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NCT03025477RecruitingPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 11 Feb 2021 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
84 (estimated)
First submitted
15 Dec 2016
Start date
1 Oct 2016
Primary completion date
31 Oct 2021
Lead sponsor
Groupe Hospitalier Diaconesses Croix Saint-Simon
NCT number
NCT03025477

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 84
  • From 1 Oct 2016 to the primary completion date, 31 Oct 2021
  • 7 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patient having received previous chemotherapy for ovarian cancer.
  • Concomitant administration of prophylactic phenytoin or live attenuated viral vaccines such as yellow fever vaccine,

Other illness

  • FIGO stage IV extra-abdominal disease, with the exception of lymph nodes and pleural invasion.
  • Other invasive cancer in the past 5 years (baso- and spinocellular cutaneous carcinoma with complete resection are accepted)
  • Patients with known hypersensitivity to any component of study drug

Lab values

  • Left ventricular ejection fraction \< 50% before chemotherapy initiation

Other

  • Patients without motivation or capacity to respect study requirements and constraints
  • Pregnancy or breast feeding women

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centre Georges François Leclerc
Coordinator of this site? Confirm its status
DijonFranceRecruiting
Institut Hospitalier Franco-Britannique
Coordinator of this site? Confirm its status
Levallois-PerretFranceRecruiting
Hôpital Saint-Antoine
Coordinator of this site? Confirm its status
ParisFranceRecruiting
Groupe Hospitalier Diaconesses Croix Saint-Simon
Coordinator of this site? Confirm its status
ParisFranceRecruiting
Hôpital Poissy Saint Germain
Coordinator of this site? Confirm its status
PoissyFranceRecruiting
CHU Poitiers
Coordinator of this site? Confirm its status
PoitiersFranceRecruiting
Centre Hospitalier Senlis
Coordinator of this site? Confirm its status
SenlisFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.