Patients with First or second recurrence of platin-resistant epithelial ovarian cancer MedDRA version: 20.0 Level: PT Classification code 10033128 Term: Ovarian cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: CISPLATINE ACCORD
Product Name: cisplatine
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CISPLATIN
Other descriptive name: CISPLATINE
Concentration unit: mg/ml milligram
Sponsors
Hospices Civils de Lyon
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 18 3,500/mm3, neutrophils =1,500/mm3, platelets =100,000/mm3; - Good renal function: CKD-EPI >60 ml/min/1.73 m²; - Eastern Cooperative Oncology Group Performance Status (ECOG PS) =2; - Serum bilirubin =1.5 x Upper Limit of Normal (ULN); - Prior debulking surgery whatever the residue - Information on the residue of the debulking surgery available (R0 or R+) - Treated with a maximum of two previous lines of chemotherapy - Covered by a Healthcare System; - Signed written informed consent obtained prior to any study-specific screening procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: - Platinum-refractory EOC (i.e. progression under platinum containing chemotherapy); - History of breast cancer or previous malignancies not considered in complete remission for at least 2 years; - Pregnant or lactating females. Serum pregnancy test to be assessed within 7 days prior to study treatment start, or within 14 days (with a confirmatory urine pregnancy test within 7 days prior to study treatment start); - Women of childbearing potential (defined as <2 years after last menstruation and not surgically sterile) not using highly-effective, hormonal or non-hormonal means of contraception (i.e. intrauterine contraceptive device) during the study and for 6 months after the last dose of study medication; - Untreated central nervous system disease or symptomatic central nervous system metastasis; - History or evidence of thrombotic or haemorrhagic disorders within 6 months before first study treatment; - Uncontrolled hypertension (sustained systolic = 140 mmHg and/or diastolic = 90 mmHg confirmed by 2 measures despite antihypertensive therapy) or clinically significant (i.e. active) cardiovascular disease;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the progression-free survival at 36 months between patients treated with CRS + HIPEC combined with perioperative monochemotherapy ± bevacizumab (“Chemotherapy + CRS + HIPEC” Group) and patients treated with monochemotherapy ± bevacizumab alone (“Exclusive Chemotherapy” Group). ;Secondary Objective: Efficacy: - To compare the Overall Survival (OS) between study groups. - To compare the progression-free survival based on tumour thickness at 36 months between patients treated with CRS + HIPEC combined with perioperative monochemotherapy ± bevacizumab and patients treated with monochemotherapy ± bevacizumab alone. Safety: - To describe the safety and tolerability of the study treatments for each group - To describe surgical complications for “Chemotherapy + CRS + HIPEC” group. Quality of Life: - To compare the quality of life as assessed by the Functional Assessment of Cancer Therapy-Ovarian (FACT-O) between study groups. ;Primary end point(s): Progression-Free Survival (PFS) defined as the time interval between the date of randomization and the first radiologically documented disease progression or death, whichever occurs first.;Timepoint(s) of evaluation of this end point: 36 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Overall survival will be measured from the date of randomization to the date of death (irrespective of cause). Patients who are not dead at the end of the study will be right censored at the most recent date known to be alive. - PFS based on tumour thickness defined as the time interval between the date of randomization and the first radiologically documented disease progression or death, whichever occurs first. Disease progression will be based on modified RECIST criteria previously used in malignant pleural mesothelioma response assessment assessed by thoraco-abdominopelvic CT (or PET with iodinated contrast) scan. ;Timepoint(s) of evaluation of this end point: 36 months | — |
Countries
France
Contacts
Public ContactSylvie GALVAIN
hospices Civils de Lyon
Outcome results
None listed