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

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
CCRT+MIDLE chemotherapy
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type focused on measuring Natural killer cell, T cell, Lymphoma, Radiation, Chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CCRT+MIDLE

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall response rate
Overall response rate includes complete and partial response.
overall survival
Overall survival is defined as the time interval between the date of diagnosis and the date of death with any cause.
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.

Full Information

First Posted
September 8, 2010
Last Updated
March 1, 2015
Sponsor
Samsung Medical Center
Collaborators
Asan Medical Center, Yonsei University, Seoul National University, Chonnam National University
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1. Study Identification

Unique Protocol Identification Number
NCT01238159
Brief Title
Concomitant Chemo-radiotherapy Followed by MIDLE Chemotherapy in Stage I/II Extranodal NK/T-cell Lymphoma
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 Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
Collaborators
Asan Medical Center, Yonsei University, Seoul National University, Chonnam National University

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type
Keywords
Natural killer cell, T cell, Lymphoma, Radiation, Chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CCRT+MIDLE
Arm Type
Experimental
Arm Description
Patients who are planned to be treated with CCRT plus MIDLE chemotherapy. CCRT means concurrent chemoradiation, and MIDLE represent systemic chemotherapy.
Intervention Type
Radiation
Intervention Name(s)
CCRT+MIDLE chemotherapy
Other Intervention Name(s)
Chemoradiotherapy
Intervention Description
Patients are planned to be treated with CCRT plus MIDLE chemotherapy
Primary Outcome Measure Information:
Title
Complete response
Description
The response criteria was based on the International Working Group Report (1999).
Time Frame
Within 4 weeks after the completion of planned treatment
Secondary Outcome Measure Information:
Title
Overall response rate
Description
Overall response rate includes complete and partial response.
Time Frame
Up to 2 years
Title
overall survival
Description
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
Title
Progression-free survival
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Won Seog Kim, MD, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135710
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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