Ovarian Cancer, Epithelial
Conditions
Keywords
Intraperitoneal, Intravenous, Completeness of cytoreduction score, Carboplatin, Epirubicin, Paclitaxel, Cisplatin
Brief summary
CHIMOVIP is a study to determine the best therapeutic strategy in patient with ovarian advanced cancer.
Detailed description
This is a randomized phase II study, open-label and multicentric. After initial intervention (debulking surgery or diagnostic surgery) patient will randomized in the study according to Completeness of cytoreduction (CC) score (CC0 or CC\>1).
Interventions
DRUGCC0 - Carboplatin (IV) - Paclitaxel (IV)
(6 cycles)
DRUGCC0 - Cisplatin (IP) - Epirubicin (IV)
(6 cycles)
DRUGCC>0 - Carboplatin (IV)- Paclitaxel (IV)
* carboplatin (IV) - paclitaxel (IV) (3 cycles) * Interval surgery * Carboplatin (IV) - paclitaxel (IV) (3 cycles)
DRUGCC>0 - Cisplatin (IP/IV)- Epirubicin (IV)
* Cisplatin (IV) - Epirubicin (IV) (3 cycles) * Interval surgery : * if CC0: Cisplatin (IP) - Epirubicin (IV) (3 cycles) * if CC\>0 Cisplatin (IV)- Epirubicin (IV) (3 cycles)
Sponsors
GERCOR - Multidisciplinary Oncology Cooperative Group
Groupe Hospitalier Diaconesses Croix Saint-Simon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed advanced (FIGO stage III or IV) invasive epithelial ovarian cancer, primary peritoneal cancer, or fallopian-tube cancer. Pleural cytology has to be performed in patients with pleural effusion. * Initial intervention : debulking surgery or diagnostic surgery in the 3 weeks before inclusion * Age ≥18 and \< 75 years old. * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 before surgery (ECOG ≤ 1 and Lee score \< 6 in patients \> 70 years old). * Adequate blood count (test realized in the past 14 days before inclusion) : neutrophils \> 1500/mm3, platelets \> 150 000/mm3. * Creatinine clearance MDRD ≥ 60 mL/min * Registration in a national health care system (CMU included). * Signed and dated informed consent.
Exclusion criteria
* FIGO stage IV extra-abdominal disease, with the exception of lymph nodes and pleural invasion. * Patient having received previous chemotherapy for ovarian cancer. * Left ventricular ejection fraction \< 50% before chemotherapy initiation * Other invasive cancer in the past 5 years (baso- and spinocellular cutaneous carcinoma with complete resection are accepted) * Concomitant administration of prophylactic phenytoin or live attenuated viral vaccines such as yellow fever vaccine, * Patients with known hypersensitivity to any component of study drug * Patients without motivation or capacity to respect study requirements and constraints * Pregnancy or breast feeding women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological complete peritoneal response (pCR) | 2-year | Interval debulking surgery or final evaluation peritoneal surgery |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life (QLQ-OV28) assessment | Up to 2-year (at inclusion, after 3 cycles and end of treatment) |
| IPSS score | Up to 2-year (at inclusion, after 3 cycles and end of treatment) |
| Number of patients with treatment-related adverse events as assessed by CTCAE version 4.03 | 2-year |
| Quality of life (QLQ -C30) assessment | Up to 2-year (at inclusion, after 3 cycles and end of treatment) |
| Objective response rate at the various surgical step | Up to 2-year |
| Overall survival (OS) | At 5-year and 10-year |
| Event-free survival (EFS) | At 5-year and 10-year |
Countries
France
Contacts
Primary ContactRichard VILLET, MD
Backup ContactDelphine COCHEREAU, MD
Outcome results
None listed