Risk-Adapted Omission of Level Va Irradiation in Nasopharyngeal Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Omission of Level Va Irradiation in Nasopharyngeal Carcinoma.
- Who it may be relevant to
- Registry conditions: Nasopharyngeal Carcinoma by AJCC V9 Stage. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Risk-Adapted Omission of Level Va Irradiation in Nasopharyngeal Carcinoma: A Phase III Randomized Non-Inferiority Trial
Overview
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.
Interventions
- Radiation Omission of Level Va Irradiation in Nasopharyngeal Carcinoma
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 outcome measures
- Regional failure-free survival [Time frame: 3 years]
Secondary outcome measures (4)
- overall survival [Time frame: 3 years]
- Distant metastasis-free survival [Time frame: 3 years]
- Local failure-free survival [Time frame: 3 years]
- Patient's quality-of-life [Time frame: 3 years]
Eligibility criteria
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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Fujian Cancer hospital — Fuzhou
Identifiers
NCT: NCT07268690 · NPC013