Two Therapeutic Strategies in First-line in Patients With Epithelial Advanced Ovarian Cancer
CHIMOVIP
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
1 other identifier
interventional
84
1 country
7
Brief Summary
CHIMOVIP is a study to determine the best therapeutic strategy in patient with ovarian advanced cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2016
Longer than P75 for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
December 15, 2016
CompletedFirst Posted
Study publicly available on registry
January 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2032
ExpectedFebruary 11, 2021
February 1, 2021
5 years
December 15, 2016
February 10, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pathological complete peritoneal response (pCR)
Interval debulking surgery or final evaluation peritoneal surgery
2-year
Secondary Outcomes (7)
Quality of life (QLQ -C30) assessment
Up to 2-year (at inclusion, after 3 cycles and end of treatment)
Quality of life (QLQ-OV28) assessment
Up to 2-year (at inclusion, after 3 cycles and end of treatment)
IPSS score
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
2-year
Event-free survival (EFS)
At 5-year and 10-year
- +2 more secondary outcomes
Study Arms (2)
Control arm
ACTIVE COMPARATORInitial 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
Experimental arm
EXPERIMENTALInitial 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.
Interventions
* 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)
Eligibility Criteria
You may qualify if:
- 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.
- 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).
- Creatinine clearance MDRD ≥ 60 mL/min
- Registration in a national health care system (CMU included).
- Signed and dated informed consent.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
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, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard VILLET, MD
Groupe Hospitalier Diaconessess Croix Saint Simon
Central Study Contacts
Delphine COCHEREAU, MD
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2016
First Posted
January 19, 2017
Study Start
October 1, 2016
Primary Completion
October 1, 2021
Study Completion (Estimated)
October 1, 2032
Last Updated
February 11, 2021
Record last verified: 2021-02