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

Sponsor

Samsung Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01238159

Collaborator

Asan Medical Center (Other), Yonsei University (Other), Seoul National University (Other), Chonnam National University (Other)

Enrollment

Location

Arm

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type	Radiation: CCRT+MIDLE chemotherapy	Phase 2

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

Actual Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Aug 1, 2010

Actual Primary Completion Date :

Dec 1, 2014

Actual Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CCRT+MIDLE 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 Patients are planned to be treated with CCRT plus MIDLE chemotherapy Other Names: Chemoradiotherapy

Arm

Intervention/Treatment

Experimental: CCRT+MIDLE

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

Patients are planned to be treated with CCRT plus MIDLE chemotherapy

Other Names:

Chemoradiotherapy

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.