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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Laure COPEL, Physician

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut CURIE - PARIS

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

ETAMINE

NCT ID:

NCT00517621

Start Date:

February 2006

Completion Date:

October 2010

Related Keywords:

  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Peritoneal Neoplasms
  • Peritoneal cancer
  • Relapse or progression
  • Neoplasms
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms
  • Neurotoxicity Syndromes

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