Concomitant Chemo-radiotherapy Followed by MIDLE Chemotherapy in Stage I/II Extranodal NK/T-cell Lymphoma
|Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type||Radiation: CCRT+MIDLE chemotherapy||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Complete response [ Time Frame: Within 4 weeks after the completion of planned treatment ]The response criteria was based on the International Working Group Report (1999).
- Overall response rate [ Time Frame: Up to 2 years ]Overall response rate includes complete and partial response.
- overall survival [ Time Frame: up to 2 years ]Overall survival is defined as the time interval between the date of diagnosis and the date of death with any cause.
- Progression-free survival [ Time Frame: up to 2 years ]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.
|Study Start Date:||August 2010|
|Study Completion Date:||December 2014|
|Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Patients who are planned to be treated with CCRT plus MIDLE chemotherapy. CCRT means concurrent chemoradiation, and MIDLE represent systemic chemotherapy.
Radiation: CCRT+MIDLE chemotherapy
Patients are planned to be treated with CCRT plus MIDLE chemotherapy
Other Name: Chemoradiotherapy
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01238159
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Korea, Republic of, 135710|
|Principal Investigator:||Won Seog Kim, MD, PhD||Samsung Medical Center|