Locally Advanced Head and Neck Squamous Cell Carcinoma
Conditions
Keywords
NPC peripheral blood dendritic cell chronic-chemotherap
Brief summary
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
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
Interventions
DEVICEChrono-chemotherapy
Chrono-chemotherapy+concurrent radiochemotherapy
DEVICERoutine intravenous drip
Routine intravenous drip-chemotherap
Experimental group:docetaxel,cisplatin,5-FU
control group:docetaxel,cisplatin,5-FU
Experimental group: cisplatin chrono-chemotherapy
control group:cisplatin routine-chemotherapy
RADIATIONintensity-modulated radiation therapy
control group is similar to Experimental group
Sponsors
Guiyang Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. 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. 2. KPS≥70 points. 3. the age of 18-70 years old, male or female. 4. 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). 5. understand this study and signed informed consent
Exclusion criteria
1. Three months in the use of Chinese herbal medicine or immune modulators 2. distant metastasis. 3. who had received prior chemotherapy. 4. patients have physical or mental illness, and by researchers believe that patients can not be completely or fully understood in this study possible complications. 5. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dendritic cell subgroup changes of Participants | termination of treatment, 3 months after treatment | By flow cytometry detection of two groups of peripheral blood dendritic cells subsets and lymphocyte subpopulation changes before and after the radiation and chemotherapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with curative effect | 1 year | Evaluate the immediate effect at 1year after Concurrent chemo-radiotherapy by RECIST |
| Number of Participants with Adverse Events as a Measure of Safety | 5 year | To assess and record nausea, vomiting, oral mucositis, diarrhea and other adverse drug reactions by CTC 4.0 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | 5 years | Evaluate the Progression-free survival at five years after Concurrent chemo-radiotherapy by RECIST. |
| Overall survival | 5 years | Evaluate the Overall survival at five years after Concurrent chemo-radiotherapy by RECIST |
Countries
China
Contacts
Primary ContactFeng Jin, Bachelor
Backup ContactJuan Li, Bachelor
Outcome results
None listed