Clinical trial · Interventional
Use of FACT-GOG/NTX Questionnaire in Peripheral Neurotoxicity & Validation of a French Version of This Questionnaire
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
NCT00517621CI-TRIAL-00004469completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fallopian Tube Cancer | Malignant Fallopian Tube Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Peritoneal Neoplasms | Peritoneal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EPO | Drug | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Validation of a french version of FACT-GOG/NTX of peripheral neurotoxicity questionnaire
Secondary outcomes (3)
- measure
- - incidence and severity of the peripheral neurotoxicity according to whether the patients are treated or not by EPO
- measure
- - variation of the rate of haemoglobin during chemotherapy
- measure
- - Incidence of the thrombo-embolic events according to whether the patients are treated or not by EPO
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.