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

Fujian Provincial Cancer Hospital

Status and phase: Unknown; Phase 2

Conditions: Nasopharyngeal Carcinoma

Treatments: Drug: Capecitabine/Tiggio

Study type: Interventional

Funder types: Other

Identifiers

NCT04220528

NPC002.1

Details and patient eligibility

About

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.

Enrollment: 129 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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129 participants in 1 patient group

Radical chemoradiotherapy plus oral capecitabine/teggiol

Experimental group

Description:

Patients with newly diagnosed, non-metastatic stage N3 NPC was given Teggio 40-60mg bid d1-14, q4w, oral maintenance chemotherapy for 1 year or capecitabine 2500mg/m2/d twice daily oral d1-14, q4w after receiving radical chemoradiotherapy.

Treatment:

Drug: Capecitabine/Tiggio