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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Samsung Medical Center
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Complete response
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients were required to have a biopsy-proven diagnosis of nasal ENKTL
- •at least 18 years old
- •Ann Arbor stage IE or IIE
- •measurable disease
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 life expectancy greater than 12 weeks
- •adequate hematologic (hemoglobin > 9.0 g/dL, absolute neutrophil count > 1,500/uL and platelets > 100,000/uL)
- •renal (serum creatinine < 1.5 mg/dL, creatinine clearance > 50 mL/min)
- •hepatic (total bilirubin < 2 times of upper limit of normal and aspartate transferase < 3 times of upper limit of normal) function
- •Diagnosis of ENKTL is based on the presence of histological features and immunophenotypes compatible with ENKTL (e.g., cytoplasmic CD3+, CD20-, CD56+,
- •positive for cytotoxic molecules
- •positive for EBV by in situ hybridization).
- •Informed consent
Exclusion Criteria
- •prior or concomitant malignant tumors
- •any coexisting medical problems of sufficient severity to prevent full compliance with the study protocol.
- •ENKTL with non-nasal sites such as skin or gastrointestinal tract was excluded even if it is localized.
- •Other subtypes of non-Hodgkin lymphoma (NHL), including myeloid/NK cell precursor acute leukemia, blastic NK cell lymphoma/precursor NK cell lymphoblastic leukemia, aggressive NK cell leukemia, and peripheral T cell lymphoma, unspecified, were excluded.
Arms & Interventions
CCRT+MIDLE
Patients who are planned to be treated with CCRT plus MIDLE chemotherapy. CCRT means concurrent chemoradiation, and MIDLE represent systemic chemotherapy.
Intervention: CCRT+MIDLE chemotherapy (Radiation)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Overall response rate(Up to 2 years)
- overall survival(up to 2 years)
- Progression-free survival(up to 2 years)
Investigators
Kim, Seok Jin
Associate professor
Samsung Medical Center