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

June 21, 2017 updated by: Feng Jing, Guiyang Medical University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

128

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guizhou
      • Guiyang, Guizhou, China, 550000
        • Recruiting
        • Cancer Hospital of Guizhou Medical University
        • Contact:
        • Sub-Investigator:
          • Juan Li, Bachelor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Chrono-chemotherapy group
Induction chrono-chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy;Delivery time is different from the control group
Device: Chrono-chemotherapy
Chrono-chemotherapy+concurrent radiochemotherapy
Other Names:
  • Experimental group
Drug: induction Chrono-chemotherapy
Experimental group:docetaxel,cisplatin,5-FU
Other Names:
  • chronological dosage
Drug: cisplatin chrono-chemotherapy
Experimental group: cisplatin chrono-chemotherapy
Other Names:
  • cisplatin Conventional drug delivery
Radiation: intensity-modulated radiation therapy
control group is similar to Experimental group
OTHER: Routine intravenous drip
control group:Induction routine-chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy
Radiation: intensity-modulated radiation therapy
control group is similar to Experimental group
Device: Routine intravenous drip
Routine intravenous drip-chemotherap
Other Names:
  • control group
Drug: induction Routine-chemotherapy
control group:docetaxel,cisplatin,5-FU
Other Names:
  • Conventional drug delivery
Drug: cisplatin routine-chemotherapy
control group:cisplatin routine-chemotherapy
Other Names:
  • cisplatin Conventional drug delivery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dendritic cell subgroup changes of Participants
Time Frame: 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
termination of treatment, 3 months after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with curative effect
Time Frame: 1 year
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
Time Frame: 5 year
To assess and record nausea, vomiting, oral mucositis, diarrhea and other adverse drug reactions by CTC 4.0
5 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival
Time Frame: 5 years
Evaluate the Progression-free survival at five years after Concurrent chemo-radiotherapy by RECIST.
5 years
Overall survival
Time Frame: 5 years
Evaluate the Overall survival at five years after Concurrent chemo-radiotherapy by RECIST
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guiyang Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 7, 2017

Primary Completion (ANTICIPATED)

April 12, 2019

Study Completion (ANTICIPATED)

August 12, 2022

Study Registration Dates

First Submitted

June 21, 2017

First Submitted That Met QC Criteria

June 21, 2017

First Posted (ACTUAL)

June 23, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 23, 2017

Last Update Submitted That Met QC Criteria

June 21, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201708112121

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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