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

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ClinicalTrials.gov Identifier: NCT03025477
Recruitment Status : Recruiting
First Posted : January 19, 2017
Last Update Posted : November 24, 2017
Sponsor:
Collaborator:
GERCOR - Multidisciplinary Oncology Cooperative Group
Information provided by (Responsible Party):
Groupe Hospitalier Diaconesses Croix Saint-Simon

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

Condition or disease Intervention/treatment Phase
Ovarian Cancer, Epithelial Drug: CC0 - Carboplatin (IV) - Paclitaxel (IV) Drug: CC0 - Cisplatin (IP) - Epirubicin (IV) Drug: CC>0 - Carboplatin (IV)- Paclitaxel (IV) Drug: CC>0 - Cisplatin (IP/IV)- Epirubicin (IV) Phase 2

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  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

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)




Primary Outcome Measures :
  1. Pathological complete peritoneal response (pCR) [ Time Frame: 2-year ]
    Interval debulking surgery or final evaluation peritoneal surgery


Secondary Outcome Measures :
  1. Quality of life (QLQ -C30) assessment [ Time Frame: Up to 2-year (at inclusion, after 3 cycles and end of treatment) ]
  2. Quality of life (QLQ-OV28) assessment [ Time Frame: Up to 2-year (at inclusion, after 3 cycles and end of treatment) ]
  3. IPSS score [ Time Frame: 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 [ Time Frame: 2-year ]
  5. Event-free survival (EFS) [ Time Frame: At 5-year and 10-year ]
  6. Objective response rate at the various surgical step [ Time Frame: Up to 2-year ]
  7. Overall survival (OS) [ Time Frame: At 5-year and 10-year ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03025477


Contacts
Contact: Richard VILLET, MD 33 (0) 1 44 74 10 42
Contact: Delphine COCHEREAU, MD

Locations
France
Centre Georges François Leclerc Recruiting
Dijon, France
Contact: Leïla BENGRINE, MD         
Principal Investigator: Leïla BENGRINE, MD         
Institut Hospitalier Franco-Britannique Recruiting
Levallois-Perret, France
Contact: Aimery De GRAMONT, MD         
Principal Investigator: Aimery De GRAMONT, MD         
Groupe Hospitalier Diaconesses Croix Saint Simon Recruiting
Paris, France
Contact: Richard VILLET, MD         
Principal Investigator: Richard VILLET, MD         
Hôpital Saint Antoine Recruiting
Paris, France
Contact: Honorine GERVAIS, MD         
Principal Investigator: Honorine GERVAIS, MD         
Sub-Investigator: Delphine COCHEREAU, MD         
Hôpital Poissy Saint Germain Recruiting
Poissy, France
Contact: Cyrille HUCHON, MD         
Principal Investigator: Cyrille HUCHON, MD         
CHU Poitiers Recruiting
Poitiers, France
Contact: Nadia RABAN         
Principal Investigator: Nadia RABAN, MD         
Centre Hospitalier Senlis Recruiting
Senlis, France
Contact: Elisabeth CAROLA, MD         
Principal Investigator: Elisabeth CAROLA, MD         
Sponsors and Collaborators
Groupe Hospitalier Diaconesses Croix Saint-Simon
GERCOR - Multidisciplinary Oncology Cooperative Group
Investigators
Principal Investigator: Richard VILLET, MD Groupe Hospitalier Diaconessess Croix Saint Simon

Responsible Party: Groupe Hospitalier Diaconesses Croix Saint-Simon
ClinicalTrials.gov Identifier: NCT03025477     History of Changes
Other Study ID Numbers: RVT_2015_2
First Posted: January 19, 2017    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: December 2016

Keywords provided by Groupe Hospitalier Diaconesses Croix Saint-Simon:
Intraperitoneal
Intravenous
Completeness of cytoreduction score
Carboplatin
Epirubicin
Paclitaxel
Cisplatin

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms by Histologic Type
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Carboplatin
Epirubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors