Use of FACT-GOG/NTX Questionnaire in Peripheral Neurotoxicity & Validation of a French Version of This Questionnaire

Phase 2

Completed

• Conditions: Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Neoplasms

• Registration Number: NCT00517621
• Lead Sponsor: ARCAGY/ GINECO GROUP

Brief Summary

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

Not available

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2007-08-16
• Study First Submitted QC: 2007-08-16
• Study First Posted: 2007-08-17
• Primary Completion: 2010-09
• Study Completion: 2010-10
• Status Verified: 2011-02
• Last Update Submitted: 2011-02-24
• Last Update Posted: 2011-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Validation of a french version of FACT-GOG/NTX of peripheral neurotoxicity questionnaire

Secondary Outcome Measures

Name	Time	Method
- incidence and severity of the peripheral neurotoxicity according to whether the patients are treated or not by EPO
- variation of the rate of haemoglobin during chemotherapy
- Incidence of the thrombo-embolic events according to whether the patients are treated or not by EPO

Trial Locations

Locations (1)

HOTEL DIEU Hospital; 🇫🇷 Paris, France