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

Phase 2

Completed

• Conditions: Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type
• Interventions: Radiation: CCRT+MIDLE chemotherapy

• Registration Number: NCT01238159
• Lead Sponsor: Samsung Medical Center

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 Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-09-08
• Study First Submitted QC: 2010-11-09
• Study First Posted: 2010-11-10
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-01
• Last Update Posted: 2015-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CCRT+MIDLE	CCRT+MIDLE chemotherapy	Patients who are planned to be treated with CCRT plus MIDLE chemotherapy. CCRT means concurrent chemoradiation, and MIDLE represent systemic chemotherapy.

Primary Outcome Measures

Name	Time	Method
Complete response	Within 4 weeks after the completion of planned treatment	The response criteria was based on the International Working Group Report (1999).

Secondary Outcome Measures

Name	Time	Method
Overall response rate	Up to 2 years	Overall response rate includes complete and partial response.
overall survival	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	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.

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of