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Sponsored by: |
ARCAGY/ GINECO GROUP |
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Information provided by: | ARCAGY/ GINECO GROUP |
ClinicalTrials.gov Identifier: | NCT00517621 |
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 II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment |
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 |
Estimated Enrollment: | 100 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | December 2008 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Esther Plançon, Project mngr | +33 1 42 34 83 23 | eplancon@arcagy.org |
France | |
HOTEL DIEU Hospital | Recruiting |
Paris, France | |
Contact: Laure COPEL, Physician +33 1 44 32 43 49 |
Principal Investigator: | Laure COPEL, Physician | Institut CURIE - PARIS |
Study ID Numbers: | ETAMINE |
Study First Received: | August 16, 2007 |
Last Updated: | August 16, 2007 |
ClinicalTrials.gov Identifier: | NCT00517621 History of Changes |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Peritoneal cancer Relapse or progression |
Fallopian Tube Cancer Neurotoxicity Syndromes Gonadal Disorders Disease Progression Urogenital Neoplasms Ovarian Diseases Genital Diseases, Female Peritoneal Diseases Ovarian Cancer Endocrine Gland Neoplasms Ovarian Neoplasms Digestive System Neoplasms Genital Neoplasms, Female |
Endocrine System Diseases Antimitotic Agents Abdominal Neoplasms Fallopian Tube Neoplasms Fallopian Tube Diseases Digestive System Diseases Paclitaxel Tubulin Modulators Gastrointestinal Neoplasms Peritoneal Neoplasms Endocrinopathy Antineoplastic Agents, Phytogenic |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gonadal Disorders Urogenital Neoplasms Ovarian Diseases Genital Diseases, Female Neoplasms by Site Therapeutic Uses Peritoneal Diseases Endocrine Gland Neoplasms Ovarian Neoplasms Digestive System Neoplasms Mitosis Modulators Genital Neoplasms, Female |
Endocrine System Diseases Antimitotic Agents Abdominal Neoplasms Fallopian Tube Neoplasms Pharmacologic Actions Adnexal Diseases Fallopian Tube Diseases Neoplasms Digestive System Diseases Paclitaxel Tubulin Modulators Peritoneal Neoplasms Antineoplastic Agents, Phytogenic |