The purpose of this study is to evaluate the efficacy and safety of DDGP regiment (gemcitabine,pegaspargase,cisplatin,dexamethasone) for patients with newly diagnosed stage I/II Natural Killer (NK)/T Cell Lymphoma.
Patients with NK/T cell lymphoma usually have a bad prognosis. These patients cannot be treated successfully with the conventional chemotherapy of CHOP. The investigators have been proceeding this trial to evaluate the efficacy and safety of the combination chemotherapy regiment DDGP (gemcitabine,pegaspargase, cisplatin, dexamethasone) in the patients with stage I/II NK/T cell lymphoma.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
DDP 20 mg/m2,ivgtt(intravenously guttae), d1-4;DEX 15mg/m2,ivgtt,d1-5;GEM 800mg/m2,ivgtt,30min,d1,8;Pegasparaginase,im,2500IU/m2 d1.Every 21 days for one cycle and three cycles are required. Completion of chemotherapy is followed by radiotherapy 50Gy.Efficacy was evaluated every two cycles.
DDP,33mg/m2,ivgtt(intravenously guttae),d1-3;VP-16,100mg/m2,ivgtt,d1-3;IFO,1.2g/m2,ivgtt,d1-3;DEX,40mg,ivgtt,d1-4;Mesna,0、4、8h after IFO,240mg/m2,iv,d1-3.Every 21 days for one cycle and three cycles are required. Completion of chemotherapy is followed by radiotherapy 50Gy.Efficacy was evaluated every two cycles.
Oncology Department of The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
RECRUITINGProgression-free survival
Time frame: up to end of follow-up-phase (approximately 24 months)
Response rate
21 days(3 weeks) for one cycle,Efficacy was evaluated every two cycles.
Time frame: every 6 weeks,up to completion of treatment(approximately 18 weeks )
overall survival
Time frame: up to the date of death (approximately 5 years)
median survival time
Time frame: 5 years
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Radiotherapy 50Gy is followed by chemotherapy(DDP 20 mg/m2,ivgtt(intravenously guttae),d1-4;DEX 15mg/m2,ivgtt,d1-5;GEM 800mg/m2,ivgtt,30min,d1,8;Pegasparaginase,im,2500IU/m2 d1.Every 21 days for one cycle and three cycles are required ).Efficacy was evaluated every two cycles.
Radiotherapy 50Gy is followed by chemotherapy(DDP,33mg/m2,ivgtt(intravenously guttae),d1-3;VP-16,100mg/m2,ivgtt,d1-3;IFO,1.2g/m2,ivgtt,d1-3;DEX,40mg,ivgtt,d1-4;Mesna,0、4、8h after IFO,240mg/m2,iv,d1-3.Every 21 days for one cycle and three cycles are required ).Efficacy was evaluated every two cycles.
Suitable type intensity-modulated radiation therapy(IMRT)50Gy