A Randomized Phase II Study of Concurrent Chemoradiation With Every 3 Week of Cisplatin vs With Weekly Cisplatin in Locally Advanced Nasopharyngeal Carcinoma
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Nasophayngeal Carcinoma Between Stage II and IVb
Both
Nasophayngeal Carcinoma Between Stage II and IVb
Trial Information
A Randomized Phase II Study of Concurrent Chemoradiation With Every 3 Week of Cisplatin vs With Weekly Cisplatin in Locally Advanced Nasopharyngeal Carcinoma
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
progression free survival rate at 3 years
Outcome Time Frame:
36 months
Safety Issue:
No
Authority:
Korea: Food and Drug Administration
Study ID:
2009-09-037
NCT ID:
NCT01171781
Start Date:
November 2009
Completion Date:
June 2014
Related Keywords:
- Nasophayngeal Carcinoma Between Stage II and IVb
- Carcinoma
- Nasopharyngeal Neoplasms
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