the Study of Effect of Chronomodulated Chemotherapy on the Dendritic Cells Subsets in the Treatment of Advanced Nasopharyngeal Cancer

Study Overview
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Brief Summary
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This study is to observe and compare the effect of docetaxel plus lobaplatin induction chemotherapy combined with lopoplatin chemoradiotherapy and TPF induction chemotherapy combined with cisplatin chemoradiotherapy on dendritic cells subsets in the treatment of locally advanced head and neck squamous cell carcinoma.

Detailed Description
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TPF program is currently the local advanced head and neck squamous cell carcinoma commonly used inducing chemotherapy, cisplatin is the preferred drug for the same period chemotherapy.Dendritic cells (DC) play an essential role in the induction and regulation of immune responses.The effect of radiation and chemotherapy is closely related to the patients' immune function.In this study, Phase II clinical trials were performed. Patients with locally advanced head and neck squamous cell carcinoma were randomly divided into experimental group and control group. The trial group was treated with docetaxel + lorosine-induced chemotherapy combined with lorplatin concurrent radiotherapy and chemotherapy. The control group was treated with TPF Cisplatin concurrent chemotherapy, observed the relationship between dendritic cells subsets and clinical prognosis of patients, to provide a new method for the treatment of locally advanced nasopharyngeal carcinoma and technical support

Official Title
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Phase II Clinical Randomized Study of the Effect of Chronomodulated Chemotherapy Followed by Concurrent IMRT Chemo-radiotherapy on the Dendritic Cells Subsets and Immunity in the Treatment of Advanced Nasopharyngeal Cancer

Conditions
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Locally Advanced Head and Neck Squamous Cell Carcinoma

Intervention / Treatment
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* Device: Chrono-chemotherapy
* Device: Routine intravenous drip
* Drug: induction Chrono-chemotherapy
* Drug: induction Routine-chemotherapy
* Drug: cisplatin chrono-chemotherapy
* Drug: cisplatin routine-chemotherapy
* Radiation: intensity-modulated radiation therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: initial treatment of advanced nasopharyngeal carcinoma Ⅲ-Ⅳ patients with pathologically confirmed (according to 2010 UICC staging, T3-4, N0-3), without evidence of distant metastasis (M0). Have measurable tumor lesions. KPS≥70 points. the age of 18-70 years old, male or female. no major organ dysfunction; normal bone marrow function (WBC ≥4.0 × 109 / L, platelets ≥100 × 109 / L, hemoglobin ≥90g / L), normal liver function (total bilirubin, alanine aminotransferase, aspartate aminotransferase ≤1.5 times the upper limit of normal), normal renal function (creatinine ≤ 1.5 times upper limit of normal). understand this study and signed informed consent Exclusion Criteria: Three months in the use of Chinese herbal medicine or immune modulators distant metastasis. who had received prior chemotherapy. patients have physical or mental illness, and by researchers believe that patients can not be completely or fully understood in this study possible complications. pregnancy (via the urine or serum β-HCG test confirmed) or during lactation. serious complications, such as uncontrolled hypertension, heart failure, diabetes and so on.

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: Chrono-chemotherapy group<br>Induction chrono-chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy;Delivery time is different from the control group | Device: Chrono-chemotherapy<br>* Chrono-chemotherapy+concurrent radiochemotherapy<br>* Other names: Experimental group;Drug: induction Chrono-chemotherapy<br>* Experimental group:docetaxel,cisplatin,5-FU<br>* Other names: chronological dosage;Drug: cisplatin chrono-chemotherapy<br>* Experimental group: cisplatin chrono-chemotherapy<br>* Other names: cisplatin Conventional drug delivery;Radiation: intensity-modulated radiation therapy<br>* control group is similar to Experimental group<br>|
| Other: Routine intravenous drip<br>control group:Induction routine-chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy | Device: Routine intravenous drip<br>* Routine intravenous drip-chemotherap<br>* Other names: control group;Drug: induction Routine-chemotherapy<br>* control group:docetaxel,cisplatin,5-FU<br>* Other names: Conventional drug delivery;Drug: cisplatin routine-chemotherapy<br>* control group:cisplatin routine-chemotherapy<br>* Other names: cisplatin Conventional drug delivery;Radiation: intensity-modulated radiation therapy<br>* control group is similar to Experimental group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dendritic cell subgroup changes of Participants | By flow cytometry detection of two groups of peripheral blood dendritic cells subsets and lymphocyte subpopulation changes before and after the radiation and chemotherapy | termination of treatment, 3 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with curative effect | Evaluate the immediate effect at 1year after Concurrent chemo-radiotherapy by RECIST | 1 year | 
| Number of Participants with Adverse Events as a Measure of Safety | To assess and record nausea, vomiting, oral mucositis, diarrhea and other adverse drug reactions by CTC 4.0 | 5 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NPC peripheral blood dendritic cell chronic-chemotherap