Nasopharyngeal Carcinoma by AJCC V9 Stage
Conditions
Brief summary
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
RADIATIONOmission 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).
Sponsors
Fujian Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Pathologic diagnosis (pathologically confirmed by nasopharyngeal biopsy) was nasopharyngeal carcinoma; 2. No distant metastatic; 3. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1; 4. Signing informed consent; 5. Follow up regularly and comply with test requirements.
Exclusion criteria
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); 4. Disease progression during IMRT; 5. Previous malignancy or other concomitant malignant diseases; 6. The evaluation information of tumor efficacy can not be obtained; 7. Receive blind treatment in other clinical research; 8. Have or are suffering from other malignant tumors within 5 years (except non- melanoma skin cancer or pre-invasive cervical cancer); 9. Serious complications, such as uncontrolled hypertension, coronary heart disease, diabetes, heart failure, etc; 10. Active systemic infection; 11. No or limited capacity for civil conduct; 12. 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; 13. Pregnancy or lactation period;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Regional failure-free survival | 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
| Measure | Time frame | Description |
|---|---|---|
| overall survival | 3 years | time from the date of the start of chemotherapy to death due to any cause |
| Distant metastasis-free survival | 3 years | The distant metastasis-free survival rate will be estimated using Kaplan-Meier |
| Local failure-free survival | 3 years | until documented treatment local failure or death from any cause. |
| Patient's quality-of-life | 3 years | European Organization for Research and Treatment of Cancer Quality-of-Life Head and Neck Questionnaire |
Countries
China
Contacts
Primary ContactQiaojuan Guo
Outcome results
None listed