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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

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

Intervention / Treatment
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* Radiation: CCRT+MIDLE chemotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CCRT+MIDLE<br>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<br>* Patients are planned to be treated with CCRT plus MIDLE chemotherapy<br>* Other names: Chemoradiotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response | The response criteria was based on the International Working Group Report (1999). | Within 4 weeks after the completion of planned treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate | Overall response rate includes complete and partial response. | Up to 2 years | 
| overall survival | Overall survival is defined as the time interval between the date of diagnosis and the date of death with any cause. | up to 2 years | 
| Progression-free survival | 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. | up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Natural killer cell, T cell, Lymphoma, Radiation, Chemotherapy