EWOC-1 (Elderly Women Ovarian Cancer) Trial: Multicenter, randomized trial of carboplatin +/- paclitaxel in vulnerable elderly patients with stage III-IV advanced ovarian cancer.

Conditions: Advanced ovarian cancer
MedDRA version: 18.1Level: PTClassification code 10070908Term: Ovarian cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 18.1Level: PTClassification code 10070907Term: Ovarian cancer stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2013-000266-11-FI

Lead Sponsor: Hospices Civils de Lyon

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 240

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.