Clinical Study of Chemoradiation Followed by VIPD in Nasal Natural Killer (NK)/T-cell Lymphoma

This study has been completed.
Sponsor:
Collaborators:
Korea University Anam Hospital
Asan Medical Center
Gyeongsang National University Hospital
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00418535
First received: January 3, 2007
Last updated: October 20, 2009
Last verified: January 2007
  Purpose

Nasal NK/T-cell lymphoma is a peculiar clinico-pathologic subtype of non-Hodgkin's lymphoma (NHL). Although most patients present with stage I/II, only 30-60% of the patients remain disease-free. The efficacy of the conventional anthracycline-based chemotherapy (cyclophosphamide, doxorubicin, vincristine, prednisone [CHOPP]) has been unsatisfactory.

The optimal treatment of localized NK/T-cell lymphoma has not been defined yet. The optimal dose, sequence, and multi-modality treatment with involved field radiotherapy still need to be refined. This trial is to evaluate the efficacy of concurrent chemoradiotherapy with cisplatin followed by VIPD (etoposide, ifosfamide, cisplatin, dexamethasone) in localized NK/T-cell lymphoma patients.


Condition Intervention Phase
Lymphoma, T-Cell
Drug: Concurrent Radiotherapy (RT)/cisplatin, VIPD
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Concurrent Chemoradiation Followed by VIPD (Etoposide/Ifosfamide/Cisplatin/Dexamethasone) in Stage I, II Nasal NK/T-cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Study Start Date: April 2006
Study Completion Date: July 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pathologically confirmed NK/T-cell lymphoma
  • Localized (Ann Arbor stage I/II) disease
  • At least one measurable lesion
  • Age > 18
  • ECOG performance status 0 - 2
  • Expected life span of at least 12 weeks
  • Normal marrow function (hemoglobin ≥ 9.0 g/dL; absolute neutrophil count ≥ 1,500/mm3; platelet count ≥ 100,000/mm3)
  • Normal liver function (total bilirubin < 2x upper limit of normal [ULN], transaminase < 3x ULN)
  • Normal renal function (serum creatinine ≤ 1.5 mg/dL, creatinine clearance ≥ 50 mL/min)
  • Written informed consent

Exclusion Criteria:

  • Other malignancies except for treated non-melanoma skin cancers and cervical cancer in situ
  • Serious medical illnesses (congestive heart failure, angina, respiratory failure, and renal failure)
  • Acute or active infection requiring intravenous (IV) antibiotics
  • Pregnant, lactating women
  • Previous history of chemotherapy or radiotherapy
  • Concomitant medication that may influence the study drugs
  • Allergic reaction to study drugs
  • Grade 2 or greater peripheral neuropathy
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00418535

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Korea University Anam Hospital
Asan Medical Center
Gyeongsang National University Hospital
Investigators
Principal Investigator: Won Seog Kim, MD, Ph.D Samsung Medical Center
  More Information

No publications provided

Responsible Party: CISL (Consortium to Improve Lymphoma Survival)
ClinicalTrials.gov Identifier: NCT00418535     History of Changes
Other Study ID Numbers: 2004-10-08
Study First Received: January 3, 2007
Last Updated: October 20, 2009
Health Authority: Korea: Food and Drug Administration

Keywords provided by Samsung Medical Center:
Lymphoma, NK/T-Cell

Additional relevant MeSH terms:
Lymphoma, T-Cell
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on October 01, 2014