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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Asan Medical Center
Yonsei University
Seoul National University
Chonnam National University
Information provided by (Responsible Party):
Kim, Seok Jin, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01238159
First received: September 8, 2010
Last updated: January 12, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type
Radiation: CCRT+MIDLE chemotherapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Complete response [ Time Frame: Within 4 weeks after the completion of planned treatment ] [ Designated as safety issue: No ]
    The response criteria was based on the International Working Group Report (1999).


Secondary Outcome Measures:
  • Overall response rate [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
    Overall response rate includes complete and partial response.

  • overall survival [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
    Overall survival is defined as the time interval between the date of diagnosis and the date of death with any cause.

  • Progression-free survival [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 30
Study Start Date: August 2010
Estimated Study Completion Date: December 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Chemoradiotherapy

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01238159

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135710
Sponsors and Collaborators
Samsung Medical Center
Asan Medical Center
Yonsei University
Seoul National University
Chonnam National University
Investigators
Principal Investigator: Won Seog Kim, MD, PhD Samsung Medical Center
  More Information

No publications provided

Responsible Party: Kim, Seok Jin, Associate professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01238159     History of Changes
Other Study ID Numbers: 2010-06-019
Study First Received: September 8, 2010
Last Updated: January 12, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
Natural killer cell
T cell
Lymphoma
Radiation
Chemotherapy

Additional relevant MeSH terms:
Lymphoma, T-Cell
Lymphoma
Lymphoma, Extranodal NK-T-Cell
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on October 01, 2014