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

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ClinicalTrials.gov Identifier: NCT01007526
Recruitment Status : Completed
First Posted : November 4, 2009
Results First Posted : February 7, 2019
Last Update Posted : February 7, 2019
Sponsor:
Collaborators:
Asan Medical Center
National Cancer Center, Korea
Severance Hospital
Information provided by (Responsible Party):
Won Seog Kim, Samsung Medical Center

Tracking Information
First Submitted Date  ICMJE November 2, 2009
First Posted Date  ICMJE November 4, 2009
Results First Submitted Date  ICMJE December 30, 2012
Results First Posted Date  ICMJE February 7, 2019
Last Update Posted Date February 7, 2019
Study Start Date  ICMJE April 2008
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2018)
Compete Response Rate [ Time Frame: 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
Original Primary Outcome Measures  ICMJE
 (submitted: November 3, 2009)
Compete Response Rate [ Time Frame: Within 3 weeks after the completion fo treatment ]
Change History Complete list of historical versions of study NCT01007526 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2009)
Overall Response Rate, Survival, Toxicity [ Time Frame: Up to 5 years after the completion of treatment ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Concomitant Chemo-radiotherapy Plus VIDL Chemotherapy in NK/T-cell Lymphoma
Official Title  ICMJE 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
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
VIDL (Etoposide, ifosfamide, dexamethasone and L-asparaginase)
Masking: None (Open Label)
Masking Description:
Concomitant Chemo-radiotherapy Plus VIDL Chemotherapy
Primary Purpose: Treatment
Condition  ICMJE NK/T-cell Lymphoma of Nasal Cavity
Intervention  ICMJE Other: CCRT 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
Study Arms  ICMJE Experimental: 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
Intervention: Other: CCRT followed by VIDL chemotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 5, 2018)
31
Original Estimated Enrollment  ICMJE
 (submitted: November 3, 2009)
30
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01007526
Other Study ID Numbers  ICMJE 2008-04-033
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Won Seog Kim, Samsung Medical Center
Study Sponsor  ICMJE Samsung Medical Center
Collaborators  ICMJE
  • Asan Medical Center
  • National Cancer Center, Korea
  • Severance Hospital
Investigators  ICMJE
Principal Investigator: Won Seog Kim, MD, PhD Samsung Medical Center
PRS Account Samsung Medical Center
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP