Status:
COMPLETED
Concomitant Chemo-radiotherapy Followed by MIDLE Chemotherapy in Stage I/II Extranodal NK/T-cell Lymphoma
Lead Sponsor:
Samsung Medical Center
Collaborating Sponsors:
Asan Medical Center
Yonsei University
Conditions:
Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01238159
Start Date
August 1 2010
End Date
December 1 2014
Last Update
March 3 2015
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea, 135710