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

Chongqing University Cancer Hospital

Status: Enrolling

Conditions: Nasopharyngeal Carcinoma by AJCC V8 Stage

Treatments: Radiation: CTV optimized IMRT

Study type: Interventional

Funder types: Other

Identifiers

NCT06167109

NPC-CTV

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Optimized CTV

Experimental group

Description:

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.

Treatment:

Radiation: CTV optimized IMRT

Conventional CTV

No Intervention group

Description:

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