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| Name | Class |
|---|---|
| Asan Medical Center | OTHER |
| Yonsei University | OTHER |
| Seoul National University | OTHER |
| Chonnam National University |
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The purpose of this study is to evaluate the efficacy of concomitant chemoradiation followed by MIDLE chemotherapy for stage I/II extranodal NK/T cell lymphoma.
Concomitant chemo-radiotherapy:
Radiation 36-44 Gy/18-22 fractions (2 Gy/fraction) Weekly Cisplatin 30mg/m2 + N/S 100ml MIV over 30min Tri-weekly L-asparaginase 4000 IU IV (D1, 3, 5)
Rest period: 3 weeks
MIDLE chemotherapy: Repeated every 28 days for 2 cycles D1 Methotrexate 3g/m2 + D5W 500ml MIV over 6 hours D2-D3 Etoposide 100mg/m2 + D5W 500ml MIV over 90mins D2-D3 Ifosfamide 1000mg/m2 + D5W 100ml MIV over 1hr D2-D3 Mesna 300mg/m2 + D5W 100ml MIV over 15mins (-15min, 4hrs and 8hrs after ifosfamide, total 3 doses) D1-D4 Dexamethasone 40mg/d PO or IV D4, 6, 8, 14, 10 L-asparaginase 6000IU/m2 + D5W 500ml MIV over 2hours
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CCRT+MIDLE | Experimental | Patients who are planned to be treated with CCRT plus MIDLE chemotherapy. CCRT means concurrent chemoradiation, and MIDLE represent systemic chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CCRT+MIDLE chemotherapy | Radiation | Patients are planned to be treated with CCRT plus MIDLE chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete response | The response criteria was based on the International Working Group Report (1999). | Within 4 weeks after the completion of planned treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | Overall response rate includes complete and partial response. | Up to 2 years |
| overall survival | Overall survival is defined as the time interval between the date of diagnosis and the date of death with any cause. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Won Seog Kim, MD, PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 135710 | South Korea |
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| ID | Term |
|---|---|
| D054391 | Lymphoma, Extranodal NK-T-Cell |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D059248 | Chemoradiotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011878 | Radiotherapy |
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| OTHER |
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| up to 2 years |
| Progression-free survival | Progression-free survival is defined as the time interval between the the date of diagnosis and the date of death with any cause or disease progression/relapse. | up to 2 years |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |