Two Therapeutic Strategies in First-line in Patients With Epithelial Advanced Ovarian Cancer
Phase 2
Recruiting
- Conditions
- Ovarian Cancer, Epithelial
- Interventions
- Drug: CC0 - Carboplatin (IV) - Paclitaxel (IV)Drug: CC>0 - Carboplatin (IV)- Paclitaxel (IV)
- Registration Number
- NCT03025477
- Lead Sponsor
- Groupe Hospitalier Diaconesses Croix Saint-Simon
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 84
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental arm CC0 - Cisplatin (IP) - Epirubicin (IV) Initial or interval surgery associated with 6 cycles of chemotherapy of cisplatin and epirubicin. * Cisplatin is administrated in intraperitoneal (IP) if no macroscopic residual tumor at the end of the intervention (initial or interval). If evidence of macroscopic residual tumor, cisplatin is administered in IV. Epirubicin is always given in IV. * Second cytoreduction surgery at mid-term of chemotherapy cycles, only in patients operable in response after 3 cycles and with persistent residual disease after initial surgery or incomplete initial staging. The regimen of administration of the chemotherapy is as following: * Cisplatin 80mg / m² - IV or IP - D1 * Epirubicin 60mg / m² - IV - D3 one Cycle every 3 weeks. Experimental arm CC>0 - Cisplatin (IP/IV)- Epirubicin (IV) Initial or interval surgery associated with 6 cycles of chemotherapy of cisplatin and epirubicin. * Cisplatin is administrated in intraperitoneal (IP) if no macroscopic residual tumor at the end of the intervention (initial or interval). If evidence of macroscopic residual tumor, cisplatin is administered in IV. Epirubicin is always given in IV. * Second cytoreduction surgery at mid-term of chemotherapy cycles, only in patients operable in response after 3 cycles and with persistent residual disease after initial surgery or incomplete initial staging. The regimen of administration of the chemotherapy is as following: * Cisplatin 80mg / m² - IV or IP - D1 * Epirubicin 60mg / m² - IV - D3 one Cycle every 3 weeks. Control arm CC0 - Carboplatin (IV) - Paclitaxel (IV) Initial or interval surgery associated with 6 cycles of chemotherapy in intravenous (IV) of carboplatin and paclitaxel. The regimen of administration of the chemotherapy is as following: * Carboplatin AUC 6 - IV - Day (D) 1 * Paclitaxel 80mg / m² - IV - D1, D8, D15 one cycle every 3 weeks Control arm CC>0 - Carboplatin (IV)- Paclitaxel (IV) Initial or interval surgery associated with 6 cycles of chemotherapy in intravenous (IV) of carboplatin and paclitaxel. The regimen of administration of the chemotherapy is as following: * Carboplatin AUC 6 - IV - Day (D) 1 * Paclitaxel 80mg / m² - IV - D1, D8, D15 one cycle every 3 weeks
- Primary Outcome Measures
Name Time Method Pathological complete peritoneal response (pCR) 2-year Interval debulking surgery or final evaluation peritoneal surgery
- Secondary Outcome Measures
Name Time Method IPSS score 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 Quality of life (QLQ -C30) assessment Up to 2-year (at inclusion, after 3 cycles and end of treatment) Quality of life (QLQ-OV28) assessment 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 Overall survival (OS) At 5-year and 10-year Event-free survival (EFS) At 5-year and 10-year
Trial Locations
- Locations (7)
Centre Georges François Leclerc
🇫🇷Dijon, France
Groupe Hospitalier Diaconesses Croix Saint Simon
🇫🇷Paris, France
Institut Hospitalier Franco-Britannique
🇫🇷Levallois-Perret, France
Hôpital Saint Antoine
🇫🇷Paris, France
Hôpital Poissy Saint Germain
🇫🇷Poissy, France
CHU Poitiers
🇫🇷Poitiers, France
Centre Hospitalier Senlis
🇫🇷Senlis, France