NCT01238159

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

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

Interventions

Type	Name	Description
RADIATION	CCRT+MIDLE chemotherapy	Patients are planned to be treated with CCRT plus MIDLE chemotherapy

Timeline

• Start date: 2010-08-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2010-11-10
• Last updated: 2015-03-03

Locations

1 site across 1 country: South Korea