Back to resultsInduction Chemotherapy Followed By Chrono-chemotherapy Concurrent With IMRT Of Locally Advanced NPC Clinical Study
Primary Purpose
Nasopharyngeal Carcinoma
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Chrono-chemotherapy pump:Melodie
Routine intravenous drip
induction chemotherapy
cisplatin chrono-chemotherapy
intensity-modulated radiation therapy
cisplatin routine-chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Nasopharyngeal Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Pathological diagnosis of early cure Ⅲ - Ⅳ 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;
- Karnofsky score≥70;
- Age 18-70 years old, male or female;
- 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;
- To understand this study and sign informed consent form.
Exclusion Criteria:
- A distant metastasis;
- Patients with physical or mental illness, and researchers think that patients can't fully or adequately understand the possible complications of this study;
- Pregnancy (confirmed by serum or urine β-HCG test) or between lactation period;
- Serious complications, such as uncontrollable hypertension, heart function failure, diabetes, etc.; 5.Who had received radiation and chemotherapy.
Sites / Locations
- The Affiliated Hospital of Guiyang Medical College/The Affiliated Cancer Hospital of Guiyang Medical College/Guizhou Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Melodie group
Routine-chemotherapy group
Arm Description
Induction chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy
Induction chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy
Outcomes
Primary Outcome Measures
Number of Participants with Adverse Events as a Measure of Safety
Secondary Outcome Measures
Number of Participants with curative effect
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02187315
Brief Title
Induction Chemotherapy Followed By Chrono-chemotherapy Concurrent With IMRT Of Locally Advanced NPC Clinical Study
Official Title
Induction Chemotherapy Followed By Chrono-chemotherapy Concurrent With Intensity-modulated Radiotherapy In The Treatment Of Locally Advanced Nasopharyngeal Carcinoma PhaseⅡClinical Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Feng Jing
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Melodie group
Arm Type
Experimental
Arm Description
Induction chemotherapy followed by cisplatin chrono-chemotherapy concurrent combined with intensity-modulated radiation therapy
Arm Title
Routine-chemotherapy group
Arm Type
Other
Arm Description
Induction chemotherapy followed by cisplatin routine-chemotherapy concurrent combined with intensity-modulated radiation therapy
Intervention Type
Device
Intervention Name(s)
Chrono-chemotherapy pump:Melodie
Intervention Type
Device
Intervention Name(s)
Routine intravenous drip
Intervention Type
Drug
Intervention Name(s)
induction chemotherapy
Intervention Type
Drug
Intervention Name(s)
cisplatin chrono-chemotherapy
Intervention Type
Radiation
Intervention Name(s)
intensity-modulated radiation therapy
Intervention Type
Drug
Intervention Name(s)
cisplatin routine-chemotherapy
Primary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety
Time Frame
5 year
Secondary Outcome Measure Information:
Title
Number of Participants with curative effect
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Pathological diagnosis of early cure Ⅲ - Ⅳ 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;
Karnofsky score≥70;
Age 18-70 years old, male or female;
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;
To understand this study and sign informed consent form.
Exclusion Criteria:
A distant metastasis;
Patients with physical or mental illness, and researchers think that patients can't fully or adequately understand the possible complications of this study;
Pregnancy (confirmed by serum or urine β-HCG test) or between lactation period;
Serious complications, such as uncontrollable hypertension, heart function failure, diabetes, etc.; 5.Who had received radiation and chemotherapy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feng Jin, Professor
Phone
+86 13985124806
Email
jinf8865@gmail.com
Facility Information:
Facility Name
The Affiliated Hospital of Guiyang Medical College/The Affiliated Cancer Hospital of Guiyang Medical College/Guizhou Cancer Hospital
City
Guiyang
State/Province
Guizhou
ZIP/Postal Code
550001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Feng Jin, Professor
Phone
+86 13985124806
Email
jinf8865@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Induction Chemotherapy Followed By Chrono-chemotherapy Concurrent With IMRT Of Locally Advanced NPC Clinical Study
We'll reach out to this number within 24 hrs