Status:
COMPLETED
A Phase II Study of Nasal NK/T-cell Lymphoma
Lead Sponsor:
National Health Research Institutes, Taiwan
Collaborating Sponsors:
Mackay Memorial Hospital
National Cheng-Kung University Hospital
Conditions:
Lymphoma
Eligibility:
All Genders
Up to 70 years
Phase:
PHASE2
Brief Summary
To determine whether adding combinational chemotherapy concurrently to conventional radiation will improve the response rate, event-free survival, and overall survival. To test the dose intensity and...
Detailed Description
Inclusion Criteria: 1. Histologically proven extranodal NK/T-cell lymphoma, nasal type according to the WHO classification (must be pathology-proven EBV DNA positive as well as cytoplasmic CD3 +, whi...
Eligibility Criteria
Inclusion
- Histologically proven extranodal NK/T-cell lymphoma, nasal type according to the WHO classification (must be pathology-proven EBV DNA positive as well as cytoplasmic CD3 +, while CD56+ is not an essential diagnostic criteria. ). Newly diagnosed patients.
- Any of lymphomatous involvement exist in nasal cavity and/or paranasal sinuses, orbit, Waldeyer's ring, and oral cavity performance status with ECOG scale 0-2.
- Stage I or contiguous stage II, measurable or evaluable lymphoma by clinical imaging No previous chemotherapy and/or radiotherapy.
- ANC ≧ 2,000/mm3, Platelet ≧ 100,000/mm3 of peripheral blood.
- Age \<70.
- Total bilirubin \< 2.5 mg/dl, Serum creatinine ≦1.5 mg/dl, Blood urea nitrogen (BUN) ≦ 25 mg/dl
Exclusion
- Pregnancy or lactation period 2.Severe intercurrent illness, eg. Infection, heart failure 3.Myocardial infarction within recent 12 months 4.Known hypersensitivity to any component drug of the treatment regimen
- \-
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT00292695
Start Date
May 1 2006
End Date
December 1 2010
Last Update
October 30 2013
Active Locations (1)
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1
National Health Research Institutes, Lymphoma Disease Committee
Taipei, Taiwan