epithelial ovariancarcinoma ovarian cancer ovarian cancer
Conditions
Interventions
Predict drug response in organoids.
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: To be eligible to participate in this study, a subject must meet all of the following criteria: 1. Patients diagnosed with (the suspicion of) epithelial ovarian carcinoma amenable for standard-of-care systemic treatment in the adjuvant or recurrent setting, including, but not limited to: Treatment for primary advanced stage EOC: 1.1. Carboplatin/paclitaxel + PARP inhibitor* (including repeated cycles) 1.2. Carboplatin/gemcitabine + PARP inhibitor* (only if not administered yet) 1.3. Carboplatin/gemcitabine + bevacizumab (including repeated cycles) Treatment for recurrent advanced stage EOC: 1.4. Paclitaxel (weekly) +/- bevacizumab 1.5. Etoposide 1.6. Liposomal doxorubicin 1.7. Early phase clinical trial compound(s) 1.8. Treatments outside the above-mentioned standard-of-care regimens can be considered but must be approved by the study*s P.I. before including patients. * PARP inhibitors incl.: registered olaparib, niraparib and rucaparib. Talazoparib and veliparib are still under investigation in clinical trials. 2. Patients age >=18 years, willing and able to comply with the protocol as judged by the investigator with a signed informed consent. 3. Patients with neoadjuvant treatment or recurrent disease must have radiographically evaluable disease, either measurable or non-measurable per RECIST 1.1, as assessed by the local site investigator/radiology.
Exclusion criteria
Exclusion criteria: • Patients with unrelated secondary tumors that in the opinion of the investigator interfere with treatment decision making, affect response evaluation of pose a competing risk for survival. • Patients who underwent a diagnostic biopsy due to suspicion of EOC, but histological examination did not confirm this diagnosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Response at first, second, and/or following evaluations after treatment with standard-of-care drugs as measured by the change in tumor size on a CT scan (continuous variable) • Response at patient level according to RECIST 1.1 (categorical variable) • Response at patient level according to CA-125 levels (continuous variable) • Assess above mentioned end-points per specified subgroups: o per treatment line (platinum-naïve, platinum-sensitive, or platinum-resistance) o per histopathological subtype (high-grade serous or others) o per type of treatment given (carboplatin-paclitaxel with or without PARPi or bevacizumab maintenance therapy, carboplatin-gemcitabine with or without PARPi or bevacizumab maintenance therapy, weekly paclitaxel, etoposide,liposomal doxorubicin or early clinical trial compound). • Yield/feasibility of organoid culture and tumor cell line (2D) culture | — |
Countries
Netherlands
Contacts
Public ContactREWM Vorst
Universitair Medisch Centrum Utrecht
Outcome results
None listed