Advanced ovarian cancer MedDRA version: 18.0 Level: PT Classification code 10070908 Term: Ovarian cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 18.0 Level: PT Classification code 10070907 Term: Ovarian cancer stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: CARBOPLATIN
Other descriptive name: CARBOPLATIN
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentratio
Sponsors
Hospices Civils de Lyon
Eligibility
Sex/Gender
All
Inclusion criteria
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 14, albuminemia 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the success rate of 3 different chemotherapy regimens in women > 70 with ovarian cancer stage III-IV, considered as vulnerable upon defined Geriatric Vulnerability Score (GVS). Success is defined as the ability to deliver to patients 6 courses of chemotherapy without premature termination for progression, death or unacceptable toxicity.;Secondary Objective: - Therapeutical strategy (feasibility of performing an optimal surgery and feasibility of performing neoadjuvant chemotherapy and surgery and post operative chemotherapy until 6 courses) - Interval debulking feasibility - Post-operative chemotherapy feasibility - Progression-free Survival (PFS) - Overall Survival (OS) - Quality of life (QOL) - Safety and tolerability - Geriatric covariates and patient outcome ;Primary end point(s): Success rate of delivering one of the 3 different chemotherapy regimens Treatment success is defined as the ability to deliver 6 courses of chemotherapy without premature termination for progression, death or unacceptable toxicity. ;Timepoint(s) of evaluation of this end point: After 6 courses of chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Therapeutical strategy Therapeutical strategy will be assessed by measuring the feasibility of performing an optimal surgery and feasibility of performing neoadjuvant chemotherapy and surgery and post operative chemotherapy until 6 courses in case of planned interval debulking surgery. Interval debulking surgery feasibility and post-operative chemotherapy will also be assessed. 2) Overall Survival Overall survival will be analyzed on going by Kaplan-Meier method and will be estimated at 1 and 2 years (data points) for each treatment arm. Overall survival will be measured from date of randomization to death from any cause or the date of last contact (censored data). An univariate analysis will be performed using the log-rank technique to determine the prognostic role geriatric covariates and aging biomarkers. The adjusted prognostic value will be estimated in a multivariate analysis using a cox proportional hazards model. 3) Geriatric assessment and biological covariates For the study of geriatric covariates - Analysis of covariates of the geriatric assessment (percentages). - Estimation of the correlation between the parameters of the geriatric assessment and treatment toxicity, tumor response, overall survival and progression-free survival (correlation tests). Geriatric covariates distribution, by type and by patient as well as baseline biological values will be described and presented for each treatment arm in tables. 4) Safety, feasibility and efficacy of chemotherapy related covariates - Feasibility of six courses of chemotherapy The proportion of patients who completed 6 courses will be presented for each treatment arm with its confidence interval. The possible impact of geriatric prognostic factors will be estimated using a logistic regression (multivariate analysis). - Chemotherapy related toxicity Analysis of toxicities related to chemotherapy, which will be collected for each treatment and scored according to N | — |
Countries
Canada, Denmark, Finland, France, Germany, Ireland, Italy, Japan, Norway, Sweden
Contacts
Public ContactKathleen Scott
ICORG
Outcome results
None listed