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

ARCAGY/ GINECO GROUP

Status and phase

Completed

Phase 2

Conditions

Peritoneal Neoplasms

Fallopian Tube Cancer

Ovarian Cancer

Treatments

Drug: EPO

Drug: Paclitaxel

Study type

Interventional

Funder types

Other

Identifiers

NCT00517621

ETAMINE

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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