A Phase 4 interventional study of DDGP(cisplatin,dexamethasone,gemcitabine,pegaspargase) and VIPD（cisplatin，Etoposide，Ifosfamide， dexamethasone，Mesna） in Nasal and Nasal-type NK/T-cell Lymphoma, sponsored by Mingzhi Zhang. Status unknown at 1 site in China. Open to participants aged 14 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-07-17.
Sponsored by Mingzhi Zhang · Phase 4, Interventional, and Treatment
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's planned enrollment of 200 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
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Exclusion Criteria:
sequential DDGP(gemcitabine,pegaspargase,cisplatin,dexamethasone) regiment followed by radiotherapy
Other: DDGP(cisplatin,dexamethasone,gemcitabine,pegaspargase)
sequential VIPD（cisplatin，Etoposide,Ifosfamide,dexamethasone，Mesna） regiment followed by radiotherapy
Other: VIPD（cisplatin，Etoposide，Ifosfamide， dexamethasone，Mesna）
sequential radiotherapy followed by DDGP(gemcitabine,pegaspargase,cisplatin,dexamethasone) regiment
Other: gemcitabine,pegaspargase,cisplatin,dexamethasone
sequential radiotherapy followed by VIPD（cisplatin,Etoposide,Ifosfamide,dexamethasone,Mesna）regiment chemotherapy
Other: cisplatin,Etoposide,Ifosfamide,dexamethasone,Mesna
Suitable type intensity-modulated radiation therapy (IMRT) 50GY
Radiation: Radiotherapy
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.
Also known as: DDGP, chemotherapy, radiotherapy
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.
Also known as: VIPD, chemotherapy, radiotherapy
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.
Also known as: radiotherapy, chemotherapy, DDGP
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.
Also known as: radiotherapy, chemotherapy, VIPD
Suitable type intensity-modulated radiation therapy(IMRT)50Gy
Progression-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
This study is status unknown, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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Mingzhi Zhang