Risk-Adapted Omission of Level Va Irradiation in Nasopharyngeal Carcinoma

Fujian Provincial Cancer Hospital

Status and phase: Not yet enrolling; Phase 3

Conditions: Nasopharyngeal Carcinoma by AJCC V9 Stage

Treatments: Radiation: Omission of Level Va Irradiation in Nasopharyngeal Carcinoma

Study type: Interventional

Funder types: Other

Identifiers

NCT07268690

NPC013

Details and patient eligibility

About

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.

Enrollment: 474 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

474 participants in 2 patient groups

level Va-sparing IMRT

Experimental group

Description:

Level Va irradiation is omitted except 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:

Radiation: Omission of Level Va Irradiation in Nasopharyngeal Carcinoma

level Va-covering IMRT

No Intervention group

Description:

Level Va is routinely irradiated according to CACA/CMDA guidelines.