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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00517621
• Other study ID #: ETAMINE
• Status: Completed
• Phase: Phase 2
• First received: August 16, 2007
• Last updated: February 24, 2011
• Start date: February 2006
• Est. completion date: October 2010

Study information

• Verified date: February 2011
• Source: ARCAGY/ GINECO GROUP
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Neurotoxicity Syndromes
• Ovarian Cancer
• Ovarian Neoplasms
• Peritoneal Neoplasms

Intervention

Drug:
• Paclitaxel

• EPO

Locations

Country	Name	City	State
France	HOTEL DIEU Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
ARCAGY/ GINECO GROUP

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validation of a french version of FACT-GOG/NTX of peripheral neurotoxicity questionnaire
Secondary	- incidence and severity of the peripheral neurotoxicity according to whether the patients are treated or not by EPO
Secondary	- variation of the rate of haemoglobin during chemotherapy
Secondary	- Incidence of the thrombo-embolic events according to whether the patients are treated or not by EPO