Prognostic Analysis of Concurrent Chemoradiotherapy With/Without Adjuvant Chemotherapy for Locally Advanced NPC Patients

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Local Advanced High Risk Nasopharyngeal Carcinoma

Intervention / Treatment
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* Drug: IMRT combine with cisplatin concurrent chemotherapy
* Drug: IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Concurrent chemoradiation + adjuvant chemotherapy<br>IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy | Drug: IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy<br>* Patients in the experimental arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1 and day 22) during RT,followed by adjuvant chemotherapy with oral capecitabine(1000mg/m2/ twice a day for 14 days)every three weeks for eight cycles at 4 weeks later after RT.<br>|
| Active Comparator: Concurrent chemoradiation<br>IMRT combine with cisplatin concurrent chemotherapy | Drug: IMRT combine with cisplatin concurrent chemotherapy<br>* Patients in the control arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1 and day 22) during RT.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distant metastasis-free survival | Defined as the time from date of recruitment to documented distant metastasis or death from any cause. | Five year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure-free survival | Defined as the time from date of recruitment to documented relapse or death from any cause. | Five year | 
| Locoregional relapse-free survival | Defined as the time from date of recruitment to documented locoregional relapse or death from any cause. | Five year | 
| Overall survival | Defined as the time from date of recruitment to death from any cause. | Five year | 
| Acute toxicity | Acute toxicities were graded using the Common Toxicity Criteria for Adverse Events version 4.0 (CTCAE v4.0) for chemotherapy-specific toxicities, and the Radiation Therapy Oncology Group (RTOG) radiation morbidity scoring criteria for radiotherapy-specific toxicities. | three months after corresponding treatment | 
| Late toxicity | Late toxicities were assessed annually using the RTOG radiation morbidity scoring criteria. | Five year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Local advanced, High Risk, Nasopharyngeal Carcinoma