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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00568607 |
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Date of registration:
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05/12/2007 |
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Primary sponsor: |
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Public title:
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Study on the Combination Regimen of Dexamethasone Ifosfamide Cisplatin Etoposide in Patients With NK/T Cell Lymphoma
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Scientific title:
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Phase II Study of a Combination Chemotherapy of DICE in the Patients With NK/T Cell Lymphoma |
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Date of first enrolment:
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March 2007 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00568607 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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China
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Contacts
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Name:
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Biyun Wang, MD |
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Address:
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Telephone:
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8613701748410 |
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Email:
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wangbiyun@msn.com |
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Affiliation:
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Name:
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Ye Guo, MD |
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Address:
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Telephone:
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862164175590 |
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Email:
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pattrick_guo@msn.com |
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Affiliation:
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Name:
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Ye Guo, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Fudan University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age range 18-75 years old
- 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:
- Pregnant or lactating women
- 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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Lymphoma
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Intervention(s)
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Drug: IFO, VP-16, DDP, DXM
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Primary Outcome(s)
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Response rate
[Time Frame: every two cycles]
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Secondary Outcome(s)
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TTP and OS
[Time Frame: every two cycles]
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Secondary ID(s)
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DICE-NK/T
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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