)

  • Acute adverse reactions

    The acute adverse reactions of patients during or after radiotherapy were evaluated with the corresponding standard scales.

    3 months

  • Control rate of non-irradiated area

    36 months

Secondary Outcomes (3)

  • Local recurrence-free survival(LRFS)

    36 months

  • Progress-free survival(PFS)

    36 months

  • Overall survival (OS)

    36 months

Study Arms (2)

Optimized CTV

EXPERIMENTAL

The contralateral CTV1 was defined as a subclinical disease consisting of 5mm margin surrounding GTVnx.The CTV2 was defined as potentially involved regions consisting of 5mm margin surrounding CTV1, and contralateral CTV2 only included the pharyngeal recess.

Radiation: CTV optimized IMRT

Conventional CTV

NO INTERVENTION

The CTV1 was defined as GTVnx + 5 mm + entire nasopharynx mucosa .The CTV2 was defined as GTV1+ 5 mm + corresponding anatomical structures.

Interventions

CTV optimized IMRTRADIATION

The contralateral CTV1 was defined as a subclinical disease consisting of 5mm margin surrounding GTVnx.The CTV2 was defined as a potentially involved regions consisting of 5mm margin surrounding CTV1, and contralateral CTV2 only included the pharyngeal recess.

Optimized CTV

Eligibility Criteria

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

You may qualify if:

  • Males and females ≥18 years of age;
  • ECOG Performance Status 0,1 or 2;
  • Pathologically diagnosed as nasopharyngeal carcinoma;
  • Pretreatment nasopharynx and neck MRI imaging;
  • Nasopharyngeal suspected lesions were examined by NBI endoscopy;
  • Meeting the definition of eccentric NPC with ipsilateral (affected side) staging of T1-4 and contralateral (healthy side) staging of T0;
  • Patients evaluated without contraindications to radiotherapy;
  • Voluntary participation in clinical research, and signed informed consent.

You may not qualify if:

  • Patients who did not successfully undergo all three examinations (MRI, NBI, and endoscopic biopsy);
  • Other rare pathological types, such as adenocarcinoma;
  • Patients with tumor invasion of the clivus;
  • Patients whose contralateral retropharyngeal lymph nodes met the diagnostic criteria;
  • Invasion of paranasal sinuses (except simple sphenoid invasion).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

RECRUITING

Related Publications (1)

  • Song Y, Wang Y, Yang M, Yu X, Li M, Long B, Shu X, Zhang X, Wang F, Wang C, Hu M, Sui JD, Wang Y. Individualization of clinical target volume delineation in eccentric nasopharyngeal carcinoma: a prospective comparative study. Front Oncol. 2025 Aug 4;15:1587764. doi: 10.3389/fonc.2025.1587764. eCollection 2025.

    PMID: 40831921DERIVED

Study Officials

  • Ying Wang, Ph.D, M.D.

    Chongqing University Cancer Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuwei Wang, M.M.

CONTACT

1343616175838664816@qq.com

Ying Wang, Ph.D,M.D.

CONTACT

13996412826yingwang197011@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Director of Chongqing University Cancer Hospital

Study Record Dates

First Submitted

December 4, 2023

First Posted

December 12, 2023

Study Start

October 20, 2023

Primary Completion

May 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

December 12, 2023

Record last verified: 2023-12

Locations

CN(1)