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

Primary Purpose

Ovarian Cancer, Epithelial

Status
Recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
CC0 - Carboplatin (IV) - Paclitaxel (IV)
CC0 - Cisplatin (IP) - Epirubicin (IV)
CC>0 - Carboplatin (IV)- Paclitaxel (IV)
CC>0 - Cisplatin (IP/IV)- Epirubicin (IV)
Sponsored by
Groupe Hospitalier Diaconesses Croix Saint-Simon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer, Epithelial focused on measuring Intraperitoneal, Intravenous, Completeness of cytoreduction score, Carboplatin, Epirubicin, Paclitaxel, Cisplatin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Georges François LeclercRecruiting
  • Institut Hospitalier Franco-BritanniqueRecruiting
  • Groupe Hospitalier Diaconesses Croix Saint SimonRecruiting
  • Hôpital Saint AntoineRecruiting
  • Hôpital Poissy Saint GermainRecruiting
  • CHU PoitiersRecruiting
  • Centre Hospitalier SenlisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control arm

Experimental arm

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Pathological complete peritoneal response (pCR)
Interval debulking surgery or final evaluation peritoneal surgery

Secondary Outcome Measures

Quality of life (QLQ -C30) assessment
Quality of life (QLQ-OV28) assessment
IPSS score
Number of patients with treatment-related adverse events as assessed by CTCAE version 4.03
Event-free survival (EFS)
Objective response rate at the various surgical step
Overall survival (OS)

Full Information

First Posted
December 15, 2016
Last Updated
February 10, 2021
Sponsor
Groupe Hospitalier Diaconesses Croix Saint-Simon
Collaborators
GERCOR - Multidisciplinary Oncology Cooperative Group
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1. Study Identification

Unique Protocol Identification Number
NCT03025477
Brief Title
Two Therapeutic Strategies in First-line in Patients With Epithelial Advanced Ovarian Cancer
Acronym
CHIMOVIP
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 2016 (Actual)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
October 2032 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Groupe Hospitalier Diaconesses Croix Saint-Simon
Collaborators
GERCOR - Multidisciplinary Oncology Cooperative Group

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Epithelial
Keywords
Intraperitoneal, Intravenous, Completeness of cytoreduction score, Carboplatin, Epirubicin, Paclitaxel, Cisplatin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control arm
Arm Type
Active Comparator
Arm Description
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
Arm Title
Experimental arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
CC0 - Carboplatin (IV) - Paclitaxel (IV)
Intervention Description
(6 cycles)
Intervention Type
Drug
Intervention Name(s)
CC0 - Cisplatin (IP) - Epirubicin (IV)
Intervention Description
(6 cycles)
Intervention Type
Drug
Intervention Name(s)
CC>0 - Carboplatin (IV)- Paclitaxel (IV)
Intervention Description
carboplatin (IV) - paclitaxel (IV) (3 cycles) Interval surgery Carboplatin (IV) - paclitaxel (IV) (3 cycles)
Intervention Type
Drug
Intervention Name(s)
CC>0 - Cisplatin (IP/IV)- Epirubicin (IV)
Intervention Description
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)
Primary Outcome Measure Information:
Title
Pathological complete peritoneal response (pCR)
Description
Interval debulking surgery or final evaluation peritoneal surgery
Time Frame
2-year
Secondary Outcome Measure Information:
Title
Quality of life (QLQ -C30) assessment
Time Frame
Up to 2-year (at inclusion, after 3 cycles and end of treatment)
Title
Quality of life (QLQ-OV28) assessment
Time Frame
Up to 2-year (at inclusion, after 3 cycles and end of treatment)
Title
IPSS score
Time Frame
Up to 2-year (at inclusion, after 3 cycles and end of treatment)
Title
Number of patients with treatment-related adverse events as assessed by CTCAE version 4.03
Time Frame
2-year
Title
Event-free survival (EFS)
Time Frame
At 5-year and 10-year
Title
Objective response rate at the various surgical step
Time Frame
Up to 2-year
Title
Overall survival (OS)
Time Frame
At 5-year and 10-year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Richard VILLET, MD
Phone
33 (0) 1 44 74 10 42
First Name & Middle Initial & Last Name or Official Title & Degree
Delphine COCHEREAU, MD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard VILLET, MD
Organizational Affiliation
Groupe Hospitalier Diaconessess Croix Saint Simon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Georges François Leclerc
City
Dijon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leïla BENGRINE, MD
First Name & Middle Initial & Last Name & Degree
Leïla BENGRINE, MD
Facility Name
Institut Hospitalier Franco-Britannique
City
Levallois-Perret
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aimery De GRAMONT, MD
First Name & Middle Initial & Last Name & Degree
Aimery De GRAMONT, MD
First Name & Middle Initial & Last Name & Degree
Delphine COCHEREAU, MD
Facility Name
Groupe Hospitalier Diaconesses Croix Saint Simon
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard VILLET, MD
First Name & Middle Initial & Last Name & Degree
Richard VILLET, MD
Facility Name
Hôpital Saint Antoine
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Romain COHEN, MD
First Name & Middle Initial & Last Name & Degree
Romain COHEN, MD
Facility Name
Hôpital Poissy Saint Germain
City
Poissy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cyrille HUCHON, MD
First Name & Middle Initial & Last Name & Degree
Cyrille HUCHON, MD
Facility Name
CHU Poitiers
City
Poitiers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nadia RABAN
First Name & Middle Initial & Last Name & Degree
Nadia RABAN, MD
Facility Name
Centre Hospitalier Senlis
City
Senlis
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisabeth CAROLA, MD
First Name & Middle Initial & Last Name & Degree
Elisabeth CAROLA, MD

12. IPD Sharing Statement

Learn more about this trial

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

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