Nasopharyngeal Carcinoma
Conditions
Brief 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.
Interventions
DRUGCapecitabine/Tiggio
Drug: Capecitabine/Tiggio Radical chemoradiotherapy：Induction chemotherapy plus Concurrent chemoradiotherapy Induction chemotherapy：Gemcitabine (1000mg/m2) D1 D8+ nida platinum (80mg/m2) D2 q3w ×3cycle Concurrent chemoradiotherapy：IMRT was used for radiotherapy, during which D1 and D22 were given two cycles of single drug concurrent chemotherapy with nidapatin (100mg/m2).
Sponsors
Jiangxi Provincial Cancer Hospital
Zhejiang Cancer Hospital
Fujian Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival(PFS) | 24 months | PFS was defined as the time from randomization to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first. For target lesions, PD was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. |
Countries
China
Contacts
Primary ContactShaojun Lin, DR
Backup ContactJingfeng Zong, DR
Outcome results
None listed