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

Primary Purpose

Locally Advanced Head and Neck Squamous Cell Carcinoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Chrono-chemotherapy

Routine intravenous drip

induction Chrono-chemotherapy

induction Routine-chemotherapy

cisplatin chrono-chemotherapy

cisplatin routine-chemotherapy

intensity-modulated radiation therapy

About this trial

This is an interventional treatment trial for Locally Advanced Head and Neck Squamous Cell Carcinoma focused on measuring NPC peripheral blood dendritic cell chronic-chemotherap

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Cancer Hospital of Guizhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Chrono-chemotherapy group

Routine intravenous drip

Arm Description

Induction chrono-chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy;Delivery time is different from the control group

control group:Induction routine-chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Participants with curative effect

Evaluate the immediate effect at 1year after Concurrent chemo-radiotherapy by RECIST

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

Full Information

NCT ID

NCT03196869

First Posted

June 21, 2017

Last Updated

June 21, 2017

Sponsor

Guiyang Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03196869

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Unknown status

Study Start Date

April 7, 2017 (Actual)

Primary Completion Date

April 12, 2019 (Anticipated)

Study Completion Date

August 12, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guiyang Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Locally Advanced Head and Neck Squamous Cell Carcinoma

Keywords

NPC peripheral blood dendritic cell chronic-chemotherap

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Chrono-chemotherapy group

Arm Type

Experimental

Arm Description

Induction chrono-chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy;Delivery time is different from the control group

Arm Title

Routine intravenous drip

Arm Type

Other

Arm Description

control group:Induction routine-chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy

Intervention Type

Device

Intervention Name(s)

Chrono-chemotherapy

Other Intervention Name(s)

Experimental group

Intervention Description

Chrono-chemotherapy+concurrent radiochemotherapy

Intervention Type

Device

Intervention Name(s)

Routine intravenous drip

Other Intervention Name(s)

control group

Intervention Description

Routine intravenous drip-chemotherap

Intervention Type

Drug

Intervention Name(s)

induction Chrono-chemotherapy

Other Intervention Name(s)

chronological dosage

Intervention Description

Experimental group:docetaxel,cisplatin,5-FU

Intervention Type

Drug

Intervention Name(s)

induction Routine-chemotherapy

Other Intervention Name(s)

Conventional drug delivery

Intervention Description

control group:docetaxel,cisplatin,5-FU

Intervention Type

Drug

Intervention Name(s)

cisplatin chrono-chemotherapy

Other Intervention Name(s)

cisplatin Conventional drug delivery

Intervention Description

Experimental group: cisplatin chrono-chemotherapy

Intervention Type

Drug

Intervention Name(s)

cisplatin routine-chemotherapy

Other Intervention Name(s)

cisplatin Conventional drug delivery

Intervention Description

control group:cisplatin routine-chemotherapy

Intervention Type

Radiation

Intervention Name(s)

intensity-modulated radiation therapy

Intervention Description

control group is similar to Experimental group

Primary Outcome Measure Information:

Title

Dendritic cell subgroup changes of Participants

Description

By flow cytometry detection of two groups of peripheral blood dendritic cells subsets and lymphocyte subpopulation changes before and after the radiation and chemotherapy

Time Frame

termination of treatment, 3 months after treatment

Secondary Outcome Measure Information:

Title

Number of Participants with curative effect

Description

Evaluate the immediate effect at 1year after Concurrent chemo-radiotherapy by RECIST

Time Frame

1 year

Title

Number of Participants with Adverse Events as a Measure of Safety

Description

To assess and record nausea, vomiting, oral mucositis, diarrhea and other adverse drug reactions by CTC 4.0

Time Frame

5 year

Other Pre-specified Outcome Measures:

Title

Progression-free survival

Description

Evaluate the Progression-free survival at five years after Concurrent chemo-radiotherapy by RECIST.

Time Frame

5 years

Title

Overall survival

Description

Evaluate the Overall survival at five years after Concurrent chemo-radiotherapy by RECIST

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Feng Jin, Bachelor

Phone

0851-86512802

jinf8865@yeah.net

First Name & Middle Initial & Last Name or Official Title & Degree

Juan Li, Bachelor

Phone

0851-86512802

1348330985@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Feng Jin, Bachelor

Organizational Affiliation

Guizhou Provincial Cancer Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Cancer Hospital of Guizhou Medical University

City

Guiyang

State/Province

Guizhou

ZIP/Postal Code

550000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Feng Jin, Bachelor

Phone

0851-86512802

jinf8865@yahoo.com.cn

First Name & Middle Initial & Last Name & Degree

Weili Wu, master

First Name & Middle Initial & Last Name & Degree

Jinhua Long, master

First Name & Middle Initial & Last Name & Degree

Yuanyuan Li, master

First Name & Middle Initial & Last Name & Degree

Xiuyun Gong, Bachelor

First Name & Middle Initial & Last Name & Degree

Xiaoxiao Chen, Bachelor

First Name & Middle Initial & Last Name & Degree

Juan Li, Bachelor

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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