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| Name | Class |
|---|---|
| Second Hospital of Shanxi Medical University | OTHER |
| Shanxi Province Cancer Hospital | OTHER |
| Wuhan University | OTHER |
| Wuhan TongJi Hospital |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sequential trial,DDGP, radiotherapy | Experimental | sequential DDGP(gemcitabine,pegaspargase,cisplatin,dexamethasone) regiment followed by radiotherapy |
|
| sequential trial,VIPD, radiotherapy | Experimental | sequential VIPD（cisplatin，Etoposide,Ifosfamide,dexamethasone，Mesna） regiment followed by radiotherapy |
|
| sequential trial, radiotherapy,DDGP | Experimental | sequential radiotherapy followed by DDGP(gemcitabine,pegaspargase,cisplatin,dexamethasone) regiment |
|
| sequential trial,radiotherapy, VIPD | Experimental | sequential radiotherapy followed by VIPD（cisplatin,Etoposide,Ifosfamide,dexamethasone,Mesna）regiment chemotherapy |
|
| Radiotherapy | Experimental | Suitable type intensity-modulated radiation therapy (IMRT) 50GY |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DDGP(cisplatin,dexamethasone,gemcitabine,pegaspargase) | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | up to end of follow-up-phase (approximately 24 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | 21 days(3 weeks) for one cycle,Efficacy was evaluated every two cycles. | every 6 weeks,up to completion of treatment(approximately 18 weeks ) |
| overall survival | up to the date of death (approximately 5 years) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mingzhi Zhang, Pro，Dr | Contact | 13838565629 | mingzhi_zhang@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Mingzhi Zhang, Pro,Dr | The First Affiliated Hospital of Zhengzhou University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncology Department of The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450052 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33034052 | Derived | Zhang L, Wang Y, Li X, Li L, Wang X, Sun Z, Wu J, Fu X, Zhang X, Yu H, Wang G, Chang Y, Yan J, Zhou Z, Wu X, Nan F, Li W, Zhang M. Radiotherapy vs sequential pegaspargase, gemcitabine, cisplatin and dexamethasone and radiotherapy in newly diagnosed early natural killer/T-cell lymphoma: A randomized, controlled, open-label, multicenter study. Int J Cancer. 2021 Mar 15;148(6):1470-1477. doi: 10.1002/ijc.33329. Epub 2020 Oct 19. |
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| OTHER |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology | OTHER |
| Qingdao University | OTHER |
| Cancer Hospital of Guizhou Province | OTHER |
| Xinyang Central Hospital | OTHER |
| The First Affiliated Hospital of Henan University of Traditional Chinese Medicine | OTHER |
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|
| VIPD（cisplatin，Etoposide，Ifosfamide， dexamethasone，Mesna） | Other | 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. |
|
|
| gemcitabine,pegaspargase,cisplatin,dexamethasone | Other | 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. |
|
|
| cisplatin,Etoposide,Ifosfamide,dexamethasone,Mesna | Other | 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. |
|
|
| Radiotherapy | Radiation | Suitable type intensity-modulated radiation therapy(IMRT)50Gy |
|
| median survival time | 5 years |
| ID | Term |
|---|---|
| D054391 | Lymphoma, Extranodal NK-T-Cell |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
| D000093542 | Gemcitabine |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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