Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Asan Medical Center | OTHER |
| National Cancer Center, Korea | OTHER_GOV |
| Severance Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Concomitant chemo-radiotherapy:
Radiotherapy 36-44 Gy/18-22 fractions
+ weekly cisplatin 30 mg/m2 for 4 weeks
Rest period: 3 weeks
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
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)
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CCRT plus VIDL | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CCRT followed by VIDL chemotherapy | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Within 3 weeks after the completion fo treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate, Survival, Toxicity | Up to 5 years after the completion of treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Won Seog Kim, MD, PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 135-710 | South Korea |
Not provided
Recruitment between August 2008 and October 2010 Location: University hospital or Institutes
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Number | participants | Within 3 weeks after the completion fo treatment |
|
|
6 months after registration
We applied the same definition as the clinicaltrials.gov.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Won Seog Kim | Samsung Medical Center | 82234106548 | wskimsmc@skku.edu |
Not provided
VIDL (Etoposide, ifosfamide, dexamethasone and L-asparaginase)
Not provided
Not provided
Concomitant Chemo-radiotherapy Plus VIDL Chemotherapy
Not provided
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Overall Response Rate, Survival, Toxicity | Not Posted | Up to 5 years after the completion of treatment | Participants |
| 0 |
| 31 |
| 30 |
| 30 |
Not provided
Not provided
Not provided