EUCTR2013-000266-11-FIActive, not recruitingNot Applicable
EWOC-1 (Elderly Women Ovarian Cancer) Trial: Multicenter, randomized trial of carboplatin +/- paclitaxel in vulnerable elderly patients with stage III-IV advanced ovarian cancer. - EWOC-1
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 240
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •- Woman >70 year old: a patient can be included the day after her 70th birthday.
- •- Histologically or cytologically proven FIGO stage III to IV epithelial ovarian cancer or peritoneal primary or fallopian tube. A cytological proof is accepted if associated with a ratio of CA125/CEA >25 and a radiological pelvic mass.
- •- GVS (Geriatric Vulnerability Score) >3. GVS is the sum of geriatric covariates scores found to predict poor survival: ADL score <6; IADL score <25, HADS score >14, albuminemia <35g/L and lymphopenia <1G/L.
- •- Adequate bone marrow function including the following:
- •Neutrophils = 1.5 x 109/L, platelets =100 x 109/L and hemoglobin = 9 g/dL.
- •- Adequate glomerular filtration rate >40 ml/min (estimates based on MDRD or CKD-EPI formula are sufficient)
- •- No icterus.
- •- Life expectancy > 3 months.
- •- Written informed consent obtained
- •- Covered by a Health System where applicable
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 240
Exclusion Criteria
- •- Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer
- •- Prior history of chemotherapy for the present malignancy
- •- Prior history of radiotherapy which may affect patient tolerability to chemotherapy
- •- Major perturbations of liver biology: Bilirubin >2 fold the upper normal limit (UNL) , SGOT-SGPT > 3 fold UNL.
- •- Patient unable to be regularly followed for any reason (geographic, familial, social, psychologic).
- •- Any mental or physical handicap at risk of interfering with the appropriate treatment.
- •- Known allergy to Cremophor ® EL -containing drugs
- •- Any administrative or legal supervision where applicable.
Investigators
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