Radical Radiotherapy and Chemotherapy Combined With Maintenance Chemotherapy in the Treatment of Stage N3 NPC

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is a randomized, phase II, prospective, multicenter clinical trial to evaluate the efficacy and safety of radical chemoradiotherapy plus oral capecitabine/teggio for 1 year in patients with N3.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fujian Cancer Hospital
• Collaborators: Jiangxi Provincial Cancer Hospital; Zhejiang Cancer Hospital
• Treatments: Capecitabine

Criteria

Inclusion Criteria:

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

2. No distant metastatic stage N3 nasopharyngeal carcinoma was first diagnosed (according to the 8th edition UICC/AJCC nasopharyngeal carcinoma staging system defined as any T and N3M0 stage nasopharyngeal carcinoma).

3. Aged 18-65;

4. At least one measurable tumor lesion;

5. PS (ECOG standard) 0-1;

6. Adequate hematopoietic function: WBC≥3.5×109/L, Hb≥100g/L, PLT≥100×109/L;

7. Normal liver and kidney functions: ALT/AST < 2.5 times the upper limit of normal value (ULN), total bilirubin < 1.5×ULN;Serum creatinine < 1.5×ULN;

8. Expected survival period ≥6 months;

9. Signing informed consent;

10. Follow up regularly and comply with test requirements.

Exclusion Criteria:

1. Patients with distant organ metastasis;

2. Recurrent nasopharyngeal carcinoma;

3. Creatinine clearance rate <60ml/ min;

4. Have received chemotherapy, radiotherapy or targeted therapy;

5. Have or are suffering from other malignant tumors within 5 years (except non-melanoma skin cancer or pre-invasive cervical cancer);

6. Serious complications, such as uncontrolled hypertension, coronary heart disease, diabetes, heart failure, etc.

7. Active systemic infection;

8. History of serious lung or heart disease;

9. Drug or alcohol abuse;

10. No or limited capacity for civil conduct;

11. 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;

12. Receive chronic systemic immunotherapy or hormone therapy outside the study;

13. Pregnancy or lactation period;

14. Patients receive blind treatment in other clinical studies.