CHIMOVIP is a study to determine the best therapeutic strategy in patient with ovarian advanced cancer.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
84
(6 cycles)
(6 cycles)
* carboplatin (IV) - paclitaxel (IV) (3 cycles) * Interval surgery * Carboplatin (IV) - paclitaxel (IV) (3 cycles)
Centre Georges François Leclerc
Dijon, France
RECRUITINGInstitut Hospitalier Franco-Britannique
Levallois-Perret, France
RECRUITINGGroupe Hospitalier Diaconesses Croix Saint Simon
Paris, France
Pathological complete peritoneal response (pCR)
Interval debulking surgery or final evaluation peritoneal surgery
Time frame: 2-year
Quality of life (QLQ -C30) assessment
Time frame: Up to 2-year (at inclusion, after 3 cycles and end of treatment)
Quality of life (QLQ-OV28) assessment
Time frame: Up to 2-year (at inclusion, after 3 cycles and end of treatment)
IPSS score
Time frame: 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
Time frame: 2-year
Event-free survival (EFS)
Time frame: At 5-year and 10-year
Objective response rate at the various surgical step
Time frame: Up to 2-year
Overall survival (OS)
Time frame: At 5-year and 10-year
Delphine COCHEREAU, MD
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
* 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)
Hôpital Saint Antoine
Paris, France
RECRUITINGHôpital Poissy Saint Germain
Poissy, France
RECRUITINGCHU Poitiers
Poitiers, France
RECRUITINGCentre Hospitalier Senlis
Senlis, France
RECRUITING