Concurrent Cisplatin Chemoradiation With or Without Capecitabine as Adjuvant Chemotherapy in Local Advanced High Risk Nasopharyngeal Carcinoma: Randomized Control Clinical Trial
Overview
- Phase
- Phase 3
- Intervention
- IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy
- Conditions
- Local Advanced High Risk Nasopharyngeal Carcinoma
- Sponsor
- Zhao Chong
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Failure free survival
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This is an randomized controlled, multicenter clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy in local advanced high risk nasopharyngeal carcinoma.
Investigators
Zhao Chong
MD
Sun Yat-sen University
Eligibility Criteria
Inclusion Criteria
- •Newly histologic diagnosis of nasopharyngeal carcinoma(WHO II/III)
- •Clinical stage III\~IVb(UICC 7th)
- •Meet at least one factor below :1 primary tumor SUVmax\>10 in 18F-FDG PET/CT;2 primary tumor volume\>30cm3;3 mutiple metastatic cervical lymph node with at least one's short diameter\>4cm; 4 T4N2M0; 5 T1-4N3M0;6 EBV-DNA\>2×10E4 copy/l
- •Range from 18～70 years old
- •WBC count ≥ 4×109/L，Hemoglobin ≥ 100g/L， platelet count ≥ 100×109/L
- •ALT or AST \< 2.5×ULN、bilirubin \< 1.5×ULN
- •OSerum creatinine \< 1.5×ULN
Exclusion Criteria
- •Central nervous system metastases
- •Suitable for local treatment
- •Uncontrolled seizure disorder or other serious neurologic disease
- •Clinically significant cardiac or respiratory disease
- •Drug or alcohol addition
- •Do not have full capacity for civil acts
- •Severe complication, active infection
- •Concurrent immunotherapy or hormone therapy for other diseases
- •Pregnancy or lactation
Arms & Interventions
Concurrent chemoradiation + adjuvant chemotherapy
IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy
Intervention: IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy
Concurrent chemoradiation
IMRT combine with cisplatin concurrent chemotherapy
Intervention: IMRT combine with cisplatin concurrent chemotherapy
Outcomes
Primary Outcomes
Failure free survival
Time Frame: 3-year
Defined as the time from date of recruitment to documented relapse or death from any cause.
Secondary Outcomes
- Acute Toxicity(18 months)