Surgery with or without heated chemotherapy for ovarian cancer
Phase III Randomized Clinical Trial for Stage III Epithelial Ovarian Cancer Randomizing Between Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy
This study is testing whether adding heated chemotherapy during surgery can help people with stage III ovarian cancer do better than surgery alone.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 538 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | The Netherlands Cancer Institute Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 28 sites (Duarte, California and 27 other locations) |
| Trial ID | NCT03772028 on ClinicalTrials.gov |
What this trial studies
This study aims to determine whether combining primary cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) improves outcomes for patients with stage III epithelial ovarian cancer compared to surgery alone. Patients eligible for the study will be randomized into two groups: one receiving the combination treatment and the other receiving only surgery. The study will assess the effectiveness and safety of the treatment approach, focusing on morbidity and overall survival rates. The goal is to establish a more effective treatment protocol for this patient population.
Who should consider this trial
Good fit: Ideal candidates are patients with FIGO stage III primary epithelial ovarian cancer who are eligible for primary cytoreductive surgery.
Not a fit: Patients with FIGO stage IV disease or those for whom complete primary cytoreduction is impossible will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve survival rates and quality of life for patients with advanced ovarian cancer.
How similar studies have performed: Previous studies have shown promising results with HIPEC in similar contexts, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * candidate for primary CRS * histological or cytological proven FIGO stage III primary epithelial ovarian, fallopian tube, or extra-ovarian cancer Exclusion Criteria: * history of previous malignancies within 5 years prior to inclusion * FIGO stage IV disease * complete primary cytoreduction is impossible * prior treatment for the current malignancy
Where this trial is running
Duarte, California and 27 other locations
- City of Hope — Duarte, California, United States (Recruiting)
- MSKCC New York — New York, New York, United States (Recruiting)
- Rigshospitalet Copenhagen — Copenhagen, Denmark (Recruiting)
- CHU de Besancon — Besançon, France (Recruiting)
- Institut Bergonié — Bordeaux, France (Recruiting)
- o Institut Bergonié, Bordeaux — Bordeaux, France (Recruiting)
- CHU Lille — Lille, France (Recruiting)
- Centre Leon Berard, Lyon — Lyon, France (Recruiting)
- CHU Lyon — Lyon, France (Recruiting)
- Institut du Cancer Montpellier — Montpellier, France (Recruiting)
- Institut de Cancerologie de l'Ouest, ICO Nantes) — Nantes, France (Recruiting)
- Institut Curie Paris — Paris, France (Recruiting)
- CHRU Strasbourg — Strasbourg, France (Recruiting)
- Oncopole, Institute Universitaire du Cancer de Toulouse (IUCT Toulouse) — Toulouse, France (Recruiting)
- Mater Misericordiae University Hospital, Dublin — Dublin, Ireland (Recruiting)
- Policlinico Sant'Orsola, Bologna — Bologna, Italy (Recruiting)
- Fondazione Policlinico A Gemelli IRCCS — Roma, Italy (Recruiting)
- Antoni van leeuwenhoek — Amsterdam, Noord-Holland, Netherlands (Recruiting)
- Amsterdam UMC — Amsterdam, Netherlands (Recruiting)
- Catharina Hospital — Eindhoven, Netherlands (Recruiting)
- Medisch Spectrum Twente — Enschede, Netherlands (Recruiting)
- Umcg — Groningen, Netherlands (Recruiting)
- Leiden University Medical Center (LUMC) — Leiden, Netherlands (Recruiting)
- Maastricht UMC+ — Maastricht, Netherlands (Recruiting)
- Radboud MC — Nijmegen, Netherlands (Recruiting)
- Erasmus MC — Rotterdam, Netherlands (Recruiting)
- Umcu — Utrecht, Netherlands (Recruiting)
- Alice Bjoernlund-Larsen — Uppsala, Sweden (Recruiting)
Study contacts
- Study coordinator: Willemien van Driel, MD, PhD
- Email: OVHIPEC@nki.nl
- Phone: 031 20 512 7918
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.