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
- Diseases
- Ovarian cancer
- 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
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Georges François Leclerc Coordinator of this site? Confirm its status | Dijon | France | Recruiting |
| Institut Hospitalier Franco-Britannique Coordinator of this site? Confirm its status | Levallois-Perret | France | Recruiting |
| Hôpital Saint-Antoine Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Groupe Hospitalier Diaconesses Croix Saint-Simon Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Hôpital Poissy Saint Germain Coordinator of this site? Confirm its status | Poissy | France | Recruiting |
| CHU Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Recruiting |
| Centre Hospitalier Senlis Coordinator of this site? Confirm its status | Senlis | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.