- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00517621
Use of FACT-GOG/NTX Questionnaire in Peripheral Neurotoxicity & Validation of a French Version of This Questionnaire
February 24, 2011 updated by: ARCAGY/ GINECO GROUP
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
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Paris, France
- Hotel Dieu Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Validation of a french version of FACT-GOG/NTX of peripheral neurotoxicity questionnaire
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Secondary Outcome Measures
Outcome Measure |
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- incidence and severity of the peripheral neurotoxicity according to whether the patients are treated or not by EPO
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- variation of the rate of haemoglobin during chemotherapy
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- Incidence of the thrombo-embolic events according to whether the patients are treated or not by EPO
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Laure COPEL, Physician, Institut Curie Paris
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2006
Primary Completion (ACTUAL)
September 1, 2010
Study Completion (ACTUAL)
October 1, 2010
Study Registration Dates
First Submitted
August 16, 2007
First Submitted That Met QC Criteria
August 16, 2007
First Posted (ESTIMATE)
August 17, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
February 25, 2011
Last Update Submitted That Met QC Criteria
February 24, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Chemically-Induced Disorders
- Digestive System Diseases
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Peritoneal Diseases
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Digestive System Neoplasms
- Endocrine Gland Neoplasms
- Fallopian Tube Diseases
- Abdominal Neoplasms
- Poisoning
- Ovarian Neoplasms
- Fallopian Tube Neoplasms
- Peritoneal Neoplasms
- Carcinoma, Ovarian Epithelial
- Neurotoxicity Syndromes
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
Other Study ID Numbers
- ETAMINE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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