NK/T-cell Lymphoma of Nasal Cavity
Conditions
Keywords
Extranodal Lymphoma, Natural killer cell, T cell, Radiotherapy, Chemotherapy
Brief summary
This study is to evaluate the efficacy of risk-adapted treatment strategy for stage I/II extranodal NK/T cell lymphoma. The risk stratification is based on the Korean NK prognostic index. Thus, the group I/II will receive concomitant chemoradiation followed by VIDL chemotherapy. The group III/IV will receive high dose-chemotherapy followed by autologous stem cell transplantation after the completion of VIDL chemotherapy.
Detailed description
1. Concomitant chemo-radiotherapy: Radiotherapy 36-44 Gy/18-22 fractions \+ weekly cisplatin 30 mg/m2 for 4 weeks 2. Rest period: 3 weeks 3. VIDL combination chemotherapy: (total 2 cycles) VP-16 (etoposide) 100mg/m2 I.V. D1-3 Ifosfamide 1.2g/m2 I.V. D1-3 Dexamethasone 40mg/day D1-3 L-asparaginase 4000IU/m2 IM D8, 10, 12, 14, 16, 18, 20 Repeated every 28 days 4. Peripheral blood stem cell mobilization G-CSF 400ug/m2/day or 10ug/kg/day S.C. or I.V. for 4-6 days followed by stem cell collection (Minimum requirement of CD34+ cells \> 2×106/kg) 5. High-dose chemotherapy with autologous stem cell transplantation Busulfex 3.2mg/kg/day from day -7 to day -5 Etoposide 400mg/m2/day on day -5, -4 Cyclophosphamide 50mg/kg/day on day -3, -2 Followed by stem cell infusion
Interventions
OTHERCCRT followed by VIDL chemotherapy
CCRT followed by VIDL chemotherapy concomitant chemo-radiotherapy followed by VIDL (VP-16, Ifosfamide, Dexamethasone, L-asparaginase) chemotherapy with risk-based application of autologous stem cell transplantation
Sponsors
Asan Medical Center
National Cancer Center, Korea
Severance Hospital
Samsung Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Concomitant Chemo-radiotherapy Plus VIDL Chemotherapy
Intervention model description
VIDL (Etoposide, ifosfamide, dexamethasone and L-asparaginase)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compete Response Rate | Within 3 weeks after the completion fo treatment | Response was determined by the revised response criteria for malignant lymphoma (Cheson BD et al. J Clin Oncol. 2007 Feb 10;25(5):579-86.): 1) Complete response 2) Partial response 3) Stable disease 4) Progressive disease |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response Rate, Survival, Toxicity | Up to 5 years after the completion of treatment |
Countries
South Korea
Participant flow
Recruitment details
Recruitment between August 2008 and October 2010 Location: University hospital or Institutes
Participants by arm
| Arm | Count |
|---|---|
| CCRT Plus VIDL CCRT followed by VIDL chemotherapy Concomitant chemo-radiotherapy followed by VIDL chemotherapy with risk-based application of autologous stem cell transplantation Patients who are planned to be treated with CCRT plus VIDL chemotherapy and/or autologous stem cell transplantation | 31 |
| Total | 31 |
Baseline characteristics
| Characteristic | CCRT Plus VIDL |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants |
| Age, Continuous | 47.1 years STANDARD_DEVIATION 12.7 |
| Region of Enrollment Korea, Republic of | 31 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 30 / 30 |
| serious Total, serious adverse events | 0 / 31 |
Outcome results
Primary
Compete Response Rate
Response was determined by the revised response criteria for malignant lymphoma (Cheson BD et al. J Clin Oncol. 2007 Feb 10;25(5):579-86.): 1) Complete response 2) Partial response 3) Stable disease 4) Progressive disease
Time frame: Within 3 weeks after the completion fo treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CCRT Plus VIDL | Compete Response Rate | 31 participants |
Secondary
Overall Response Rate, Survival, Toxicity
Time frame: Up to 5 years after the completion of treatment