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:
Samsung Medical Center
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
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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
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 Lymphoma, T-Cell Lymphoma, Extranodal NK-T-Cell Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin |
ClinicalTrials.gov processed this record on May 16, 2013