Two Therapeutic Strategies in First-line in Patients With Epithelial Advanced Ovarian Cancer

• Status: Recruiting
• Trial end date: 2032-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

CHIMOVIP is a study to determine the best therapeutic strategy in patient with ovarian advanced cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Groupe Hospitalier Diaconesses Croix Saint-Simon
• Collaborator: GERCOR - Multidisciplinary Oncology Cooperative Group
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Cisplatin; Epirubicin; Paclitaxel

Criteria

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