Spots Global Cancer Trial Database for Concomitant Chemo-radiotherapy Followed by MIDLE Chemotherapy in Stage I/II Extranodal NK/T-cell Lymphoma

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Trial Identification

Brief Title: Concomitant Chemo-radiotherapy Followed by MIDLE Chemotherapy in Stage I/II Extranodal NK/T-cell Lymphoma

Official Title: Open-labeled, Multicenter Phase II Study of Concomitant Chemo-radiotherapy Followed by MIDLE (Methotrexate, Ifosfamide, Dexamethasone, L-asparaginase, Etoposide) Chemotherapy in Stage I/II Extranodal NK/T-cell Lymphoma

Study ID: NCT01238159

Conditions

Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type

Interventions

CCRT+MIDLE chemotherapy

Study Description

Brief Summary: 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.

Detailed Description: 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