Feasibility of a chemotherapy with the two agents Carboplatin and Paclitaxel, that is applied heated directly into the abdomen after surgery of patients with advanced cancer of the ovary

Feasibility of intraoperative hyperthermic intraperitoneal chemotherapy with carboplatin and paclitaxel in patients with advanced epithelial ovarian cancer – a combined phase I / II trial - HIPEC-Ovar

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003244-76-AT

Enrollment

Registered

2014-06-03

Start date

2014-07-11

Completion date

Unknown

Last updated

2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otherwise treatment-naive patients with epithelial ovarian cancer, FIGO III - IVa

Interventions

Trade Name: Carboplatin Actavis 10 mg/ml concentrate Pharmaceutical Form: Concentrate and solvent for solution for infusion Trade Name: Paclitaxel Hospira 6 mg/ml concentrate Pharmaceutical Form: Con

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age >=18 years and =65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: Age 75 years, other histology than epithelial ovarian cancer or epithelial ovarian cancer with FIGO other than III - IVa, visible tumor rest at the end of surgery >=0,5cm, no signed informed consent, medical circumstances that prohibit the performance of a HIPEC

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate feasibility and rate of morbidity of a hyperthermic intraperitoneal chemotherapy with carboplatin and paclitaxel in patients with advanced epithelial ovarian cancer, who did not receive previous treatment and in whom cytoreduction with visible tumor rest at the end of operation <0,5cm.;Secondary Objective: To find the maximal tolerable dose of paclitaxel in the combination with carboplatin as HIPEC. Assessment of pharmacokinetic measurements. Measurement of the effects of HIPEC on tumor tissue and ascites cells (in vitro) and the association to specific genes and small RNAs on these effects. To evaluate the effect on disease-free and overall survival after three and five years. To evaluate the effect on life time quality.;Primary end point(s): Rate of morbidity within 30 days after surgery and HIPEC;Timepoint(s) of evaluation of this end point: 30 days after HIPEC	—

Measure

Time frame

Main Objective: To evaluate feasibility and rate of morbidity of a hyperthermic intraperitoneal chemotherapy with carboplatin and paclitaxel in patients with advanced epithelial ovarian cancer, who did not receive previous treatment and in whom cytoreduction with visible tumor rest at the end of operation <0,5cm.;Secondary Objective: To find the maximal tolerable dose of paclitaxel in the combination with carboplatin as HIPEC. Assessment of pharmacokinetic measurements. Measurement of the effects of HIPEC on tumor tissue and ascites cells (in vitro) and the association to specific genes and small RNAs on these effects. To evaluate the effect on disease-free and overall survival after three and five years. To evaluate the effect on life time quality.;Primary end point(s): Rate of morbidity within 30 days after surgery and HIPEC;Timepoint(s) of evaluation of this end point: 30 days after HIPEC

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Secondary

Measure	Time frame
Secondary end point(s): maximal tolerable dose of paclitaxel in combination with carboplatin as HIPEC; effect on disease-free and overall survival after three and five years; effect on life time quality effects on tumor tissue and cells (in vitro) and the association to specific genes and small RNAs;Timepoint(s) of evaluation of this end point: maximal tolerable dose of paclitaxel: 30 days after HIPEC effect on survival: three and five years after treatment; effect on life time quality: before, one week after HIPEC, at the end of treatment and one year after treatment effect on tumor tissue: end of study	—

Measure

Time frame

Secondary end point(s): maximal tolerable dose of paclitaxel in combination with carboplatin as HIPEC; effect on disease-free and overall survival after three and five years; effect on life time quality effects on tumor tissue and cells (in vitro) and the association to specific genes and small RNAs;Timepoint(s) of evaluation of this end point: maximal tolerable dose of paclitaxel: 30 days after HIPEC effect on survival: three and five years after treatment; effect on life time quality: before, one week after HIPEC, at the end of treatment and one year after treatment effect on tumor tissue: end of study

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Countries

Austria

Contacts

Public ContactDepartment of Gynecology

Medical University of Vienna

veronika.seebacher@meduniwien.ac.at00431404002915

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Apr 23, 2026