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NCT Number: NCT03025477

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

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

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Key information

Conditions

Ovarian Cancer, Epithelial Adnexal Diseases Carcinoma Carcinoma, Ovarian Epithelial Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Centre Georges François Leclerc, Dijon, France

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Primary outcomes

  1. Pathological complete peritoneal response (pCR)

    Time frame: 2-year

    Interval debulking surgery or final evaluation peritoneal surgery

Secondary outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Delphine COCHEREAU, MD

CONTACT

Richard VILLET, MD

CONTACT

33 (0) 1 44 74 10 42

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Diaconesses Croix Saint-Simon

Other

Collaborators

  • GERCOR - Multidisciplinary Oncology Cooperative Group

Registry information

Official study 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

Acronym: CHIMOVIP

Important dates

Study start
2016
Primary completion
2021
Study completion
2032
First posted
Jan 19, 2017
Registry last updated
Feb 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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