Nasophayngeal Carcinoma Between Stage II and IVb
Conditions
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
Interventions
DRUGcisplatin (3 weekly)
radiation with cisplatin (100mg/m2) on D1,D22,D43 and followed by adjuvant chemotherapy (3 cycles of FP)
DRUGcisplatin (weekly)
radiation with 7 cycles of cisplatin (40mg/m2) on D1,8,15,22,29,36,43, and followed by adjuvant chemothrapy (FP X3)
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival rate at 3 years | 36 months |
Secondary
| Measure | Time frame |
|---|---|
| overall survival rate | 36 months |
| objective response rate | 36 months |
| toxicity | 36 months |
| quality of life | 36 months |
Countries
South Korea
Contacts
Primary ContactMyung-Ju Ahn, M.D, Ph.D.
Outcome results
None listed