Overview

Optimization of Cervical Nodal Clinical Tumor Volume for Early and Medium Stage Nasopharyngeal Carcinoma

Status:
Not yet recruiting
Trial end date:
2026-09-30
Target enrollment:
0
Participant gender:
All
Summary
The regional failure rate of early to mid-stage nasopharyngeal carcinoma is low and recurrence is mainly in high-dose areas within the target area. The purpose of this study was to investigate whether a strategy of irradiating the affected site to narrow the clinical target area of high-risk lymph nodes (ISI) could significantly reduce treatment-related toxicities without compromising regional control rates compared with a conventional regimen (ERI).
Phase:
Phase 3
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Jun-Lin Yi, MD
Treatments:
Cisplatin
Criteria
Inclusion Criteria:

- age 18 to 70 years, regardless of gender.

- histologically confirmed nasopharyngeal carcinoma.

- T1-3N0-2 (stageII-III) with metastatic lymph nodes ≤ 4 cm in maximum diameter and no
extra nodal extension(ENE).

- KPS score ≥ 70.

- completed pre-treatment CT/MRI imaging data (including functional MRI sequences) with
measurable tumor lesions.

- the first course of therapy.

- expected survival longer than 6 months.

- laboratory criteria: Hb >120g/L, white blood cells ≥4x109 /L, ≥100x109 /L, liver and
kidney function indicators within the upper limit of normal values 1.25 more range; no
hearing impairment.

- can understand the study and have signed the informed consent form.

- have the conditions for follow-up.

Exclusion Criteria:

- maximum diameter of metastatic lymph nodes > 4 cm.

- gross melted Cervical lymph nodes or extra nodal extension.

- jumping metastases of cervical lymph nodes.

- T4 or N3 stage.

- has other malignancies (other than stage I non-melanotic skin cancer or carcinoma in
situ of the cervix).

- has received other tumor-related treatment.

- pregnant or breastfeeding, and women of childbearing age.

- undergoing trials of other drugs.

- with severe comorbidities, including myocardial infarction, severe arrhythmias, severe
cerebrovascular disease, ulcer disease, psychiatric disorders and uncontrollable
diabetes mellitus.

- do not have the condition of regular follow-up.