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

Primary Purpose

Lymphoma, T-Cell

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Concurrent Radiotherapy (RT)/cisplatin, VIPD
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, T-Cell focused on measuring Lymphoma, NK/T-Cell

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 3, 2007
Last Updated
October 20, 2009
Sponsor
Samsung Medical Center
Collaborators
Korea University Anam Hospital, Asan Medical Center, Gyeongsang National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00418535
Brief Title
Clinical Study of Chemoradiation Followed by VIPD in Nasal Natural Killer (NK)/T-cell Lymphoma
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 Type
Interventional

2. Study Status

Record Verification Date
January 2007
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Samsung Medical Center
Collaborators
Korea University Anam Hospital, Asan Medical Center, Gyeongsang National University Hospital

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, T-Cell
Keywords
Lymphoma, NK/T-Cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Concurrent Radiotherapy (RT)/cisplatin, VIPD

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Won Seog Kim, MD, Ph.D
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

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

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