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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

84

Phase

  • 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

  • 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

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
Intervention / Treatment
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

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

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

Groupe Hospitalier Diaconesses Croix Saint-Simon

Collaborators

GERCOR - Multidisciplinary Oncology Cooperative Group

Investigators

  • 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)

October 1, 2016

Primary Completion (ANTICIPATED)

October 1, 2021

Study Completion (ANTICIPATED)

October 1, 2032

Study Registration Dates

First Submitted

December 15, 2016

First Submitted That Met QC Criteria

January 16, 2017

First Posted (ESTIMATE)

January 19, 2017

Study Record Updates

Last Update Posted (ACTUAL)

February 11, 2021

Last Update Submitted That Met QC Criteria

February 10, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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