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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Nasopharyngeal Carcinoma by AJCC V8 Stage

Intervention / Treatment
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* Radiation: CTV optimized IMRT


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Optimized CTV<br>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<br>* 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.<br>|
| No Intervention: Conventional CTV<br>The CTV1 was defined as GTVnx + 5 mm + entire nasopharynx mucosa .The CTV2 was defined as GTV1+ 5 mm + corresponding anatomical structures. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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