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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chrono-chemotherapy group | Experimental | Induction chrono-chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy;Delivery time is different from the control group |
|
| Routine intravenous drip | Other | control group:Induction routine-chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chrono-chemotherapy | Device | Chrono-chemotherapy+concurrent radiochemotherapy |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Evaluate the Progression-free survival at five years after Concurrent chemo-radiotherapy by RECIST. | 5 years |
| Overall survival | Evaluate the Overall survival at five years after Concurrent chemo-radiotherapy by RECIST |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Feng Jin, Bachelor | Contact | 0851-86512802 | jinf8865@yeah.net | |
| Juan Li, Bachelor | Contact | 0851-86512802 | 1348330985@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Feng Jin, Bachelor | Guizhou Provincial Cancer Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital of Guizhou Medical University | Recruiting | Guiyang | Guizhou | 550000 | China |
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| Routine intravenous drip | Device | Routine intravenous drip-chemotherap |
|
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| induction Chrono-chemotherapy | Drug | Experimental group:docetaxel,cisplatin,5-FU |
|
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| induction Routine-chemotherapy | Drug | control group:docetaxel,cisplatin,5-FU |
|
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| cisplatin chrono-chemotherapy | Drug | Experimental group: cisplatin chrono-chemotherapy |
|
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| cisplatin routine-chemotherapy | Drug | control group:cisplatin routine-chemotherapy |
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| intensity-modulated radiation therapy | Radiation | control group is similar to Experimental group |
|
To assess and record nausea, vomiting, oral mucositis, diarrhea and other adverse drug reactions by CTC 4.0
| 5 year |
| 5 years |
| ID | Term |
|---|---|
| D035061 | Control Groups |
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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