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

February 10, 2021 updated by: Groupe Hospitalier Diaconesses Croix Saint-Simon

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Richard VILLET, MD
  • Phone Number: 33 (0) 1 44 74 10 42

Study Contact Backup

  • Name: Delphine COCHEREAU, MD

Study Locations

  • France
      • Dijon, France
        • Recruiting
        • Centre Georges François Leclerc
      • Levallois-Perret, France
        • Recruiting
        • Institut hospitalier franco-britannique
        • Sub-Investigator:
          • Delphine COCHEREAU, MD
      • Paris, France
        • Recruiting
        • Hôpital Saint Antoine
      • Paris, France
        • Recruiting
        • Groupe Hospitalier Diaconesses Croix Saint Simon
        • Contact:
          • Richard VILLET, MD
        • Principal Investigator:
          • Richard VILLET, MD
      • Poissy, France
        • Recruiting
        • Hôpital Poissy Saint Germain
        • Contact:
          • Cyrille HUCHON, MD
        • Principal Investigator:
          • Cyrille HUCHON, MD
      • Poitiers, France
        • Recruiting
        • CHU Poitiers
        • Contact:
          • Nadia RABAN
      • Senlis, France
        • Recruiting
        • Centre Hospitalier Senlis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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:

  • Carboplatin AUC 6 - IV - Day (D) 1
  • Paclitaxel 80mg / m² - IV - D1, D8, D15

one cycle every 3 weeks
Drug: CC0 - Carboplatin (IV) - Paclitaxel (IV)
(6 cycles)
Drug: CC>0 - Carboplatin (IV)- Paclitaxel (IV)
  • carboplatin (IV) - paclitaxel (IV) (3 cycles)
  • Interval surgery
  • Carboplatin (IV) - paclitaxel (IV) (3 cycles)
EXPERIMENTAL: Experimental arm

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.
Drug: CC0 - Cisplatin (IP) - Epirubicin (IV)
(6 cycles)
Drug: CC>0 - Cisplatin (IP/IV)- Epirubicin (IV)
  • 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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pathological complete peritoneal response (pCR)
Time Frame: 2-year
Interval debulking surgery or final evaluation peritoneal surgery
2-year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Quality of life (QLQ -C30) assessment
Time Frame: Up to 2-year (at inclusion, after 3 cycles and end of treatment)
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)
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)
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
2-year
Event-free survival (EFS)
Time Frame: At 5-year and 10-year
At 5-year and 10-year
Objective response rate at the various surgical step
Time Frame: Up to 2-year
Up to 2-year
Overall survival (OS)
Time Frame: At 5-year and 10-year
At 5-year and 10-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Groupe Hospitalier Diaconesses Croix Saint-Simon

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
GERCOR - Multidisciplinary Oncology Cooperative Group

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Richard VILLET, MD, Groupe Hospitalier Diaconessess Croix Saint Simon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2016

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2021

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2017

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 19, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 11, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RVT_2015_2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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