search
Back to results

Concomitant Chemo-radiotherapy Plus VIDL Chemotherapy in NK/T-cell Lymphoma (CCRT-VIDL)

Primary Purpose

NK/T-cell Lymphoma of Nasal Cavity

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

About this trial

This is an interventional treatment trial for NK/T-cell Lymphoma of Nasal Cavity focused on measuring Extranodal Lymphoma, Natural killer cell, T cell, Radiotherapy, 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 plus VIDL

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall Response Rate, Survival, Toxicity

Full Information

First Posted
November 2, 2009
Last Updated
September 5, 2018
Sponsor
Samsung Medical Center
Collaborators
Asan Medical Center, National Cancer Center, Korea, Severance Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01007526
Brief Title
Concomitant Chemo-radiotherapy Plus VIDL Chemotherapy in NK/T-cell Lymphoma
Acronym
CCRT-VIDL
Official Title
Open-labeled, Multicenter Phase II Study of Concomitant Chemo-radiotherapy Followed by VIDL Chemotherapy With Risk-based Application of Autologous Stem Cell Transplantation in Stage I/II Extranodal NK/T-cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
Collaborators
Asan Medical Center, National Cancer Center, Korea, Severance Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NK/T-cell Lymphoma of Nasal Cavity
Keywords
Extranodal Lymphoma, Natural killer cell, T cell, Radiotherapy, Chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
VIDL (Etoposide, ifosfamide, dexamethasone and L-asparaginase)
Masking
None (Open Label)
Masking Description
Concomitant Chemo-radiotherapy Plus VIDL Chemotherapy
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CCRT plus VIDL
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
CCRT followed by VIDL chemotherapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Compete Response Rate
Description
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
Secondary Outcome Measure Information:
Title
Overall Response Rate, Survival, Toxicity
Time Frame
Up to 5 years after the completion of treatment

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
135-710
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Concomitant Chemo-radiotherapy Plus VIDL Chemotherapy in NK/T-cell Lymphoma

We'll reach out to this number within 24 hrs