Concurrent Cisplatin Chemoradiation With or Without Capecitabine as Adjuvant Chemotherapy in Local Advanced High Risk Nasopharyngeal Carcinoma: Randomized Control Clinical Trial

Study Overview
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Brief Summary
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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.

Official Title
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Concurrent Cisplatin Chemoradiation With or Without Capecitabine as Adjuvant Chemotherapy in Local Advanced High Risk Nasopharyngeal Carcinoma: Randomized Control Clinical Trial

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 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

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) every three weeks for three cycles during RT,followed by adjuvant chemotherapy with oral capecitabine(1000mg/m2/ twice a day for 14 days)every three weeks for eight cycles.<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) every three weeks for three cycles during RT.<br>|

What is the study measuring?
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Primary 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. | 3-year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Toxicity | To evaluate the acute toxicity with CTC 3.0 when concurrent cisplatin chemoradiation with or without capecitabine as adjuvant chemotherapy is used. | 18 months | 

 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