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NCT Number: NCT07268690

Risk-Adapted Omission of Level Va Irradiation in Nasopharyngeal Carcinoma

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fujian Cancer hospital

Fuzhou, Fujian, 351100, China

Location contact

Qiaojuan Guo, DR

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • Follow up regularly and comply with test requirements.

Exclusion criteria

  • 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;
  • Previous malignancy or other concomitant malignant diseases;
  • The evaluation information of tumor efficacy can not be obtained;
  • Receive blind treatment in other clinical research;
  • Have or are suffering from other malignant tumors within 5 years (except non- melanoma skin cancer or pre-invasive cervical cancer);
  • Serious complications, such as uncontrolled hypertension, coronary heart disease, diabetes, heart failure, etc;
  • Active systemic infection;
  • No or limited capacity for civil conduct;
  • The patient has a physical or mental disorder, and the researcher considers that the patient is unable to fully or fully understand the possible complications of this study;
  • Pregnancy or lactation period;

Treatment and study plan

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).

Primary outcomes

  1. Regional failure-free survival

    Time frame: 3 years

    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.

Secondary outcomes

  1. overall survival

    Time frame: 3 years

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

  2. Distant metastasis-free survival

    Time frame: 3 years

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

  3. Local failure-free survival

    Time frame: 3 years

    until documented treatment local failure or death from any cause.

  4. Patient's quality-of-life

    Time frame: 3 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Qiaojuan Guo

CONTACT

[email protected]

15080013157

Sponsors and collaborators

Lead sponsor

Fujian Cancer Hospital

Other Gov

Registry information

Official study title

Risk-Adapted Omission of Level Va Irradiation in Nasopharyngeal Carcinoma: A Phase III Randomized Non-Inferiority Trial

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Dec 8, 2025
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.