Use of FACT-GOG/NTX Questionnaire in Peripheral Neurotoxicity & Validation of a French Version of This Questionnaire
NCT ID: NCT00517621
Last Updated: 2011-02-25
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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COMPLETED
PHASE2
100 participants
INTERVENTIONAL
2006-02-28
2010-10-31
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
Interventions
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Paclitaxel
EPO
Eligibility Criteria
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Inclusion Criteria
* Histologically proven diagnosis of cancer of the ovary, the fallopian tube or peritoneal
* patients whose disease progresses or relapses
* patients having received at least a line of platinum-based chemotherapy
* patients whose treatment of relapse is envisaged to comprise paclitaxel
* patients who will receive EPO for treatment of their anaemia
* ECOG performans status \< 2
* life expectancy \> 16 weeks
* patient who has clearly given her consent by signing on informed consent form prior to participation
Exclusion Criteria
* history of ischemic cardiopathy, congestive heart failure (NYHA\>2), arrhythmia, hypertension or significant valvulopathy
* abnormal biological values
* A therapy or a serious disease which could involve a risk for the patient or interfere with the aims of the study
* patient who is pregnant, breast feeding or using inadequate contraception
* concomitant therapy by a potentially neurotoxic drug
* concomitant inclusion in another therapeutic trial which could interfere with the aims of the study
* patient who for familial, sociological, geographical or psychological condition could not be followed correctly
18 Years
FEMALE
No
Sponsors
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ARCAGY/ GINECO GROUP
OTHER
Principal Investigators
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Laure COPEL, Physician
Role: PRINCIPAL_INVESTIGATOR
Institut Curie Paris
Locations
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HOTEL DIEU Hospital
Paris, , France
Countries
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Other Identifiers
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ETAMINE
Identifier Type: -
Identifier Source: org_study_id
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