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

Hospices Civils de Lyon0 个研究点目标入组 240 人开始时间: 2015年9月11日最近更新: 2020年12月7日

适应症

试验速览

暂无简介。

•- 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

•- 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.

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