Clinical trial · Interventional
Intraperitoneal Aerosol High-pressure Chemotherapy for Women With Recurrent Ovarian Cancer
Feasibility, Efficacy and Safety of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) With Cisplatin and Doxorubicin in Women With Recurrent Ovarian Cancer: an Open-label, Single-arm Phase II Clinical Trial
NCT01809379CI-TRIAL-00059560completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This trial aims to assess efficacy and safety of an intraperitoneal, aerosol, high-pressure chemotherapy in women with recurrent ovarian cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemotherapy with doxorubicin and cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- intraperitoneal chemotherapy
- description
- Intraperitoneal chemotherapy with cisplatin at a dose of 7.5 mg/m2 body surface in a 150 ml NaCl 0.9% and doxorubicin at a dose of 1.5 mg/m2 body surface in a 50 ml NaCl 0.9% solution with a flow of 30 ml/min and a max upstream pressure of 200 psi.
- interventionNames
- Drug: chemotherapy with doxorubicin and cisplatin
Primary outcomes (1)
- measure
- Clinical Benefit Rate
- timeFrame
- 6 months
- description
- The clinical benefit rate comprises complete remission, partial remission, and stable disease according to RECIST criteria.
Secondary outcomes (1)
- measure
- safety
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * at least 2 lines of previous chemotherapy * recurrent ovarian cancer * patient is mobile * informed consent Exclusion Criteria: * ileus * necessity of parenteral nutrition
References
Publications (1)
- RESULTTempfer CB, Winnekendonk G, Solass W, Horvat R, Giger-Pabst U, Zieren J, Rezniczek GA, Reymond MA. Pressurized intraperitoneal aerosol chemotherapy in women with recurrent ovarian cancer: A phase 2 study. Gynecol Oncol. 2015 May;137(2):223-8. doi: 10.1016/j.ygyno.2015.02.009. Epub 2015 Feb 18. PMID 25701703