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| Name | Class |
|---|---|
| 307 Hospital of PLA | OTHER |
| Tianjin Medical University Cancer Institute and Hospital | OTHER |
| First Hospital of China Medical University | OTHER |
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The first Part: recruiting untreated ENKL patients with extensive stage I or limited stage II disease (only referring to patients with the invasion of Waldeyer's ring and cervical lymph nodes) . Patients are randomly divided into two arms, IPGDP regimen chemotherapy followed by radiotherapy or radiotherapy followed by IPGDP regimen chemotherapy. IPGDP regimen for both arms are 3 cycles. And the chemotherapy is repeated every 3 weeks..
The second part: recruiting extensive stage II ,stage III-IV, relapsed or refractory ENKL patients. Patients receive 6 cycles of IPGDP regimen chemotherapy. And the chemotherapy is repeated every 3 weeks.
The first Part: Patients in IPGDP regimen chemotherapy followed by radiotherapy arm receive 3 cycles of IPGDP (ifosfamide 1.2g/m2 iv on days 3-5; pegaspargase 2000U/m2 im on day 1; gemcitabine 800mg/m2 iv on days 3,8; cisplatin 25 mg/m2 iv on days 3-5; dexamethasone 20mg/m2 iv on days 3-6) chemotherapy. Then patients undergo radiotherapy. If the disease is considered to progress or as stable during chemotherapy, the patient will directly receive radiotherapy. Patients in another arm receive radiotherapy followed by IPGDP regimen chemotherapy. IPGDP regimen for both arms are 3 cycles, which is repeated every 3 weeks.
The second Part: Patients receive 6 cycles of ifosfamide 1.2g/m2 iv on days 3-5; pegaspargase 2000U/m2 im on day 1; gemcitabine 800mg/m2 iv on days 3,8; cisplatin 25 mg/m2 iv on days 3-5; dexamethasone 20mg/m2 iv on days 3-6. IPGDP regimen is repeated every 3 weeks. If the disease is considered to progress or as stable after 2 cycles or 4 cycles of chemotherapy, the patient will withdraw from this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chemotherapy followed by radiotherapy | Other | Patients receive 3 cycles of IPGDP (ifosfamide 1.2g/m2 iv on days 3-5; pegaspargase 2000U/m2 im on day 1; gemcitabine 800mg/m2 iv on days 3,8; cisplatin 25 mg/m2 iv on days 3-5; dexamethasone 20mg/m2 iv on days 3-6) chemotherapy followed by radiotherapy. |
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| radiotherapy followed by chemotherapy | Other | Patients receive radiotherapy followed by 3 cycles of IPGDP (ifosfamide 1.2g/m2 iv on days 3-5; pegaspargase 2000U/m2 im on day 1; gemcitabine 800mg/m2 iv on days 3,8; cisplatin 25 mg/m2 iv on days 3-5; dexamethasone 20mg/m2 iv on days 3-6) chemotherapy. |
|
| IPGDP regimen chemotherapy | Other | Patients receive 6 cycles of ifosfamide 1.2g/m2 iv on days 3-5; pegaspargase 2000U/m2 im on day 1; gemcitabine 800mg/m2 iv on days 3,8; cisplatin 25 mg/m2 iv on days 3-5; dexamethasone 20mg/m2 iv on days 3-6. 6 cycles, every 3 weeks one cycle. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chemotherapy followed by radiotherapy | Other |
| ||
| radiotherapy followed by chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival | 5 years |
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Inclusion Criteria:
Bone marrow: absolute neutrophil count (ANC) >or equal to 1.5 * 109/L, platelets >or equal to 100 *109/L, hemoglobin > or equal to 9g/dL.
Hepatic: bilirubin < or equal to 2 x ULN; aspartate transaminase (AST) and alanine transaminase (ALT) < or equal to 2.5 x ULN (AST, ALT < or equal to 5 x ULN is acceptable if liver has been involved).
Renal: serum creatinine < or equal to 1.5 x ULN. Coagulation function :activated partial thromboplastin time < or equal to 1.5 x ULN, fibrinogen > or equal to 0.75 times of the lower limit of the normal value, INR < or equal to 1.5 x ULN.
Exclusion Criteria:
Hepatic: bilirubin > 2 x ULN; aspartate transaminase (AST) and alanine transaminase (ALT) >2.5 x ULN (AST, ALT > 5 x ULN is acceptable if liver has been involved).
Renal: serum creatinine > 1.5 x ULN. Abnormal Coagulation function : such as activated partial thromboplastin time prolonged > 1.5 x ULN, fibrinogen < 0.75 times of the lower limit of the normal value, increased INR > 1.5 x ULN any other important clinical or laboratory abnormalities that are not appropriate for research
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuankai Shi | Contact | 87788293 | syuankaipumc@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College | Recruiting | Beijing | China |
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| The Second Affiliated Hospital of Dalian Medical University |
| OTHER |
| Hebei Medical University Fourth Hospital | OTHER |
| Qilu Hospital of Shandong University | OTHER |
| Shandong Cancer Hospital and Institute | OTHER |
| Nanfang Hospital, Southern Medical University | OTHER |
| Guangdong Provincial People's Hospital | OTHER |
| People's Hospital of Guangxi Zhuang Autonomous Region | OTHER |
| Xuzhou Medical University | OTHER |
| Shanxi Province Cancer Hospital | OTHER |
| Shanxi Dayi Hospital | OTHER |
| Zhangzhou Municipal Hospital of Fujian Province | OTHER |
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| Other |
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| IPGDP regimen chemotherapy | Drug |
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| People's Hospital of Guangxi | Recruiting | Nanning | China |
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| Fourth Hospital of Hebei Medical University | Recruiting | Shijiazhuang | China |
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| Shanxi Dayi Hospital | Recruiting | Taiyuan | China |
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| Shanxi Province Cancer Hospital | Recruiting | Taiyuan | China |
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| 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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