Individualized Neck Cervical Irradiation Prophylaxis Trial of NPC

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorFudan University

About this trial

Based on the pattern of nasopharyngeal carcinoma cervical lymph node metastasis, which typically follows a sequential downward spread with rare skip metastases and a tendency for ipsilateral neck involvement, and in accordance with the latest international guidelines, we propose the following scientific hypothesis: individualized neck prophylactic irradiation for nasopharyngeal carcinoma based on the superior-to-inferior extent of metastatic lymph nodes is feasible. Specifically: if there is no lymph node metastasis, irradiation need only extend to the lower border of Level II; if there are suspected metastatic lymph nodes, a prophylactic dose of 55-60 Gy should be administered; the investigational arm will only require irradiation extending to 3 cm below the lowest level of metastatic (including suspected) lymph nodes in each neck.This study will prospectively enroll patients with N0-N3 stage nasopharyngeal carcinoma and randomize them to compare individualized neck irradiation based on the vertebral body level of metastatic lymph nodes versus selective upper neck prophylactic irradiation. The primary endpoint is neck recurrence-free survival. Secondary endpoints include overall survival, local recurrence-free survival and other survival data, incidence of acute and late neck radiation-induced injuries, and quality of life, aiming to validate the feasibility of individualized neck irradiation based on metastatic patterns.Photon IMRT and photon plus carbon-ion radiotherapy will serve as stratification factors, enabling further comparison of local control and toxicity between photon-carbon-ion therapy and photon-only (or proton) therapy. This study seeks to protect critical structures such as the thyroid, trachea, esophagus, and neck muscles while maintaining therapeutic efficacy, ultimately improving the quality of life for nasopharyngeal carcinoma patients.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 18-70 years.

Pathologically confirmed WHO type I, II, or III nasopharyngeal carcinoma.

Staged as T1-4N0-3 M0, Stage I-III according to the UICC/AJCC 9th edition staging system.

Absence of distant metastasis confirmed by systemic FDG PET/CT (or whole-body bone scan plus chest CT and abdominal ultrasound).

Disqualifiers

Pathology not confirming WHO type I, II, or III nasopharyngeal carcinoma.

Distant metastasis identified clinically or radiologically before treatment, or presence of skip metastases in cervical lymph nodes.

Pregnancy (confirmed by serum or urine β-HCG test) or lactation.

Unwillingness to provide informed consent.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Individualized Neck Irradiation

    Radiation

    After confirmation of the radiotherapy technique, patients will be randomized. Patients in the investigational arm will receive bilateral upper neck irradiation covering at least Level II. If cervical lymph nodes are positive, the clinical target volume (CTV) will extend to 3 cm below the lowest level of metastatic (including suspected) lymph nodes.

  • Standard Neck Irradiation

    Radiation

    Patients in the control arm will receive bilateral upper neck irradiation to level III; if upper neck nodes are positive, prophylactic irradiation of the lower neck will be performed.

Treatment groups

462 Participants
are divided into 2 treatment groups
Group A: investigational armExperimental treatment 1 intervention
Group B: control armActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

neck recurrence-free survival.

Time frame
3-year neck recurrence-free survival.

Secondary outcomes

1

overall survival

Time frame
3-year
2

local recurrence-free survival

Time frame
3-years
3

Locoregional Recurrence-Free Survival

Time frame
3 years
4

Distant Metastasis-Free Survival

Time frame
3 years

Other outcomes

1

incidence of acute and late neck radiation-induced injuries

Time frame
3-year

Sponsors and contacts

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Fudan University

Lead sponsor

Shanghai Proton and Heavy Ion Center

Sponsor institution