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

This study has been completed.
Sponsor:
Information provided by:
ARCAGY/ GINECO GROUP
ClinicalTrials.gov Identifier:
NCT00517621
First received: August 16, 2007
Last updated: February 24, 2011
Last verified: February 2011
History of Changes
  Purpose

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 Intervention Phase
Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Neoplasms
 Drug: Paclitaxel
Drug: EPO
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Drug Information available for: Paclitaxel
U.S. FDA Resources

Further study details as provided by ARCAGY/ GINECO GROUP:

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

Estimated Enrollment: 100
Study Start Date: February 2006
Study Completion Date: October 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00517621

Locations
France
HOTEL DIEU Hospital
Paris, France
Sponsors and Collaborators
ARCAGY/ GINECO GROUP
Investigators
Principal Investigator: Laure COPEL, Physician Institut CURIE - PARIS
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00517621     History of Changes
Other Study ID Numbers: ETAMINE
Study First Received: August 16, 2007
Last Updated: February 24, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on May 22, 2013