Trials / Active Not Recruiting
Active Not RecruitingNCT03772028
Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
Phase III Randomized Clinical Trial for Stage III Epithelial Ovarian Cancer Randomizing Between Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 538 (estimated)
- Sponsor
- The Netherlands Cancer Institute · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
stage III epithelial ovarian cancer randomizing between primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy
Detailed description
The objective of this study is to prove that treatment with primary cytoreductive surgery in combination with HIPEC (treatment arm) improves outcome compared to primary cytoreductive surgery without HIPEC (standard arm) with acceptable morbidity, in patients with FIGO stage III epithelial ovarian cancer who are eligible for primary cytoreductive surgery with no residual disease, or residual disease up to 2.5 mm.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | cisplatin | HIPEC with cisplatin after cytoreductive surgery |
Timeline
- Start date
- 2020-01-01
- Primary completion
- 2028-04-01
- Completion
- 2028-12-01
- First posted
- 2018-12-11
- Last updated
- 2026-04-08
Locations
28 sites across 7 countries: United States, Denmark, France, Ireland, Italy, Netherlands, Sweden
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03772028. Inclusion in this directory is not an endorsement.