Comparing two treatment methods for 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
This study is testing which chemotherapy method works better for people with advanced ovarian cancer after surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Groupe Hospitalier Diaconesses Croix Saint-Simon Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 7 sites (Dijon and 6 other locations) |
| Trial ID | NCT03025477 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with histologically confirmed advanced epithelial ovarian cancer who have undergone recent debulking or diagnostic surgery.
Not a fit: Patients with FIGO stage IV extra-abdominal disease or those who have previously received chemotherapy for ovarian cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with advanced ovarian cancer, potentially enhancing survival rates and quality of life.
How similar studies have performed: Other studies have explored similar therapeutic strategies in ovarian cancer, showing promising results, but this specific approach is being evaluated in a novel context.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Dijon and 6 other locations
- 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)
- Centre Hospitalier Senlis — Senlis, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.