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.