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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00517621

Enrollment

100

Registered

2007-08-17

Start date

2006-02-28

Completion date

2010-10-31

Last updated

2011-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms

Keywords

Peritoneal cancer, Relapse or progression

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.

Interventions

DRUGPaclitaxel

DRUGEPO

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Validation of a french version of FACT-GOG/NTX of peripheral neurotoxicity questionnaire	—

Secondary

Measure	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	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026