Informations générales (source: ClinicalTrials.gov)
Randomized Study Assessing Two Strategies of First Line: a Strategy With Intraperitoneal Chemotherapy and a Strategy With Total Intravenous Strategy, in Patients With Epithelial Advanced Ovarian Cancer (CHIMOVIP)
Interventional
Phase 2
Groupe Hospitalier Diaconesses Croix Saint-Simon (Voir sur ClinicalTrials)
octobre 2016
octobre 2032
29 juin 2024
CHIMOVIP is a study to determine the best therapeutic strategy in patient with ovarian
advanced cancer.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Saint Antoine | Romain COHEN, MD | Contact (sur clinicalTrials) | |||
| CHI POISSY ST-GERMAIN | Cyrille HUCHON, MD | Contact (sur clinicalTrials) | |||
| GRPE HOSP DIACONESSES-CROIX ST-SIMON | Richard VILLET, MD | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Georges François Leclerc - Dijon - France | Leïla BENGRINE, MD | Contact (sur clinicalTrials) | |||
| Centre Hospitalier Senlis - Senlis - France | Elisabeth CAROLA, MD | Contact (sur clinicalTrials) | |||
| CHU Poitiers - Poitiers - France | Nadia RABAN | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Institut Hospitalier Franco-Britannique - Levallois-Perret - France | Aimery De GRAMONT, MD | Contact (sur clinicalTrials) | |||
Critères
Femme
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.
- 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.
- 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