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

NCT03196869 | Unknown Phase 2 DMC

• 1 other identifier: 201708112121
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced Head and Neck Squamous Cell Carcinoma

Keywords

NPC peripheral blood dendritic cell chronic-chemotherap

Outcome Measures

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

  termination of treatment, 3 months after treatment

Secondary Outcomes (2)

• Number of Participants with curative effect

  1 year

• Number of Participants with Adverse Events as a Measure of Safety

  5 year

Other Outcomes (2)

• Progression-free survival

  5 years

• Overall survival

  5 years

Study Arms (2)

Chrono-chemotherapy group

EXPERIMENTAL

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

Routine intravenous drip

OTHER

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

Chrono-chemotherapy DEVICE

Chrono-chemotherapy+concurrent radiochemotherapy

Also known as: Experimental group

Chrono-chemotherapy group

Routine intravenous drip DEVICE

Routine intravenous drip-chemotherap

Also known as: control group

Routine intravenous drip

induction Chrono-chemotherapy DRUG

Experimental group:docetaxel,cisplatin,5-FU

Also known as: chronological dosage

Chrono-chemotherapy group

induction Routine-chemotherapy DRUG

control group:docetaxel,cisplatin,5-FU

Also known as: Conventional drug delivery

Routine intravenous drip

cisplatin chrono-chemotherapy DRUG

Experimental group: cisplatin chrono-chemotherapy

Also known as: cisplatin Conventional drug delivery

Chrono-chemotherapy group

cisplatin routine-chemotherapy DRUG

control group:cisplatin routine-chemotherapy

Also known as: cisplatin Conventional drug delivery

Routine intravenous drip

intensity-modulated radiation therapy RADIATION

control group is similar to Experimental group

Chrono-chemotherapy group; Routine intravenous drip

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guiyang Medical University: lead

Study Sites (1)

Cancer Hospital of Guizhou Medical University

Guiyang, Guizhou, 550000, China

RECRUITING

MeSH Terms

Interventions

Control Groups; Radiotherapy, Intensity-Modulated

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Feng Jin, Bachelor

  Guizhou Provincial Cancer Hospital

  STUDY CHAIR

Central Study Contacts

Feng Jin, Bachelor

CONTACT

0851-86512802; jinf8865@yeah.net

Juan Li, Bachelor

CONTACT

0851-86512802; 1348330985@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head and neck cancer director, chief researcher, clinical professor

Study Record Dates

• First Submitted: June 21, 2017
• First Posted: June 23, 2017
• Study Start: April 7, 2017
• Primary Completion: April 12, 2019
• Study Completion: August 12, 2022
• Last Updated: June 23, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)