Ovarian Cancer Clinical Trial
— OVHIPEC-2Official title:
Phase III Randomized Clinical Trial for Stage III Epithelial Ovarian Cancer Randomizing Between Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy
stage III epithelial ovarian cancer randomizing between primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy
| Status | Recruiting |
| Enrollment | 538 |
| Est. completion date | April 1, 2026 |
| Est. primary completion date | April 1, 2025 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Rigshospitalet Copenhagen | Copenhagen | |
| France | CHU de Besancon | Besançon | |
| France | Institut Bergonié | Bordeaux | |
| France | o Institut Bergonié, Bordeaux | Bordeaux | |
| France | CHU Lille | Lille | |
| France | Centre Leon Berard, Lyon | Lyon | |
| France | CHU Lyon | Lyon | |
| France | Institut du Cancer Montpellier | Montpellier | |
| France | Institut de Cancerologie de l'Ouest, ICO Nantes) | Nantes | |
| France | Institut Curie Paris | Paris | |
| France | CHRU Strasbourg | Strasbourg | |
| France | Oncopole, Institute Universitaire du Cancer de Toulouse (IUCT Toulouse) | Toulouse | |
| Ireland | Mater Misericordiae University Hospital, Dublin | Dublin | |
| Italy | Policlinico Sant'Orsola, Bologna | Bologna | |
| Italy | Fondazione Policlinico A Gemelli IRCCS | Roma | |
| Netherlands | Amsterdam UMC | Amsterdam | |
| Netherlands | Antoni van leeuwenhoek | Amsterdam | Noord-Holland |
| Netherlands | Catharina Hospital | Eindhoven | |
| Netherlands | Medisch Spectrum Twente | Enschede | |
| Netherlands | UMCG | Groningen | |
| Netherlands | Leiden University Medical Center (LUMC) | Leiden | |
| Netherlands | Maastricht UMC+ | Maastricht | |
| Netherlands | Radboud MC | Nijmegen | |
| Netherlands | Erasmus MC | Rotterdam | |
| Netherlands | UMCU | Utrecht | |
| Sweden | Alice Bjoernlund-Larsen | Uppsala | |
| United States | City of Hope | Duarte | California |
| United States | MSKCC New York | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| The Netherlands Cancer Institute |
United States, Denmark, France, Ireland, Italy, Netherlands, Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | overall survival | 1 year after last patient last visit | ||
| Secondary | recurrence-free survival | 1 year after last patient last visit | ||
| Secondary | adverse events | toxicity of extra treatment compared standaard treatment | 30 days after end of treatment | |
| Secondary | cost evaluation | cost evaluation based measured by quality adjusted life year | 1 year after lplv |
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