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Status unknownNCT03196869Updated Jun 23, 2017

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

A Phase 2 interventional study of Chrono-chemotherapy and Routine intravenous drip in Locally Advanced Head and Neck Squamous Cell Carcinoma, sponsored by Guiyang Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-06-23.

Sponsored by Guiyang Medical University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
128
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Locally Advanced Head and Neck Squamous Cell Carcinoma

Keywords

  • NPC peripheral blood dendritic cell chronic-chemotherap
03

In context

Squamous Cell Carcinoma of Head and Neck

1,680 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 539 are open to participants now.

This study's planned enrollment of 128 is above the median of 49 across 1,432 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.

Browse Squamous Cell Carcinoma of Head and Neck studies →

Lead sponsor

Guiyang Medical University is the lead sponsor of 9 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
128 participants (estimated)

Study arms

  • 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 · Drug: induction Chrono-chemotherapy · Drug: cisplatin chrono-chemotherapy · Radiation: intensity-modulated radiation therapy

  • Other
    Routine intravenous drip

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

    Device: Routine intravenous drip · Drug: induction Routine-chemotherapy · Drug: cisplatin routine-chemotherapy · Radiation: intensity-modulated radiation therapy

Interventions

  • DeviceChrono-chemotherapy

    Chrono-chemotherapy+concurrent radiochemotherapy

    Also known as: Experimental group

  • DeviceRoutine intravenous drip

    Routine intravenous drip-chemotherap

    Also known as: control group

  • Druginduction Chrono-chemotherapy

    Experimental group:docetaxel,cisplatin,5-FU

    Also known as: chronological dosage

  • Druginduction Routine-chemotherapy

    control group:docetaxel,cisplatin,5-FU

    Also known as: Conventional drug delivery

  • Drugcisplatin chrono-chemotherapy

    Experimental group: cisplatin chrono-chemotherapy

    Also known as: cisplatin Conventional drug delivery

  • Drugcisplatin routine-chemotherapy

    control group:cisplatin routine-chemotherapy

    Also known as: cisplatin Conventional drug delivery

  • Radiationintensity-modulated radiation therapy

    control group is similar to Experimental group

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: termination of treatment, 3 months after treatment

Secondary outcomes

  1. Number of Participants with curative effect

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

    Time frame: 1 year

  2. 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

    Time frame: 5 year

Other outcomes

  1. Progression-free survival

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

    Time frame: 5 years

  2. Overall survival

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

    Time frame: 5 years

07

Study locations

1 of 1 sites recruiting
  • Cancer Hospital of Guizhou Medical University
    Guiyang, Guizhou 550000, China
    • Feng Jin, Bachelor · Contact · jinf8865@yahoo.com.cn · 0851-86512802
    • Weili Wu, master · Sub investigator
    • Jinhua Long, master · Sub investigator
    • Yuanyuan Li, master · Sub investigator
    • Xiuyun Gong, Bachelor · Sub investigator
    • Xiaoxiao Chen, Bachelor · Sub investigator
    • Juan Li, Bachelor · Sub investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03196869
Lead sponsor
Guiyang Medical University
Responsible party
Feng Jing (Head and neck cancer director, chief researcher, clinical professor, Guiyang Medical University) — Principal investigator
First posted
Jun 23, 2017
Start date
Apr 7, 2017
Primary completion
Apr 12, 2019 (estimated)
Completion
Aug 12, 2022 (estimated)
Last update
Jun 23, 2017

Study contacts

Feng Jin, Bachelor
Contact
jinf8865@yeah.net
0851-86512802
Juan Li, Bachelor
Contact
1348330985@qq.com
0851-86512802
Feng Jin, Bachelor
study chair · Guizhou Provincial Cancer Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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