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

Not Applicable

Recruiting

• Conditions: Nasopharyngeal Carcinoma by AJCC V8 Stage
• Interventions: Radiation: CTV optimized IMRT

• Registration Number: NCT06167109
• Lead Sponsor: Chongqing University Cancer Hospital

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.

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.

Study Timeline

• Study Start: 2023-10-20
• Status Verified: 2023-12
• Study First Submitted: 2023-12-04
• Study First Submitted QC: 2023-12-04
• Last Update Submitted: 2023-12-04
• Study First Posted: 2023-12-12
• Last Update Posted: 2023-12-12
• Primary Completion: 2026-05
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Optimized CTV	CTV optimized IMRT	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.

Primary Outcome Measures

Name	Time	Method
Acute adverse reactions	3 months	The acute adverse reactions of patients during or after radiotherapy were evaluated with the corresponding standard scales.
Control rate of non-irradiated area	36 months

Secondary Outcome Measures

Name	Time	Method
Progress-free survival(PFS)	36 months	Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first.
Local recurrence-free survival(LRFS)	36 months	The duration of time to LRFS was calculated from the date of histological diagnosis until documented treatment local failure or death from any cause.
Overall survival (OS)	36 months	Overall survival is measured from day of diagnosis until death due to any cause or the latest known date alive.

Trial Locations

Locations (1)

Chongqing University Cancer Hospital; 🇨🇳 Chongqing, Chongqing, China