C56
Conditions
Interventions
Group 1: After inclusion to the study, the patients will be treated either with a topotecan or a liposomal doxorubicin mono-therapy, based upon either the medical circumstances as judged by the invest
while a further part of the sample will be sent to pathology for pathological examination. All patients will be subsequently treated with topotecan or liposomal doxorubicin. The investigating physicia
Sponsors
TherapySelect GmbH & Co KG
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Patients = 18 years with a histologically verified ovarian cancer - Patients must have elevated CA 125 levels (> 70 U/ml); a follow-up of these laboratory parameters must be medically indicated - In the case of first-time affection: o A chemotherapy carboplatin and paclitaxel is indicated - In the case of a recurrence: o Pre-treatment with platinum-based mono or combination therapy o A mono-therapy consisting of topotecan or liposomal doxorubicin (e.g. Caelyx®) is indicated (no progression having previously occurred while using the applied substance) - A puncture to extract the existing ascites or preural effusion and/or a surgical intervention for the extraction of tumor tissue must be medically indicated - Patients must geographically situated in a manner to be able to participate in treatment - Tumor cell count of the extracted ascites/preura punctate or tumor tissue: = 5 x 106 cells - ECOG status = 2 - Written consent for participation in the study after the patient has been well informed about the content and purpose of the evaluation of performance assessment and has understood it
Exclusion criteria
Exclusion criteria: - Ovarian tumors with low malignant potential (e.g. borderline tumors) - Non-epithelial ovarian tumors or mixed tumors (e.g. Mueller'scher mixed tumor) - Patients who have received radiation therapy and/or chemotherapy and/or immunotherapy within three weeks prior to puncture - Patients who have had another diagnosed malignancy within the past 5 years which could not be resolved through surgery alone (except CIS of the cervix or adequately treated basal cell carcinoma of the skin) - The concurrent application of another neoplastic therapy (chemotherapeutics, hormone therapeutics, or immunotherapeutics), or concurrent radiotherapy during the course of treatment of the study (hormone replacement therapy (HRT), steroid antiemetics, for example, are permitted) - Dementia or a severe change in mental status impairing the patient's ability to comprehend the study or to consent to participation - Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigation of the predictive value of the biochip test (TherapySelect GmbH & Co KG, Heidelberg) in the prediction of a therapeutic response, defined as composite outcome (CA 125 response, imaging findings and/or clinical assessment) | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of the predictive value of the genchip test for epigenetic analysis through the CTR®-test and the combination of tests for the therapeutic response. Investigation of the diagnostic precision under the use of RECIST or CA 125 criteria only. | — |
Countries
Germany
Contacts
Public ContactGülten Oskay-Özcelik
Studienzentrum Eierstockkrebs Leitzentrale der AG Ovarialkarzinom der NOGGO e. V. Klinik für Frauenheilkunde und Geburtshilfe Charité Campus Virchow-Klinikum
Outcome results
None listed