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Clinical Trials in France / NCT03025477
Recruiting Phase 2

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

NCT03025477 · tracked via the Priya Life Science France tracker
Phase
Phase 2
Started
2016-10
Last updated
2021-02-11

Condition(s) studied

Ovarian Cancer, Epithelial

Investigational drug(s) / intervention(s)

CC0 - Carboplatin (IV) - Paclitaxel (IV)CC0 - Cisplatin (IP) - Epirubicin (IV)CC>0 - Carboplatin (IV)- Paclitaxel (IV)CC>0 - Cisplatin (IP/IV)- Epirubicin (IV)

CC0 - Carboplatin (IV) - Paclitaxel (IV): (6 cycles)

CC0 - Cisplatin (IP) - Epirubicin (IV): (6 cycles)

CC>0 - Carboplatin (IV)- Paclitaxel (IV): * carboplatin (IV) - paclitaxel (IV) (3 cycles) * Interval surgery * Carboplatin (IV) - paclitaxel (IV) (3 cycles)

CC>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)

Study summary

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

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
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

Primary outcome measure(s)

Trial sites (7)

FacilityCityRegionStatus
Centre Georges François Leclerc Dijon France Recruiting
Institut Hospitalier Franco-Britannique Levallois-Perret France Recruiting
Groupe Hospitalier Diaconesses Croix Saint Simon Paris France Recruiting
Hôpital Saint Antoine Paris France Recruiting
Hôpital Poissy Saint Germain Poissy France Recruiting
CHU Poitiers Poitiers France Recruiting
Centre Hospitalier Senlis Senlis France Recruiting

More Groupe Hospitalier Diaconesses Croix Saint-Simon trials in France

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03025477 on ClinicalTrials.gov ↗ ← All trials in France