Status:
COMPLETED
Clinical Study of Chemoradiation Followed by VIPD in Nasal Natural Killer (NK)/T-cell Lymphoma
Lead Sponsor:
Samsung Medical Center
Collaborating Sponsors:
Korea University Anam Hospital
Asan Medical Center
Conditions:
Lymphoma, T-Cell
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
End Date :
July 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00418535
Start Date
April 1 2006
End Date
July 1 2009
Last Update
October 21 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Samsung Medical Center
Seoul, South Korea, 135-710