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CompletedNCT01238159Updated Mar 3, 2015

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

A Phase 2 interventional study of CCRT+MIDLE chemotherapy in Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-03.

Sponsored by Samsung Medical Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

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

Keywords

  • Natural killer cell
  • T cell
  • Lymphoma
  • Radiation
  • Chemotherapy
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 30 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • 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

Interventions

  • RadiationCCRT+MIDLE chemotherapy

    Patients are planned to be treated with CCRT plus MIDLE chemotherapy

    Also known as: Chemoradiotherapy

06

What researchers measure

Primary outcomes

  1. Complete response

    The response criteria was based on the International Working Group Report (1999).

    Time frame: Within 4 weeks after the completion of planned treatment

Secondary outcomes

  1. Overall response rate

    Overall response rate includes complete and partial response.

    Time frame: Up to 2 years

  2. overall survival

    Overall survival is defined as the time interval between the date of diagnosis and the date of death with any cause.

    Time frame: up to 2 years

  3. 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.

    Time frame: up to 2 years

07

Study locations

1 site
  • Samsung Medical Center
    Seoul, 135710, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01238159
Lead sponsor
Samsung Medical Center
Collaborators
Asan Medical Center, Yonsei University, Seoul National University, Chonnam National University
Responsible party
Kim, Seok Jin (Associate professor, Samsung Medical Center) — Principal investigator
First posted
Nov 10, 2010
Start date
Aug 2010
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Mar 3, 2015

Study contacts

Won Seog Kim, MD, PhD
principal investigator · Samsung Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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