Back to resultsDifferent Chemotherapy Protocols Combined With Intensity Modulated Radiation Therapy in Patients With Locally Advanced Nasopharyngeal Carcinoma
Primary Purpose
Drug-Related Side Effects and Adverse Reactions
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Cisplatin
Docetaxel
Sponsored by
About this trial
This is an interventional treatment trial for Drug-Related Side Effects and Adverse Reactions focused on measuring locally advanced nasopharyngeal carcinoma, Concurrent chemoradiotherapy, Toxic reaction
Eligibility Criteria
Inclusion Criteria:
- Patients > 18, <70 years old, with locally advanced nasopharyngeal carcinoma.
Exclusion Criteria:
- patients who had accepted radiotherapy before patients with any ather types of cancer
Sites / Locations
- Chinese PLA general hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Docetaxel
Cisplatin
DocetaxelCisplatin
Arm Description
Cisplatin combined with Docetaxel
Outcomes
Primary Outcome Measures
changes in toxic reaction
incidence rate of the toxic reaction between three groups
Secondary Outcome Measures
over survival
differences of over survival rate between three groups
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03177174
Brief Title
Different Chemotherapy Protocols Combined With Intensity Modulated Radiation Therapy in Patients With Locally Advanced Nasopharyngeal Carcinoma
Official Title
the General Hospital of PLA
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
June 12, 2017 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
February 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Luo yanrong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study was to evaluate the efficacy ,toxic reaction and safety of different chemotherapy combined with radiotherapy on patients with locally advanced nasopharyngeal carcinoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug-Related Side Effects and Adverse Reactions
Keywords
locally advanced nasopharyngeal carcinoma, Concurrent chemoradiotherapy, Toxic reaction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Docetaxel
Arm Type
Active Comparator
Arm Title
Cisplatin
Arm Type
Active Comparator
Arm Title
DocetaxelCisplatin
Arm Type
Active Comparator
Arm Description
Cisplatin combined with Docetaxel
Intervention Type
Drug
Intervention Name(s)
Cisplatin
Intervention Description
radiotherapy combined with Chemotherapy Drugs, Cancer
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
Docetaxel
Primary Outcome Measure Information:
Title
changes in toxic reaction
Description
incidence rate of the toxic reaction between three groups
Time Frame
5 years
Secondary Outcome Measure Information:
Title
over survival
Description
differences of over survival rate between three groups
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients > 18, <70 years old, with locally advanced nasopharyngeal carcinoma.
Exclusion Criteria:
patients who had accepted radiotherapy before patients with any ather types of cancer
Facility Information:
Facility Name
Chinese PLA general hospital
City
Beijing
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35770295
Citation
Luo Y, Cai B, Li B, Liu F, Du L, Zhao D, Fan W, Meng L, Zhang X, Ma L. The Acute Toxicities and Efficacy of Concurrent Chemotherapy With Docetaxel Plus Cisplatin, or Docetaxel, or Cisplatin and Helical Tomotherapy in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma: A Randomized Single-Center Phase II Trial. Technol Cancer Res Treat. 2022 Jan-Dec;21:15330338221109974. doi: 10.1177/15330338221109974.
Results Reference
derived
Learn more about this trial
Different Chemotherapy Protocols Combined With Intensity Modulated Radiation Therapy in Patients With Locally Advanced Nasopharyngeal Carcinoma
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