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

Primary Purpose

Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Paclitaxel
EPO
Sponsored by
ARCAGY/ GINECO GROUP
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring Peritoneal cancer, Relapse or progression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • HOTEL DIEU Hospital

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

- 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

Full Information

First Posted
August 16, 2007
Last Updated
February 24, 2011
Sponsor
ARCAGY/ GINECO GROUP
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1. Study Identification

Unique Protocol Identification Number
NCT00517621
Brief Title
Use of FACT-GOG/NTX Questionnaire in Peripheral Neurotoxicity & Validation of a French Version of This Questionnaire
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
ARCAGY/ GINECO GROUP

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms
Keywords
Peritoneal cancer, Relapse or progression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Type
Drug
Intervention Name(s)
EPO
Primary Outcome Measure Information:
Title
Validation of a french version of FACT-GOG/NTX of peripheral neurotoxicity questionnaire
Secondary Outcome Measure Information:
Title
- incidence and severity of the peripheral neurotoxicity according to whether the patients are treated or not by EPO
Title
- variation of the rate of haemoglobin during chemotherapy
Title
- Incidence of the thrombo-embolic events according to whether the patients are treated or not by EPO

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laure COPEL, Physician
Organizational Affiliation
Institut Curie Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
HOTEL DIEU Hospital
City
Paris
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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