Clinical trial NCT01238159: Concomitant Chemo-radiotherapy Followed by MIDLE Chemotherapy in Stage I/II Extranodal NK/T-cell Lymphoma
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type
Keywords: Natural killer cell
T cell
Lymphoma
Radiation
Chemotherapy
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Asan Medical Center
name: Yonsei University
name: Seoul National University
name: Chonnam National University
First posted: 2010-11-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Complete response
timeFrame: Within 4 weeks after the completion of planned treatment
Secondary outcomes:
measure: Overall response rate
timeFrame: Up to 2 years
measure: overall survival
timeFrame: up to 2 years
measure: Progression-free survival
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Won Seog Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: