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

Chongqing University Cancer Hospital60 enrolled

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Nasopharyngeal Carcinoma by AJCC V8 Stage

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Locations (1)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Acute adverse reactions

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

Time frame: 3 months

Control rate of non-irradiated area

Time frame: 36 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 36 months

Central Contacts

Yuwei Wang, M.M.

CONTACT

13436161758 38664816@qq.com

Ying Wang, Ph.D,M.D.

CONTACT

13996412826 yingwang197011@163.com

Data from ClinicalTrials.gov

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