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

NCT ID: NCT06167109

Last Updated: 2023-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-20

Study Completion Date

2026-10-31

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.

Conditions

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Nasopharyngeal Carcinoma by AJCC V8 Stage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Optimized CTV

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.

Group Type EXPERIMENTAL

CTV optimized IMRT

Intervention Type RADIATION

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.

Conventional CTV

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type RADIATION

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chongqing University Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ying Wang

Associate Director of Chongqing University Cancer Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ying Wang, Ph.D, M.D.

Role: PRINCIPAL_INVESTIGATOR

Chongqing University Cancer Hospital

Locations

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Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yuwei Wang, M.M.

Role: CONTACT

Phone: 13436161758

Email: [email protected]

Ying Wang, Ph.D,M.D.

Role: CONTACT

Phone: 13996412826

Email: [email protected]

Facility Contacts

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Yuwei Wang, M.M.

Role: primary

Ying Wang, Ph.D, M. D.

Role: backup

References

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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.

Reference Type DERIVED
PMID: 40831921 (View on PubMed)

Other Identifiers

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NPC-CTV

Identifier Type: -

Identifier Source: org_study_id