A Phase 2 interventional study of CC0 - Carboplatin (IV) - Paclitaxel (IV) and CC0 - Cisplatin (IP) - Epirubicin (IV) in Ovarian Cancer, Epithelial, sponsored by Groupe Hospitalier Diaconesses Croix Saint-Simon. Recruiting at 7 sites in France. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-02-11.
Sponsored by Groupe Hospitalier Diaconesses Croix Saint-Simon · Phase 2, Interventional, and Treatment
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).
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's planned enrollment of 84 is above the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Groupe Hospitalier Diaconesses Croix Saint-Simon is the lead sponsor of 26 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Drug: CC0 - Carboplatin (IV) - Paclitaxel (IV) · Drug: CC>0 - Carboplatin (IV)- Paclitaxel (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.
Drug: CC0 - Cisplatin (IP) - Epirubicin (IV) · Drug: CC>0 - Cisplatin (IP/IV)- Epirubicin (IV)
(6 cycles)
(6 cycles)
* carboplatin (IV) - paclitaxel (IV) (3 cycles) * Interval surgery * Carboplatin (IV) - paclitaxel (IV) (3 cycles)
* 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)
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
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Groupe Hospitalier Diaconesses Croix Saint-Simon