Skip to main content
OpenTrials
Completed

NCT Number: NCT00517621

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ovarian Cancer Abdominal Neoplasms Adnexal Diseases Digestive System Diseases Digestive System Neoplasms Disease Attributes Disease Progression Endocrine Gland Neoplasms Endocrine System Diseases Fallopian Tube Cancer Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Peritoneal Diseases Peritoneal Neoplasms Recurrence Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

HOTEL DIEU Hospital

Paris, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

paclitaxel

Drug

EPO

Drug

Primary outcomes

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

Secondary outcomes

  1. - incidence and severity of the peripheral neurotoxicity according to whether the patients are treated or not by EPO

  2. - variation of the rate of haemoglobin during chemotherapy

  3. - Incidence of the thrombo-embolic events according to whether the patients are treated or not by EPO

Sponsors and collaborators

Lead sponsor

ARCAGY/ GINECO GROUP

Other

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Aug 17, 2007
Registry last updated
Feb 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.