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

Study Overview
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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.

Official Title
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A Multicenter Prospective Phase II Study Evaluating Peripheral Neurotoxicity by Using FACT-GOG/NTX Questionnaire in Patients With Ovarian Cancer in Relapse Treated by Paclitaxel +/- EPO. Validation of a French Version of This Questionnaire

Conditions
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Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms

Intervention / Treatment
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* Drug: Paclitaxel
* Drug: EPO


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Paclitaxel|nan|
|Drug: EPO|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of a french version of FACT-GOG/NTX of peripheral neurotoxicity questionnaire |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peritoneal cancer, Relapse or progression