Clincal Study of Reduced Target Radiotherapy Based on The Law and Distribution Characteristics of Cervical Lymph Nodes Metastasis in Nasopharyngeal Carcinoma

First Affiliated Hospital of Kunming Medical University1 site in 1 country20 target enrollmentJanuary 1, 2023

ConditionsToxicity Due to Radiotherapy Nasopharyngeal Carcinoma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Toxicity Due to Radiotherapy
Sponsor: First Affiliated Hospital of Kunming Medical University
Enrollment: 20
Locations: 1
Primary Endpoint: incidence of acute mucosal ulcers with a toxicity grade 3 or above
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To determine whether subtractive radiotherapy can significantly reduce the acute side effects of radiotherapy and improve the quality of life of patients on the basis of ensuring the existing curative effect.

Registry

clinicaltrials.gov

Start Date

January 1, 2023

End Date

March 25, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

First Affiliated Hospital of Kunming Medical University

Responsible Party

Principal Investigator

Zhiqiang, Wang

MD,Phd

First Affiliated Hospital of Kunming Medical University

Eligibility Criteria

Inclusion Criteria

•Histopathologically confirmed nasopharyngeal nonkeratologic carcinoma (differentiated or undifferentiated, i.e., WHO type II or Type III).
•The clinical stage is TanyN2-3M0, III-IVa (AJCC 8th edition stage).
•Patients who have not received radiation therapy before.
•After induction chemotherapy, CR or PR were evaluated by radiography.
•Age 18-65 years old.
•ECOG score of 0-
•Good organ function
•The patient has signed an informed letter and is willing and able to comply with the planned visits, treatment plans, laboratory tests and other research programs.

Exclusion Criteria

•Patients with keratinizing squamous cell carcinoma account for only about 5% of the total pathological types, and the sensitivity of radiotherapy is poor compared with the other two types heterogeneous, so nasopharyngeal carcinoma with pathology of keratinizing squamous cells (WHO type I) is excluded.
•Patients with relapsed and distant metastases.
•The metastatic lymph nodes are located in the target area (Ib zone, the lateral group of the retropharyngeal lymphatic drainage area (VII), and the cervical lymphatic rainage area The medial border moves from top to bottom from the medial border of the common carotid artery to the lateral border, from the annular cartilage to the superior sternal border, sternoclavicular.The triangular area between the anterior and posterior edges of the medial mastoid muscle and the anterior and lateral border of the jugular arteriovenous sheath and lateral border of the thyroid glanddomain).
•Nasopharyngeal primary tumor or retropharyngeal metastatic lymph node invasion of oropharynx.
•Severe heart disease, lung dysfunction, heart function, lung function lower than grade 3 (including grade 3).
•Those whose laboratory test values do not meet the relevant criteria within 7 days before enrollment.
•Those who have participated in clinical trials of other drugs within 3 months before treatment.
•Pregnant or lactating women.
•Patients assessed by investigators to be unable to cooperate with regular follow-up due to psychological, social, family and geographical reasons.

Outcomes

Primary Outcomes

incidence of acute mucosal ulcers with a toxicity grade 3 or above

Time Frame: up to 6 months

incidence of acute mucosal ulcers (including those in the oral cavity and pharyngeal wall mucosa) with a toxicity grade 3 or above within 6 months after radiotherapy (that is, between the initiation of radiotherapy to 3 months postradiotherapy) among patients with no recurrence in the reduced-target area