Comparing two treatment methods for advanced ovarian cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized phase II clinical trial designed to evaluate the effectiveness of two different therapeutic strategies in patients with advanced epithelial ovarian cancer. Participants will undergo an initial surgical intervention and then be randomized based on their Completeness of Cytoreduction (CC) score to receive either intravenous or intraperitoneal chemotherapy regimens. The study aims to determine which treatment approach yields better outcomes for patients following surgery. It is multicentric and open-label, involving multiple healthcare institutions.

Why it matters

Who can join: the full rules

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

Where it's running

• Centre Georges François Leclerc
  Dijon, France Recruiting
• Institut Hospitalier Franco-Britannique
  Levallois-Perret, France Recruiting
• Groupe Hospitalier Diaconesses Croix Saint Simon
  Paris, France Recruiting
• Hôpital Saint Antoine
  Paris, France Recruiting
• Hôpital Poissy Saint Germain
  Poissy, France Recruiting
• CHU Poitiers
  Poitiers, France Recruiting

Study contacts

• Principal investigator: Richard VILLET, MD — Groupe Hospitalier Diaconessess Croix Saint Simon
• Study coordinator: Richard VILLET, MD
• Phone: 33 (0) 1 44 74 10 42

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.