Induction Cisplatin and Capecitabine Followed by Concurrent Chemoradiotherapy for Nasopharyngeal Carcinoma

Study Overview
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Brief Summary
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To prospectively evaluate the short-term efficacy and toxicity of induction chemotherapy with cisplatin and capecitabine followed by concurrent chemoradiotherapy (CCRT) in the treatment of locally advanced nasopharyngeal carcinoma.

Detailed Description
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All patients received 3 cycles of induction chemotherapy:cisplatin 80mg/m2, day 1; oral capecitabine 1000mg/m2 twice daily from day1-14, repeated every 3 weeks followed by concomitant cisplatin (100mg/m2,day1,every 3 weeks) for a total of 2 cycles with radiotherapy. Intensity-modified radiotherapy (IMRT) were used in all patients with the total dose and dose/fraction (Fr) as follows: PTV (planned target volume)_1:70 grays (Gy) at 2 Gy/ Fr, PTV_2:63 Gy at 1.8 Gy/ Fr, PTV_3:56 Gy at 1.6 Gy/ Fr;5 fractions per week. Tumor response was evaluated after 3 cycles of induction chemotherapy and 16 weeks following completion of CCRT according to the Response Evaluation Criteria in Solid Tumors 1.1 (RECIST1.1). All toxicities were gauged based on the Common Terminology Criteria for Adverse Events version 4.03 (CTCAE 4.03).

Official Title
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The Efficacy of Induction Chemotherapy With Cisplatin and Capecitabine Followed by Concurrent Chemoradiotherapy for Locally Advanced Nasopharyngeal Carcinoma

Conditions
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Nasopharyngeal Carcinoma

Intervention / Treatment
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* Drug: cisplatin, capecitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathological confirmed nasopharyngeal carcinoma. Staged as III to IVB. 18-75 years old. Performance status ≤2. No previous chemotherapy or radiotherapy. No concurrent malignancies or a history of other malignancies. Adequate bone marrow function (absolute neutrophil count ≥1.5×109/L, platelets ≥100×109/L). Adequate liver and renal function (serum bilirubin and serum transaminase levels less than twice the upper limit of normal, creatinine clearance ≥ 60ml/min). Without serious co-morbidity. Exclusion Criteria: Stage I-II or IVC. Allergic to cisplatin or capecitabine Age <18 or >75 Performance Status >2. Without adequate bone marrow or liver function or renal function. Severe co-morbidity and can not tolerate chemotherapy. Other conditions not suitable for the study on the discretion of charging doctor.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Intervention Model: Single Group Assignment
Interventional Model Description: All patients received 3 cycles of induction chemotherapy (cisplatin 80mg/m2, day 1; oral capecitabine 1000mg/m2 twice daily from day1-14, repeated every 3 weeks) followed by concomitant cisplatin (100mg/m2,day1,every 3 weeks) for a total of 2 cycles with radiotherapy.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experimental arm<br>Induction chemotherapy: capecitabine tablet 1000mg/m2 po bid from day1 to 14,cisplatin injection 80mg/m2 iv day1,every 3 weeks for a total of 3 cycles. Then followed by concurrent chemoradiotherapy with cisplatin injection 100mg/m2 iv every 3 weeks for a total of 2 cycles. | Drug: cisplatin, capecitabine<br>* Experimental arm patients received 3 cycles of induction chemotherapy (cisplatin 80mg/m2, day 1; oral capecitabine 1000mg/m2 twice daily from day1-14, repeated every 3 weeks) followed by concomitant cisplatin (100mg/m2,day1,every 3 weeks) for a total of 2 cycles with radiotherapy.<br>* Other names: chemoradiotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS (progression free survival) | progression free survival | From date of first treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cisplatin, nasopharyngeal carcinoma, induction chemotherapy, capecitabine, chemoradiotherapy