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

Ovarian Cancer, Epithelial Clinical Trial

— CHIMOVIP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03025477
• Other study ID #: RVT_2015_2
• Status: Recruiting
• Phase: Phase 2
• Start date: October 2016
• Est. completion date: October 2032

Study information

• Verified date: February 2021
• Source: Groupe Hospitalier Diaconesses Croix Saint-Simon
• Contact: Richard VILLET, MD
• Phone: 33 (0) 1 44 74 10 42
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: October 2032
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer, Epithelial
• Ovarian Neoplasms

Intervention

Drug:
• 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)

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Groupe Hospitalier Diaconesses Croix Saint-Simon	GERCOR - Multidisciplinary Oncology Cooperative Group

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological complete peritoneal response (pCR)	Interval debulking surgery or final evaluation peritoneal surgery	2-year
Secondary	Quality of life (QLQ -C30) assessment		Up to 2-year (at inclusion, after 3 cycles and end of treatment)
Secondary	Quality of life (QLQ-OV28) assessment		Up to 2-year (at inclusion, after 3 cycles and end of treatment)
Secondary	IPSS score		Up to 2-year (at inclusion, after 3 cycles and end of treatment)
Secondary	Number of patients with treatment-related adverse events as assessed by CTCAE version 4.03		2-year
Secondary	Event-free survival (EFS)		At 5-year and 10-year
Secondary	Objective response rate at the various surgical step		Up to 2-year
Secondary	Overall survival (OS)		At 5-year and 10-year