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Recruiting NCT06167109

NBI Combined With MRI to Guide CTV Optimization in Eccentric Nasopharyngeal Carcinoma

No phase Interventional Nasopharyngeal Carcinoma by AJCC V8 Stage

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CTV optimized IMRT.
Who it may be relevant to
Registry conditions: Nasopharyngeal Carcinoma by AJCC V8 Stage. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Endoscopic NBI Combined With MRI to Guide the Optimization of Clinical Target Volume Delineation in Eccentric Nasopharyngeal Carcinoma

Overview

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.

Detailed description

All patients with eccentric nasopharyngeal carcinoma were selected on the basis of MRI findings and NBI endoscopy was performed in these patients. The patients were enrolled if both NBI endoscopy and MRI showed eccentric NPC. Patients with contralateral tissue mucosal abnormalities detected by NBI and confirmed by biopsy were excluded. Then the patients were randomly divided into an experimental group (Optimized CTV) or a control group (Conventional CTV) to evaluate the efficacy and safety of the two groups, as well as radiotherapy-related adverse events.

Interventions

  • Radiation CTV optimized IMRT
    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.

Primary outcome measures

  • Acute adverse reactions [Time frame: 3 months]
  • Control rate of non-irradiated area [Time frame: 36 months]
Secondary outcome measures (3)
  • Local recurrence-free survival(LRFS) [Time frame: 36 months]
  • Progress-free survival(PFS) [Time frame: 36 months]
  • Overall survival (OS) [Time frame: 36 months]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Chongqing University Cancer Hospital — Chongqing

Publications

  • 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 40831921

Identifiers

NCT: NCT06167109 · NPC-CTV

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗