Two Therapeutic Strategies in First-line in Patients With Epithelial Advanced Ovarian Cancer (CHIMOVIP)
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|ClinicalTrials.gov Identifier: NCT03025477|
Recruitment Status : Recruiting
First Posted : January 19, 2017
Last Update Posted : February 11, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Ovarian Cancer, Epithelial||Drug: CC0 - Carboplatin (IV) - Paclitaxel (IV) Drug: CC0 - Cisplatin (IP) - Epirubicin (IV) Drug: CC>0 - Carboplatin (IV)- Paclitaxel (IV) Drug: CC>0 - Cisplatin (IP/IV)- Epirubicin (IV)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||October 2016|
|Estimated Primary Completion Date :||October 2021|
|Estimated Study Completion Date :||October 2032|
Active Comparator: 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:
one cycle every 3 weeks
Drug: CC0 - Carboplatin (IV) - Paclitaxel (IV)
Drug: CC>0 - Carboplatin (IV)- Paclitaxel (IV)
Experimental: Experimental arm
Initial or interval surgery associated with 6 cycles of chemotherapy of cisplatin and epirubicin.
The regimen of administration of the chemotherapy is as following:
one Cycle every 3 weeks.
Drug: CC0 - Cisplatin (IP) - Epirubicin (IV)
Drug: CC>0 - Cisplatin (IP/IV)- Epirubicin (IV)
- Pathological complete peritoneal response (pCR) [ Time Frame: 2-year ]Interval debulking surgery or final evaluation peritoneal surgery
- 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 ]
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|Ages Eligible for Study:||18 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03025477
|Contact: Richard VILLET, MD||33 (0) 1 44 74 10 42|
|Contact: Delphine COCHEREAU, MD|
|Centre Georges François Leclerc||Recruiting|
|Contact: Leïla BENGRINE, MD|
|Principal Investigator: Leïla BENGRINE, MD|
|Institut Hospitalier Franco-Britannique||Recruiting|
|Contact: Aimery De GRAMONT, MD|
|Principal Investigator: Aimery De GRAMONT, MD|
|Sub-Investigator: Delphine COCHEREAU, MD|
|Groupe Hospitalier Diaconesses Croix Saint Simon||Recruiting|
|Contact: Richard VILLET, MD|
|Principal Investigator: Richard VILLET, MD|
|Hôpital Saint Antoine||Recruiting|
|Contact: Romain COHEN, MD|
|Principal Investigator: Romain COHEN, MD|
|Hôpital Poissy Saint Germain||Recruiting|
|Contact: Cyrille HUCHON, MD|
|Principal Investigator: Cyrille HUCHON, MD|
|Contact: Nadia RABAN|
|Principal Investigator: Nadia RABAN, MD|
|Centre Hospitalier Senlis||Recruiting|
|Contact: Elisabeth CAROLA, MD|
|Principal Investigator: Elisabeth CAROLA, MD|
|Principal Investigator:||Richard VILLET, MD||Groupe Hospitalier Diaconessess Croix Saint Simon|
|Responsible Party:||Groupe Hospitalier Diaconesses Croix Saint-Simon|
|Other Study ID Numbers:||
|First Posted:||January 19, 2017 Key Record Dates|
|Last Update Posted:||February 11, 2021|
|Last Verified:||February 2021|
Completeness of cytoreduction score
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Genital Neoplasms, Female
Endocrine System Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents, Phytogenic
Molecular Mechanisms of Pharmacological Action