Randomized Trial of Concurrent Cisplatin Chemoradiotherapy Plus Capecitabine Adjuvant Chemotherapy vs Concurrent Cisplatin Chemoradiotherapy Alone for Patients With Local Advanced Nasopharyngeal Carcinoma at High Risk of Distant Metastasis
Overview
- Phase
- Phase 3
- Intervention
- IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy
- Conditions
- Local Advanced High Risk Nasopharyngeal Carcinoma
- Sponsor
- Sun Yat-sen University
- Enrollment
- 294
- Locations
- 1
- Primary Endpoint
- Distant metastasis-free survival
- Status
- Completed
- Last Updated
- 2 months ago
Overview
Brief Summary
This is a randomized,controlled,prospective phase III 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 Nasopharyngeal Carcinoma at High Risk of Distant Metastasis.Exploring an Individualized comprehensive treatment plan which is reasonable,effective,low toxicity and fitting with Modern radiotherapy techniques for Local Advanced Nasopharyngeal Carcinoma at High Risk of Distant Metastasis.
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/AJCC 7th)
- •No distant metastasis
- •Karnofsky Performance Status Scale≥70
- •WBC count ≥ 4×109/L, neutrophil differential count≥ 1.5×109/L, Hemoglobin ≥ 90g/L, platelet count ≥ 100×109/L
- •ALT or AST ≤2.5×ULN,bilirubin ≤2.5×ULN, Serum creatinine ≤1.5×ULN or Serum creatinine clearance≥60ml/min
- •Sign the informed consent.
Exclusion Criteria
- •Angle of sexual squamous cell carcinomas and basal cell layout, squamous cell carcinomas
- •Younger than 18 years old or older than 70 years old
- •Are receiving other drugs treanment
- •kidney disease
- •Have suffered from other tumor or now suffering from other tumor
- •Have recieved chemotherapy or radiotherapy
- •Pregnancy or lactation
- •unstable heart disease need timely treatment
- •Severe cerebrovascular disease/canker/psychosis/uncontrolled diabetes
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
Distant metastasis-free survival
Time Frame: Five year
Defined as the time from date of recruitment to documented distant metastasis or death from any cause.
Secondary Outcomes
- Locoregional relapse-free survival(Five year)
- Overall survival(Five year)
- Acute toxicity(three months after corresponding treatment)
- Failure-free survival(Five year)
- Late toxicity(Five year)