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Main
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Note: This record shows only 22 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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19 February 2015 |
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Main ID: |
NCT00536393 |
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Date of registration:
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26/09/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Treatment of Disseminated High Grade Lymphoma
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Scientific title:
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Phase III Study of Treatment of Disseminated and Agressive Lymphoma R CHOP Versus R CLOP( With Liposomal Doxorubicin) |
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Date of first enrolment:
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October 2000 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00536393 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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France
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Contacts
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Name:
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Guillaume CARTRON, Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- high grade lymphoma
- disseminated
- > 60 years old and < 75
- informed consent signed
- cardiac state compatible with antracyclin
- ECOG
Exclusion Criteria:
- patients > 75 years old
- Cardiac insufficiency
Age minimum:
60 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: Doxorubicin
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Drug: Doxorubicin pegylated
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Primary Outcome(s)
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hematologic toxicity
[Time Frame: 6 months]
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Secondary Outcome(s)
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response rate
[Time Frame: 6 months]
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Cardiac toxicity
[Time Frame: 6 months]
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EFS and OS
[Time Frame: 6 months]
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Secondary ID(s)
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GOELAMS 0804
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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