Clinical trial NCT03025477: Two Therapeutic Strategies in First-line in Patients With Epithelial Advanced Ovarian Cancer
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Ovarian Cancer, Epithelial
Keywords: Intraperitoneal
Intravenous
Completeness of cytoreduction score
Carboplatin
Epirubicin
Paclitaxel
Cisplatin
Lead sponsor: Groupe Hospitalier Diaconesses Croix Saint-Simon
Sponsor class: OTHER
Collaborators: name: GERCOR - Multidisciplinary Oncology Cooperative Group
First posted: 2017-01-19
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Pathological complete peritoneal response (pCR)
timeFrame: 2-year
Secondary outcomes:
measure: Quality of life (QLQ -C30) assessment
timeFrame: Up to 2-year (at inclusion, after 3 cycles and end of treatment)
measure: Quality of life (QLQ-OV28) assessment
timeFrame: Up to 2-year (at inclusion, after 3 cycles and end of treatment)
measure: IPSS score
timeFrame: Up to 2-year (at inclusion, after 3 cycles and end of treatment)
measure: Number of patients with treatment-related adverse events as assessed by CTCAE version 4.03
timeFrame: 2-year
measure: Event-free survival (EFS)
timeFrame: At 5-year and 10-year
measure: Objective response rate at the various surgical step
timeFrame: Up to 2-year
measure: Overall survival (OS)
timeFrame: At 5-year and 10-year
Other outcomes:
Locations:
city: Dijon
country: France
facility: Centre Georges François Leclerc
city: Levallois-Perret
country: France
facility: Institut Hospitalier Franco-Britannique
city: Paris
country: France
facility: Groupe Hospitalier Diaconesses Croix Saint Simon
city: Paris
country: France
facility: Hôpital Saint Antoine
city: Poissy
country: France
facility: Hôpital Poissy Saint Germain
city: Poitiers
country: France
facility: CHU Poitiers
city: Senlis
country: France
facility: Centre Hospitalier Senlis
Study officials:
affiliation: Groupe Hospitalier Diaconessess Croix Saint Simon
name: Richard VILLET, MD
role: PRINCIPAL_INVESTIGATOR
References: