Study on the Combination Regimen of Dexamethasone Ifosfamide Cisplatin Etoposide in Patients With NK/T Cell Lymphoma
NCT ID: NCT00568607
Last Updated: 2010-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2007-03-31
2010-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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IFO, VP-16, DDP, DXM
IFO, VP-16, DDP, DXM
DXM 40 mg d1-4; IFO 1200mg/m2 d1-4; Mesna 400mg, tid, d1-4; VP-16 75 mg/m2 d1-4; DDP 20mg/m2 d1-4; q3w. Efficacy was evaluated every two cycles. If patients hadn't diseases progression, two more cycles and radiation would be administered.
Interventions
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IFO, VP-16, DDP, DXM
DXM 40 mg d1-4; IFO 1200mg/m2 d1-4; Mesna 400mg, tid, d1-4; VP-16 75 mg/m2 d1-4; DDP 20mg/m2 d1-4; q3w. Efficacy was evaluated every two cycles. If patients hadn't diseases progression, two more cycles and radiation would be administered.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histological confirmed NK/T cell lymphoma
* ECOG performance status less than 2
* Life expectancy of more than 3 months
* None of major drugs in the trial (IFO,VP16,DDP) has been previously used
* Normal laboratory values: hemoglobin \> 80 g/dl, neutrophil \> 2×109/L, platelet \> 100×109/L, serum creatine \< 1.5×upper limitation of normal (ULN), serum bilirubin \< 1.5×ULN, ALT and AST \< 2.5×ULN
Exclusion Criteria
* Serious uncontrolled diseases and intercurrent infection
* The evidence of CNS metastasis
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
18 Years
75 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Fudan University Cancer Hospital
Principal Investigators
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Ye Guo, M.D.
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DICE-NK/T
Identifier Type: -
Identifier Source: org_study_id