Status:
UNKNOWN
A Randomized Phase II Study of Concurrent Chemoradiation With Every 3 Week of Cisplatin vs With Weekly Cisplatin in Locally Advanced Nasopharyngeal Carcinoma
Lead Sponsor:
Samsung Medical Center
Conditions:
Nasophayngeal Carcinoma Between Stage II and IVb
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2014
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT01171781
Start Date
November 1 2009
End Date
June 1 2014
Last Update
July 28 2010
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea, 135-710