Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Study Overview
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Brief Summary
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This is a Phase II Randomized Trial to Compare Paclitaxel combined with DDP Plus Concurrent Chemoradiotherapy With DDP Plus Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Detailed Description
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Nasopharyngeal carcinoma is one of the most common malignancies in South China. Nasopharyngeal carcinoma is sensitive to radiotherapy and chemotherapy. Concurrent chemoradiation has become a standard treatment for locally advanced stage III-IVb nasopharyngeal carcinoma. However, The recommended single-agent DDP concurrent chemotherapy regimen for high-risk patients (IVa-IVb period) to improve the efficacy was not significant. Paclitaxel combined with platinum in the same period of chemotherapy regimen has been widely used in head and neck cancer, cervical cancer, esophageal squamous cell carcinoma and lung cancer and other tumors, a number of studies have shown that it has good tolerance and efficacy. And a number of previous studies have shown that paclitaxel combined with platinum chemotherapy in the same period of head and neck cancer or nasopharyngeal cancer in multiple phase II clinical trials to achieve encouraging results. Based on the above background and basis, for the high risk (IVa-IVb) nasopharyngeal carcinoma treatment, the applicant intends to carry out the first IMRT + paclitaxel + DDP concurrent chemotherapy compared with DDP single drug concurrent chemotherapy regimen Pharyngeal cancer in a prospective randomized controlled phase Ⅱ clinical trial for paclitaxel + DDP dual-chemotherapy regimen for the treatment of high-risk nasopharyngeal carcinoma to provide evidence-based basis. (IVa-IVb) nasopharyngeal carcinoma (NPC), and to provide a high-level evidence-based evidence-based approach to the treatment of nasopharyngeal carcinoma at high risk (stage IVa-IVb). The results of this study will be used in international guidelines to optimize high- Treatment of cancer patients.

Official Title
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Phase II Randomized Trial Comparing Paclitaxel Combined With DDP Plus Concurrent Chemoradiotherapy With DDP Plus Concurrent Chemoradiotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Conditions
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Nasopharyngeal Carcinoma

Intervention / Treatment
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* Drug: Paclitaxel
* Drug: Cisplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with newly histologically confirmed non-keratinizing carcinoma. Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III. Original clinical staged as IVa-IVb（according to the 7th AJCC edition）. Male and no pregnant female Satisfactory performance status: ECOG (Eastern Cooperative OncologyGroup) scale 0-1. WBC ≥ 4×109 /L and PLT ≥4×109 /L and HGB ≥90 g/L With normal liver function test (ALT、AST ≤ 2.5×ULN, TBIL≤ 2.0×ULN) With normal renal function test (Creatinine ≤ 1.5×ULN) Written informed consent. Exclusion Criteria: Patients have evidence of relapse or distant metastasis Histologically confirmed keratinizing squamous cell carcinoma (WHO I) Receiving radiotherapy or chemotherapy previously The presence of uncontrolled life-threatening illness Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant. Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease). Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune competence may be less responsive to the experimental treatment and more susceptible to its toxicities). Concurrent systemic steroid therapy HIV positive Suffered from other malignant tumors (except the cure of basal cell carcinoma or uterine cervical carcinoma in situ) previously

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paclitaxel<br>Paclitaxel plus Cisplatin combine with IMRT | Drug: Paclitaxel<br>* Paclitaxel 135mg / m2 D1, DDP 20mg / m2 D1-4, D1,D29 of RT, a total of 2 courses.<br>* Other names: TAXOL;|
| Active Comparator: Cisplatin<br>Cisplatin combine with IMRT | Drug: Cisplatin<br>* Cisplatin 100mg / m2 , D1,D22,D43 of RT, a total of 3 courses.<br>* Other names: DDP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year progress free survival(PFS) | PFS means assignment to the date of any local or distant progress of the disease using Kaplan-Meier calculate the progress free survival rates,and find out is there significant difference between these two groups | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival(OS) | the overall survival denote to assignment to date of death from any cause. Using Kaplan-Meier to calculate the 2-year ,3-year,5-year overall survival rate,and find is there any significant difference between these two groups. | 2 years ,3 years and 5 years |