This study is to evaluate the efficacy and safety of radiotherapy combined with GDP (gemcitabine, cisplatin, dexamethasone) chemotherapy in stage I/II extranodal natural killer/T-cell lymphoma patients with unfavorable prognostic factors.
Radiotherapy has been recognized as the definitive treatment of choice for stages I and II extranodal NK/T cell lymphoma. The progression-free survival rate and overall survival rate of radiotherapy plus anthracycline-containing chemotherapy were comparable to that of radiotherapy alone. Our previous studies demonstrated the high responsiveness and safety of GDP (gemcitabine, cisplatin, dexamethasone) regimen in patients with extranodal NK/T cell lymphoma. Therefore, we design this study to evaluate the safety and benefit of radiotherapy plus GDP regimen in extranodal NK/T cell lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
total dose: 50 to 56 grays per fraction: 2 grays
gemcitabine (1000mg/m2 intravenously over 30 minutes on days 1 and 8), cisplatin (25mg/m2 intravenously over 60 minutes on days 1-3), and dexamethasone (20mg/d orally on days 1-4 and days 11-14), which was administered every 21 days.
Cancer Hospital and Institute, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)
Beijing, Beijing Municipality, China
2-year progression-free survival
Time frame: 2 year
2-year overall survival
Time frame: 2 year
number of patients with adverse events
Time frame: 2 year
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