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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2010-10-31

Brief Summary

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validation of a french version of FACT-GOG/NTX and using this questionnaire to evaluate the incidence of the peripheral neurotoxicity in patients treated for ovarian cancer with paclitaxel associated or not with EPO.

Detailed Description

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Conditions

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Ovarian Cancer Fallopian Tube Cancer Peritoneal Neoplasms

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Paclitaxel

Intervention Type DRUG

EPO

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Femal patient aged \> 18 years
* 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

* peripheral neuropathy grade \> 2
* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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ARCAGY/ GINECO GROUP

OTHER

Sponsor Role lead

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

Site Status

Countries

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France

Other Identifiers

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ETAMINE

Identifier Type: -

Identifier Source: org_study_id

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