Clinical trial · Interventional
Concomitant Chemo-radiotherapy Followed by MIDLE Chemotherapy in Stage I/II Extranodal NK/T-cell Lymphoma
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
NCT01238159CI-TRIAL-00016960completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type | Nasal Type Extranodal NK/T-Cell Lymphoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CCRT+MIDLE chemotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CCRT+MIDLE
- description
- Patients who are planned to be treated with CCRT plus MIDLE chemotherapy. CCRT means concurrent chemoradiation, and MIDLE represent systemic chemotherapy.
- interventionNames
- Radiation: CCRT+MIDLE chemotherapy
Primary outcomes (1)
- measure
- Complete response
- timeFrame
- Within 4 weeks after the completion of planned treatment
- description
- The response criteria was based on the International Working Group Report (1999).
Secondary outcomes (3)
- measure
- Overall response rate
- timeFrame
- Up to 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.