Ovarian Cancer, EpithelialPhase 2CHIMOVIPNCT03025477

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

A Phase 2 study testing CC0 - Carboplatin (IV) - Paclitaxel (IV), CC0 - Cisplatin (IP) - Epirubicin (IV) and CC>0 - Carboplatin (IV)- Paclitaxel (IV) in people with Ovarian Cancer, Epithelial, run by Groupe Hospitalier Diaconesses Croix Saint-Simon at 7 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

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

Who is it for?: Ages 18 to 75 years, women only
Conditions the study is for: Ovarian Cancer, Epithelial
What is being tested?: CC0 - Carboplatin (IV) - Paclitaxel (IV), CC0 - Cisplatin (IP) - Epirubicin (IV) and CC>0 - Carboplatin (IV)- Paclitaxel (IV)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 84 participants
Where: 7 sitesFrance
Study dates: Oct 2016to Oct 2032
Phase: Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Richard VILLET, MD contact

33 (0) 1 44 74 10 42

Delphine COCHEREAU, MD contact

City, postcode or hospital

Sites recruiting now only

7 sites in 1 country

France7 sites, 7 recruiting

Centre Georges François Leclerc
Dijon
Leïla BENGRINE, MD
Leïla BENGRINE, MD
Recruiting
Institut Hospitalier Franco-Britannique
Levallois-Perret
Aimery De GRAMONT, MD
Aimery De GRAMONT, MD
Recruiting
Groupe Hospitalier Diaconesses Croix Saint Simon
Paris
Richard VILLET, MD
Richard VILLET, MD
Recruiting
Hôpital Saint Antoine
Paris
Romain COHEN, MD
Romain COHEN, MD
Recruiting
Hôpital Poissy Saint Germain
Poissy
Cyrille HUCHON, MD
Cyrille HUCHON, MD
Recruiting
CHU Poitiers
Poitiers
Nadia RABAN
Nadia RABAN, MD
Recruiting
Centre Hospitalier Senlis
Senlis
Elisabeth CAROLA, MD
Elisabeth CAROLA, MD
Recruiting

Other trials in France

About this study

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

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

Read the 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
Being tested: CC0 - Carboplatin (IV) - Paclitaxel (IV), CC0 - Cisplatin (IP) - Epirubicin (IV), CC>0 - Carboplatin (IV)- Paclitaxel (IV), CC>0 - Cisplatin (IP/IV)- Epirubicin (IV)
Keywords: Intraperitoneal, Intravenous, Completeness of cytoreduction score, Carboplatin, Epirubicin, Paclitaxel, Cisplatin
Medical subject headings: Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CC0 - Carboplatin (IV) - Paclitaxel (IV)Drug
(6 cycles)
CC0 - Cisplatin (IP) - Epirubicin (IV)Drug
(6 cycles)
CC>0 - Carboplatin (IV)- Paclitaxel (IV)Drug
- carboplatin (IV) - paclitaxel (IV) (3 cycles)
- Interval surgery
- Carboplatin (IV) - paclitaxel (IV) (3 cycles)
CC>0 - Cisplatin (IP/IV)- Epirubicin (IV)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)

Study groups in NCT03025477
Study group	Role	What they receive
Control arm	Active comparator	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 Receives: Drug: CC0 - Carboplatin (IV) - Paclitaxel (IV); Drug: CC>0 - Carboplatin (IV)- Paclitaxel (IV)
Experimental arm	Experimental	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. Receives: Drug: CC0 - Cisplatin (IP) - Epirubicin (IV); Drug: CC>0 - Cisplatin (IP/IV)- Epirubicin (IV)

What is being measured

The primary outcome is the main question the study is designed to answer.

Pathological complete peritoneal response (pCR)
Interval debulking surgery or final evaluation peritoneal surgery
Measured: 2-year

Secondary outcomes (7)

Quality of life (QLQ -C30) assessment
Measured: Up to 2-year (at inclusion, after 3 cycles and end of treatment)
Quality of life (QLQ-OV28) assessment
Measured: Up to 2-year (at inclusion, after 3 cycles and end of treatment)
IPSS score
Measured: 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
Measured: 2-year
Event-free survival (EFS)
Measured: At 5-year and 10-year
Objective response rate at the various surgical step
Measured: Up to 2-year
Overall survival (OS)
Measured: At 5-year and 10-year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2016Oct 2032

First posted19 Jan 2017 (estimated)
Study startOct 2016
Primary completionOct 2021 (estimated)
Study completionOct 2032 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Ovarian Cancer, EpithelialStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 84 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03025477
Sponsor's protocol ID: RVT_2015_2
Acronym: CHIMOVIP
Status last verified: Feb 2021
First submitted: 15 Dec 2016
Last updated: 11 Feb 2021
Results posted: No
Data monitoring committee: Yes

Interested in taking part?

Richard VILLET, MD

33 (0) 1 44 74 10 42

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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A Study to Assess Anti-Tumor Activity of Intravenously (IV) Infused Carboplatin With Mirvetuximab Soravtansine in Participants With Newly Diagnosed Folate Receptor Alpha (FRα)Expressing Advanced-Stage Serous Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer.
Epithelial Ovarian Cancer, Fallopian Tube Cancer
Recruiting
OV Precision: Study Examining the Benefit of a Tumor- and Patient-specific Cancer Therapy
Ovarian Neoplasm Epithelial, Fallopian Tube Neoplasms
Recruiting
A Blended e-Health Intervention to Improve Fear of Progression in Women With Gynecologic or Breast Cancer
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8

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