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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
Are there results?
Not yet: the study is under way

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

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).

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 groupRoleWhat they receive
Control armActive 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
Receives: Drug: CC0 - Carboplatin (IV) - Paclitaxel (IV); Drug: CC>0 - Carboplatin (IV)- Paclitaxel (IV)
Experimental armExperimentalInitial 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.

  1. Pathological complete peritoneal response (pCR)

    Interval debulking surgery or final evaluation peritoneal surgery

    Measured: 2-year

Secondary outcomes (7)

  1. Quality of life (QLQ -C30) assessment

    Measured: Up to 2-year (at inclusion, after 3 cycles and end of treatment)

  2. Quality of life (QLQ-OV28) assessment

    Measured: Up to 2-year (at inclusion, after 3 cycles and end of treatment)

  3. IPSS score

    Measured: Up to 2-year (at inclusion, after 3 cycles and end of treatment)

  4. Number of patients with treatment-related adverse events as assessed by CTCAE version 4.03

    Measured: 2-year

  5. Event-free survival (EFS)

    Measured: At 5-year and 10-year

  6. Objective response rate at the various surgical step

    Measured: Up to 2-year

  7. 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.

  1. First posted19 Jan 2017 (estimated)
  2. Study startOct 2016
  3. Primary completionOct 2021 (estimated)
  4. Study completionOct 2032 (estimated)

Resources

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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Richard VILLET, MD (33 (0) 1 44 74 10 42), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete peritoneal response (pCR) (time frame: 2-year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03025477.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.

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