the Study of Effect of Chronomodulated Chemotherapy on the Dendritic Cells Subsets in the Treatment of Advanced Nasopharyngeal Cancer
- Conditions
- Locally Advanced Head and Neck Squamous Cell Carcinoma
- Interventions
- Device: Chrono-chemotherapyDevice: Routine intravenous dripDrug: induction Routine-chemotherapyDrug: induction Chrono-chemotherapyRadiation: intensity-modulated radiation therapy
- Registration Number
- NCT03196869
- Lead Sponsor
- Guiyang Medical University
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 128
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Chrono-chemotherapy group Chrono-chemotherapy Induction chrono-chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy;Delivery time is different from the control group Chrono-chemotherapy group intensity-modulated radiation therapy 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 Routine intravenous drip control group:Induction routine-chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy Routine intravenous drip induction Routine-chemotherapy control group:Induction routine-chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy Routine intravenous drip intensity-modulated radiation therapy control group:Induction routine-chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy Chrono-chemotherapy group induction Chrono-chemotherapy Induction chrono-chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy;Delivery time is different from the control group Chrono-chemotherapy group cisplatin chrono-chemotherapy 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 cisplatin routine-chemotherapy control group:Induction routine-chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Cancer Hospital of Guizhou Medical University
🇨🇳Guiyang, Guizhou, China