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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02937519
Other study ID # 2016080201
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date June 2015
Est. completion date June 2018

Study information

Verified date June 2018
Source Guiyang Medical University
Contact Hang Jiang, Bachelor degree
Phone 0851-86512802
Email 233956010@qq.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

1. Observe and compare the chrono-chemotherapy IMRT and conventional chemotherapy and intensity modulated radiotherapy term efficacy of the treatment of locally advanced nasopharyngeal carcinoma.

2. Evaluation chrono-chemotherapy IMRT and conventional chemotherapy and intensity modulated radiotherapy in locally advanced nasopharyngeal carcinoma safety and tolerability.

3)observing the adverse reaction and effects of two groups,expected chrono-chemotherapy group can achieve lower toxicity, improve the curative effect, for the treatment of nasopharyngeal carcinoma provides a more reasonable way.


Recruitment information / eligibility

Status Recruiting
Enrollment 160
Est. completion date June 2018
Est. primary completion date June 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- 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.

- 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:

- 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 ß-HCG test confirmed) or during lactation.

- serious complications, such as uncontrolled hypertension, heart failure, diabetes and so on.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Chrono-chemotherapy pump:Melodie

Routine intravenous drip

Drug:
induction Chrono-chemotherapy

induction Routine-chemotherapy

cisplatin chrono-chemotherapy

cisplatin routine-chemotherapy

Radiation:
intensity-modulated radiation therapy


Locations

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

Sponsors (3)

Lead Sponsor Collaborator
Guiyang Medical University Sun Yat-sen University, The Affiliated Cancer Hospital of Xiangya School of Medicine Central South University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants with curative effect Evaluate the immediate effect at 1year after Concurrent chemo-radiotherapy by RECIST. 1 year
Primary 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 3.0. 5 years
Secondary Progression-free survival Evaluate the Progression-free survival at five years after Concurrent chemo-radiotherapy by RECIST. 5 years
Secondary Overall survival Evaluate the Overall survival at five years after Concurrent chemo-radiotherapy by RECIST. 5 years
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