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

Locally Advanced Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03196869
• Other study ID #: 201708112121
• Status: Recruiting
• Phase: Phase 2
• First received: June 21, 2017
• Last updated: June 21, 2017
• Start date: April 7, 2017
• Est. completion date: August 12, 2022

Study information

• Verified date: June 2017
• Source: Guiyang Medical University
• Contact: Feng Jin, Bachelor
• Phone: 0851-86512802
• Email: jinf8865[@]yeah.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: August 12, 2022
• Est. primary completion date: April 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. initial treatment of advanced nasopharyngeal carcinoma ?-? 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 ß-HCG test confirmed) or during lactation. serious complications, such as uncontrolled hypertension, heart failure, diabetes and so on.

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Head and Neck Neoplasms
• Locally Advanced Head and Neck Squamous Cell Carcinoma
• Nasopharyngeal Neoplasms

Intervention

Device:
• Chrono-chemotherapy
Chrono-chemotherapy+concurrent radiochemotherapy
• Routine intravenous drip
Routine intravenous drip-chemotherap

Drug:
• induction Chrono-chemotherapy
Experimental group:docetaxel,cisplatin,5-FU
• induction Routine-chemotherapy
control group:docetaxel,cisplatin,5-FU
• cisplatin chrono-chemotherapy
Experimental group: cisplatin chrono-chemotherapy
• cisplatin routine-chemotherapy
control group:cisplatin routine-chemotherapy

Radiation:
• intensity-modulated radiation therapy
control group is similar to Experimental group

Locations

Country	Name	City	State
China	Cancer Hospital of Guizhou Medical University	Guiyang	Guizhou

Sponsors (1)

Lead Sponsor	Collaborator
Guiyang Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Progression-free survival	Evaluate the Progression-free survival at five years after Concurrent chemo-radiotherapy by RECIST.	5 years
Other	Overall survival	Evaluate the Overall survival at five years after Concurrent chemo-radiotherapy by RECIST	5 years
Primary	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	Number of Participants with curative effect	Evaluate the immediate effect at 1year after Concurrent chemo-radiotherapy by RECIST	1 year
Secondary	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