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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00517621
Recruitment Status : Completed
First Posted : August 17, 2007
Last Update Posted : February 25, 2011
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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.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Fallopian Tube Cancer Peritoneal Neoplasms Drug: Paclitaxel Drug: EPO Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2006
Actual Primary Completion Date : September 2010
Actual Study Completion Date : October 2010

Primary Outcome Measures :
  1. Validation of a french version of FACT-GOG/NTX of peripheral neurotoxicity questionnaire

Secondary Outcome Measures :
  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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00517621

Paris, France
Sponsors and Collaborators
Principal Investigator: Laure COPEL, Physician Institut Curie Paris Identifier: NCT00517621     History of Changes
Other Study ID Numbers: ETAMINE
First Posted: August 17, 2007    Key Record Dates
Last Update Posted: February 25, 2011
Last Verified: February 2011

Keywords provided by ARCAGY/ GINECO GROUP:
Peritoneal cancer
Relapse or progression

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Neurotoxicity Syndromes
Peritoneal Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Nervous System Diseases
Chemically-Induced Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action