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Recruiting NCT03025477

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

Phase II Interventional Ovarian Cancer, Epithelial

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CC0 - Carboplatin (IV) - Paclitaxel (IV), CC0 - Cisplatin (IP) - Epirubicin (IV), CC>0 - Carboplatin (IV)- Paclitaxel (IV), CC>0 - Cisplatin (IP/IV)- Epirubicin (IV).
Who it may be relevant to
Registry conditions: Ovarian Cancer, Epithelial. Basic parameters: 18 years — 75 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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).

Interventions

  • Drug CC0 - Carboplatin (IV) - Paclitaxel (IV)
    (6 cycles)
  • Drug CC0 - Cisplatin (IP) - Epirubicin (IV)
    (6 cycles)
  • Drug CC>0 - Carboplatin (IV)- Paclitaxel (IV)
    * carboplatin (IV) - paclitaxel (IV) (3 cycles) * Interval surgery * Carboplatin (IV) - paclitaxel (IV) (3 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

  • Pathological complete peritoneal response (pCR) [Time frame: 2-year]
Secondary outcome measures (7)
  • Quality of life (QLQ -C30) assessment [Time frame: 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)]
  • IPSS score [Time frame: 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]
  • Event-free survival (EFS) [Time frame: At 5-year and 10-year]
  • Objective response rate at the various surgical step [Time frame: Up to 2-year]
  • Overall survival (OS) [Time frame: At 5-year and 10-year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

France · 7 centers
  • Centre Georges François Leclerc — Dijon
  • Institut Hospitalier Franco-Britannique — Levallois-Perret
  • Groupe Hospitalier Diaconesses Croix Saint Simon — Paris
  • Hôpital Saint Antoine — Paris
  • Hôpital Poissy Saint Germain — Poissy
  • CHU Poitiers — Poitiers
  • Centre Hospitalier Senlis — Senlis

Identifiers

NCT: NCT03025477 · RVT_2015_2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗