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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Samsung Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Asan Medical Center
National Cancer Center, Korea
Severance Hospital
Information provided by (Responsible Party):
Won Seog Kim, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01007526
First received: November 2, 2009
Last updated: May 22, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Stage I/II Extranodal NK/T-cell Lymphoma
Other: concomitant chemo-radiotherapy followed by VIDL chemotherapy with risk-based application of autologous stem cell transplantation
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Compete response rate [ Time Frame: Within 3 weeks after the completion fo treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response rate, survival, toxicity [ Time Frame: Up to 5 years after the completion of treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: April 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients who are planned to be treated with CCRT plus VIDL chemotherapy and/or autologous stem cell transplantation
Other: concomitant chemo-radiotherapy followed by VIDL chemotherapy with risk-based application of autologous stem cell transplantation
concomitant chemo-radiotherapy followed by VIDL (VP-16, Ifosfamide, Dexamethasone, L-asparaginase) chemotherapy with risk-based application of autologous stem cell transplantation

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01007526

Contacts
Contact: Won Seog Kim, MD, PhD 82234106548 wskimsmc@skku.edu

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Principal Investigator: Won Seog Kim, MD, PhD         
Sponsors and Collaborators
Samsung Medical Center
Asan Medical Center
National Cancer Center, Korea
Severance Hospital
Investigators
Principal Investigator: Won Seog Kim, MD, PhD Samsung Medical Center
  More Information

No publications provided

Responsible Party: Won Seog Kim, Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01007526     History of Changes
Other Study ID Numbers: 2008-04-033
Study First Received: November 2, 2009
Last Updated: May 22, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Samsung Medical Center:
Extranodal Lymphoma
Natural killer cell
T cell
Radiotherapy
Chemotherapy

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on August 20, 2014