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
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
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Complete response
The response criteria was based on the International Working Group Report (1999).
Within 4 weeks after the completion of planned treatment
No
Won Seog Kim, MD, PhD
Principal Investigator
Samsung Medical Center
Korea: Institutional Review Board
2010-06-019
NCT01238159
August 2010
December 2013
Name | Location |
---|