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Risk-Adapted Omission of Level Va Irradiation in Nasopharyngeal Carcinoma

ConditionNasopharyngeal Carcinoma by AJCC V9 Stage
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorFujian Cancer Hospital

About this trial

This is a randomized, phase III, prospective, multi-center trial in newly diagnosed nasopharyngeal carcinoma (NPC) patients without distant metastasis. This study will evaluate whether omitting Level Va irradiation in patients without these risk features does not compromise regional control or survival, with the goal of providing robust evidence to guide further personalization of NPC radiotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Pathologic diagnosis (pathologically confirmed by nasopharyngeal biopsy) was nasopharyngeal carcinoma;

No distant metastatic;

Eastern Cooperative Oncology Group (ECOG) score of 0 or 1;

Signing informed consent;

Disqualifiers

Ipsilateral Level IIb involvement;

Ipsilateral Level III nodes involvement;

Ipsilateral positive lymph nodes below the cricoid cartilage (Level IV or Vb-c);

Disease progression during IMRT;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Omission of Level Va Irradiation in Nasopharyngeal Carcinoma

    Radiation

    Level Va should be irradiated only in the presence of any of the following high-risk features: 1. Ipsilateral Level IIb involvement; 2. Ipsilateral Level III nodes involvement; 3. Ipsilateral positive lymph nodes below the cricoid cartilage (Level IV or Vb-c).

Treatment groups

474 Participants
are divided into 2 treatment groups
Group A: level Va-sparing IMRTExperimental treatment 1 intervention
Group B: level Va-covering IMRTNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Regional failure-free survival

The regional relapse-free survival rate will be estimated using Kaplan-Meier method for each arm from the date of randomization to the date of nodal relapse or death from any cause, whichever occurred first. Their differences will be compared between treatment arms using the log-rank test.

Time frame
3 years

Secondary outcomes

1

overall survival

time from the date of the start of chemotherapy to death due to any cause

Time frame
3 years
2

Distant metastasis-free survival

The distant metastasis-free survival rate will be estimated using Kaplan-Meier

Time frame
3 years
3

Local failure-free survival

until documented treatment local failure or death from any cause.

Time frame
3 years
4

Patient's quality-of-life

European Organization for Research and Treatment of Cancer Quality-of-Life Head and Neck Questionnaire

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fujian Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: