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
- Conditions
- Otherwise treatment-naive patients with epithelial ovarian cancer, FIGO III - IVaTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-003244-76-AT
- Lead Sponsor
- Medical University of Vienna
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 20
Age >=18 years and <=75 years, epithelial ovarian cancer FIGO III - IVa, visible tumor rest at the end of surgery <0,5cm, signed informed consent, no medical circumstances that prohibit the performance of a HIPEC
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
Age < 18 years or > 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. <br>Assessment of pharmacokinetic measurements.<br>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.<br>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
- Secondary Outcome Measures
Name Time Method Secondary end point(s): maximal tolerable dose of paclitaxel in combination with carboplatin as HIPEC;<br>effect on disease-free and overall survival after three and five years; effect on life time quality <br>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<br>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<br>effect on tumor tissue: end of study