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
- Conditions
- Nasophayngeal Carcinoma Between Stage II and IVb
- Interventions
- Registration Number
- NCT01171781
- Lead Sponsor
- Samsung Medical Center
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 110
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 weekly CDDP based CCRT cisplatin (3 weekly) radiation (conventioal or IMRT) with 3 cycles of 3-weekly cisplatin weekly cisplatin based CCRT cisplatin (weekly) radiation (conventional or IMRT) with 7 cycles of weekly cisplatin therapy
- Primary Outcome Measures
Name Time Method progression free survival rate at 3 years 36 months
- Secondary Outcome Measures
Name Time Method overall survival rate 36 months objective response rate 36 months toxicity 36 months quality of life 36 months
Trial Locations
- Locations (1)
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of