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

NCT ID: NCT03025477

Last Updated: 2021-02-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2032-10-31

Brief Summary

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

Detailed 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).

Conditions

Ovarian Cancer, Epithelial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control arm

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

Group Type: ACTIVE_COMPARATOR

CC0 - Carboplatin (IV) - Paclitaxel (IV)

Intervention Type: DRUG

(6 cycles)

CC>0 - Carboplatin (IV)- Paclitaxel (IV)

Intervention Type: DRUG

• carboplatin (IV) - paclitaxel (IV) (3 cycles)
• Interval surgery
• Carboplatin (IV) - paclitaxel (IV) (3 cycles)

Experimental arm

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.

Group Type: EXPERIMENTAL

CC0 - Cisplatin (IP) - Epirubicin (IV)

Intervention Type: DRUG

(6 cycles)

CC>0 - Cisplatin (IP/IV)- Epirubicin (IV)

Intervention Type: DRUG

• 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)

Interventions

CC0 - Carboplatin (IV) - Paclitaxel (IV)

(6 cycles)

Intervention Type: DRUG

CC0 - Cisplatin (IP) - Epirubicin (IV)

(6 cycles)

Intervention Type: DRUG

CC>0 - Carboplatin (IV)- Paclitaxel (IV)

• carboplatin (IV) - paclitaxel (IV) (3 cycles)
• Interval surgery
• Carboplatin (IV) - paclitaxel (IV) (3 cycles)

Intervention Type: DRUG

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)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

GERCOR - Multidisciplinary Oncology Cooperative Group

OTHER

Sponsor Role: collaborator

Groupe Hospitalier Diaconesses Croix Saint-Simon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard VILLET, MD

Role: PRINCIPAL_INVESTIGATOR

Groupe Hospitalier Diaconessess Croix Saint Simon

Locations

Centre Georges François Leclerc

Dijon, , France

Site Status: RECRUITING

Institut Hospitalier Franco-Britannique

Levallois-Perret, , France

Site Status: RECRUITING

Groupe Hospitalier Diaconesses Croix Saint Simon

Paris, , France

Site Status: RECRUITING

Hôpital Saint Antoine

Paris, , France

Site Status: RECRUITING

Hôpital Poissy Saint Germain

Poissy, , France

Site Status: RECRUITING

CHU Poitiers

Poitiers, , France

Site Status: RECRUITING

Centre Hospitalier Senlis

Senlis, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Richard VILLET, MD

Role: CONTACT

33 (0) 1 44 74 10 42

Delphine COCHEREAU, MD

Role: CONTACT

Facility Contacts

Leïla BENGRINE, MD

Role: primary

Aimery De GRAMONT, MD

Role: primary

Richard VILLET, MD

Role: primary

Romain COHEN, MD

Role: primary

Cyrille HUCHON, MD

Role: primary

Nadia RABAN

Role: primary

Elisabeth CAROLA, MD

Role: primary

Other Identifiers

RVT_2015_2

Identifier Type: -

Identifier Source: org_study_id