Induction Chemotherapy Followed By Chrono-chemotherapy Concurrent With IMRT Of Locally Advanced NPC Clinical Study

Nasopharyngeal Carcinoma Clinical Trial

Official title:

Induction Chemotherapy Followed By Chrono-chemotherapy Concurrent With Intensity-modulated Radiotherapy In The Treatment Of Locally Advanced Nasopharyngeal Carcinoma PhaseⅡClinical Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02187315
• Other study ID #: 20140501
• Status: Recruiting
• Phase: Phase 2
• First received: May 15, 2014
• Last updated: July 10, 2014
• Start date: May 2014
• Est. completion date: December 2019

Study information

• Verified date: July 2014
• Source: Guiyang Medical College
• Contact: Feng Jin, Professor
• Phone: +86 13985124806
• Email: jinf8865[@]gmail.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Comparing induction chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy (chrono-chemotherapy group) with induction chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy (routine-chemotherapy group) in the treatment of locally advanced nasopharyngeal carcinoma, 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: December 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Pathological diagnosis of early cure ? - ? stage of patients with advanced nasopharyngeal carcinoma (according to the 2010 UICC staging criteria, T3-4, N0-3), no evidence of distant metastasis (M0). A measurable tumor lesions;

2. Karnofsky score=70;

3. Age 18-70 years old, male or female;

4. No major organ dysfunction; Normal bone marrow hematopoietic function (white blood cell =4.0×109/L,platelet=100×109 /L. hemoglobin =100g/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 the upper limit of normal) electrocardiogram does not affect the normal treatment;

5. To understand this study and sign informed consent form.

Exclusion Criteria:

1. A distant metastasis;

2. Patients with physical or mental illness, and researchers think that patients can't fully or adequately understand the possible complications of this study;

3. Pregnancy (confirmed by serum or urine ß-HCG test) or between lactation period;

4. Serious complications, such as uncontrollable hypertension, heart function failure, diabetes, etc.; 5.Who had received radiation and chemotherapy.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nasopharyngeal Carcinoma
• Nasopharyngeal Neoplasms

Intervention

Device:
• Chrono-chemotherapy pump:Melodie

• Routine intravenous drip

Drug:
• induction chemotherapy

• cisplatin chrono-chemotherapy

Radiation:
• intensity-modulated radiation therapy

Drug:
• cisplatin routine-chemotherapy

Locations

Country	Name	City	State
China	The Affiliated Hospital of Guiyang Medical College/The Affiliated Cancer Hospital of Guiyang Medical College/Guizhou Cancer Hospital	Guiyang	Guizhou

Sponsors (1)

Lead Sponsor	Collaborator
Feng Jing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events as a Measure of Safety		5 year	Yes
Secondary	Number of Participants with curative effect		1 year	No