A Multicenter Trial Evaluating the Efficacy of Nedaplatin in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Study Overview
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Brief Summary
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This study is a multicenter trial.The primary objective is to estimate short-term efficacy and acute toxicities of nedaplatin to the combination of docetaxel in neoadjuvant chemotherapy followed by nedaplatin in concurrent chemoradiotherapy, compared to cisplatin to the combination of docetaxel in neoadjuvant chemotherapy followed by cisplatin in concurrent chemoradiotherapy for patients with locoregionally advanced nasopharyngeal carcinoma. Secondary objectives are to evaluate the overall survival, the distant metastases free survival, and disease free survival of patients with locoregionally advanced nasopharyngeal carcinoma treated with these regimens.Furthermore,analyze the cost-effectiveness of the regimens.

Detailed Description
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Patients with clinical stage T3-4N1/N2-3 (UICC 7th edition)are divided into two groups according to informed consent:intensity-modulated radiation therapy（IMRT）group and conventional fractionation radiotherapy(CRT)group. Then the patients in IMRT group/CRT group are randomly assigned to receive nedaplatin+docetaxel in neoadjuvant chemotherapy plus nedaplatin alone in concurrent chemoradiotherapy or cisplatin+docetaxel in neoadjuvant chemotherapy plus cisplatin alone in concurrent chemoradiotherapy.Evaluate the overall survival, the distant metastases free survival, and disease free survival of the patients treated with these regimens.Furthermore,analyze the cost-effectiveness of the regimens.

Official Title
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A Multicenter Trial Evaluating the Efficacy and Safety of Nedaplatin Plus Docetaxel in Neoadjuvant Chemotherapy Followed by Nedaplatin in Concurrent Chemoradiation for Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Conditions
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Nasopharyngeal Carcinoma

Intervention / Treatment
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* Drug: nedaplatin and docetaxel
* Drug: cisplatin and docetaxel
* Drug: nedaplatin and docetaxel
* Drug: cisplatin and docetaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically proven nasopharyngeal carcinoma for primary treatment with radical intent non-keratinizing or undifferentiated type clinical stage III-IVb (UICC 7th edition) age between 18-70 satisfactory performance status: Karnofsky scale (KPS) > 70. hemoglobin > 100g/L, WBC > 4.0x10*9/L, Plt > 100x10*9/L serum creatinine level < 1.6 mg/dL or creatinine clearance ≥ 60 mL/min. normal liver function test: Alanine Aminotransferase (ALT)、Aspartate Aminotransferase (AST) <1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤2.5×ULN, and bilirubin ≤1.5ULN patients must be informed of the investigational nature of this study and give written informed consent. anticipated life span more than 6 month Exclusion Criteria: primary treatment with palliative intent WHO Type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma Evidence of distant metastases pregnancy or lactation history of previous radiotherapy (except for non-melanomatous skin cancers outside intended RT treatment volume). prior chemotherapy or surgery (except diagnostic) to primary tumor or nodes prior malignancy except adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer or other cancer for which the patient has been disease-free for 5 years any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose >1.5×ULN), and emotional disturbance.

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: 1A(nedaplatin and IMRT)<br>neoadjuvant chemotherapy using nedaplatin plus docetaxel followed by concurrent chemotherapy using nedaplatin and Intensity-modulated Radiation Therapy(IMRT) | Drug: nedaplatin and docetaxel<br>* neoadjuvant chemotherapy: nedaplatin 80mg/m2+docetaxel 65 mg/m2/day,every 21 days for 2 cycles before radiotherapy concurrent chemotherapy: nedaplatin 40mg/m2,weekly,for 6 cycles during radiotherapy<br>* Other names: TN;|
| Active Comparator: 1B(cisplatin and IMRT)<br>neoadjuvant chemotherapy using cisplatin plus docetaxel followed by concurrent chemotherapy using cisplatin and Intensity-modulated Radiation Therapy(IMRT) | Drug: cisplatin and docetaxel<br>* neoadjuvant chemotherapy: cisplatin 80mg/m2+docetaxel 65 mg/m2/day,every 21 days for 2 cycles before radiotherapy concurrent chemotherapy: cisplatin 40mg/m2,weekly,for 6 cycles during radiotherapy<br>* Other names: TP;|
| Experimental: 2A(nedaplatin and CRT)<br>neoadjuvant chemotherapy using nedaplatin plus docetaxel followed by concurrent chemotherapy using nedaplatin and conventional fractionation radiotherapy(CRT) | Drug: nedaplatin and docetaxel<br>* neoadjuvant chemotherapy: nedaplatin 80mg/m2+docetaxel 65 mg/m2/day,every 21 days for 2 cycles before radiotherapy concurrent chemotherapy: nedaplatin 40mg/m2,weekly,for 6 cycles during radiotherapy<br>* Other names: TN;|
| Active Comparator: 2B((cisplatin and CRT))<br>neoadjuvant chemotherapy using cisplatin plus docetaxel followed by concurrent chemotherapy using cisplatin and conventional fractionation radiotherapy(CRT) | Drug: cisplatin and docetaxel<br>* neoadjuvant chemotherapy: cisplatin 80mg/m2+docetaxel 65 mg/m2/day,every 21 days for 2 cycles before radiotherapy concurrent chemotherapy: cisplatin 40mg/m2,weekly,for 6 cycles during radiotherapy<br>* Other names: TP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete response (CR) rate | 3 months after treatment | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute toxicities | Acute toxicity will be measured by CTCAE3.0 | 2 years | 
| Overall Survival | 1 years，3 years and 5 years overall survival,disease free survival,distant metastases free survival | 1,3,5 years | 
| cost-effectiveness ratio | Calculate the cost(C) and complete response rate(E) of each group 3 months after treatment,then calculate cost-effectiveness ratio(C/E). | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nasopharyngeal Carcinoma, neoadjuvant chemotherapy, concurrent chemoradiotherapy, Nedaplatin