Back to resultsA Randomized Phase II Study of Concurrent Chemoradiation With Every 3 Week of Cisplatin vs With Weekly Cisplatin in Locally Advanced Nasopharyngeal Carcinoma
Primary Purpose
Nasophayngeal Carcinoma Between Stage II and IVb
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
cisplatin (3 weekly)
cisplatin (weekly)
Sponsored by
About this trial
This is an interventional treatment trial for Nasophayngeal Carcinoma Between Stage II and IVb
Eligibility Criteria
Inclusion Criteria:
- histologically confirmed nasopharyngeal carcinoma age of 18 years or over stage II ~ IVb no history of chemotherapy, radiotherapy, or immunotherapy for NPC with measurable lesion based on RECIST 1.1 ECOG PS 0 ~2 good organ function (liver, renal, hematologic)
Exclusion Criteria:
- active infectious disease requiring antibiotics uncontrolled heart disease pregnancy and on feeding state history of other malignancy within 5 years before enrollment, except for well treated non-melanomatous skin cancer, in situ cervical cancer, thyroid cancer
Sites / Locations
- Samsung Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
3 weekly CDDP based CCRT
weekly cisplatin based CCRT
Arm Description
radiation (conventioal or IMRT) with 3 cycles of 3-weekly cisplatin
radiation (conventional or IMRT) with 7 cycles of weekly cisplatin therapy
Outcomes
Primary Outcome Measures
progression free survival rate at 3 years
Secondary Outcome Measures
overall survival rate
objective response rate
toxicity
quality of life
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01171781
Brief Title
A Randomized Phase II Study of Concurrent Chemoradiation With Every 3 Week of Cisplatin vs With Weekly Cisplatin in Locally Advanced Nasopharyngeal Carcinoma
Official Title
A Randomized Phase II Study of Concurrent Chemoradiation With Every 3 Week of Cisplatin vs With Weekly Cisplatin in Locally Advanced Nasopharyngeal Carcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
June 2014 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Samsung Medical Center
4. Oversight
5. Study Description
Brief Summary
The study try to show the weekly cisplatin based CCRT is not inferior to 3-weekly cisplabe based CCRT in terms of 3-yr progression free survival rate in advanced nasopharyngeal carcinoma
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasophayngeal Carcinoma Between Stage II and IVb
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
3 weekly CDDP based CCRT
Arm Type
Active Comparator
Arm Description
radiation (conventioal or IMRT) with 3 cycles of 3-weekly cisplatin
Arm Title
weekly cisplatin based CCRT
Arm Type
Experimental
Arm Description
radiation (conventional or IMRT) with 7 cycles of weekly cisplatin therapy
Intervention Type
Drug
Intervention Name(s)
cisplatin (3 weekly)
Intervention Description
radiation with cisplatin (100mg/m2) on D1,D22,D43 and followed by adjuvant chemotherapy (3 cycles of FP)
Intervention Type
Drug
Intervention Name(s)
cisplatin (weekly)
Intervention Description
radiation with 7 cycles of cisplatin (40mg/m2) on D1,8,15,22,29,36,43, and followed by adjuvant chemothrapy (FP X3)
Primary Outcome Measure Information:
Title
progression free survival rate at 3 years
Time Frame
36 months
Secondary Outcome Measure Information:
Title
overall survival rate
Time Frame
36 months
Title
objective response rate
Time Frame
36 months
Title
toxicity
Time Frame
36 months
Title
quality of life
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
histologically confirmed nasopharyngeal carcinoma age of 18 years or over stage II ~ IVb no history of chemotherapy, radiotherapy, or immunotherapy for NPC with measurable lesion based on RECIST 1.1 ECOG PS 0 ~2 good organ function (liver, renal, hematologic)
Exclusion Criteria:
active infectious disease requiring antibiotics uncontrolled heart disease pregnancy and on feeding state history of other malignancy within 5 years before enrollment, except for well treated non-melanomatous skin cancer, in situ cervical cancer, thyroid cancer
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Myung-Ju Ahn, M.D, Ph.D.
Phone
822-3410-3438
Email
silkahn@skku.edu
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myung-Ju Ahn, M.D., Ph.D.
Phone
822-3410-3438
Email
silkahn@skku.edu
First Name & Middle Initial & Last Name & Degree
Myung-Ju Ahn, M.D., Ph.D.
12. IPD Sharing Statement
Learn more about this trial
A Randomized Phase II Study of Concurrent Chemoradiation With Every 3 Week of Cisplatin vs With Weekly Cisplatin in Locally Advanced Nasopharyngeal Carcinoma
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