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

Sponsor
Samsung Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00418535
Collaborator
Korea University Anam Hospital (Other), Asan Medical Center (Other), Gyeongsang National University Hospital (Other)
1
Location
39
Duration (Months)

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Drug: Concurrent Radiotherapy (RT)/cisplatin, VIPD
 Phase 2

Study Design

Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date :
Apr 1, 2006
Actual Primary Completion Date :
Mar 1, 2009
Actual Study Completion Date :
Jul 1, 2009

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00418535
    Other Study ID Numbers:
    • 2004-10-08
    First Posted:
    Jan 5, 2007
    Last Update Posted:
    Oct 21, 2009
    Last Verified:
    Jan 1, 2007
    Keywords provided by , ,
    Lymphoma, NK/T-Cell
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, T-Cell
    Cisplatin

    Study Results

    No Results Posted as of Oct 21, 2009