Predict Response Of Drugs In Ovarian Cancer Treatment Using Organoids

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 239

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.

Patients starting a new line of treatment after participation in this trial are
eligible to participate again. Informed consent, baseline screening, and the
diagnostic biopsy procedure must be repeated.

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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Progression-free survival. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>• Response at first, second, and/or following evaluations after treatment with<br /><br>standard-of-care drugs as measured by the change in tumor size on a CT scan<br /><br>(continuous variable)<br /><br>• Response at patient level according to RECIST 1.1 (categorical variable)<br /><br>• Response at patient level according to CA-125 levels (continuous variable)<br /><br>• Assess above mentioned end-points per specified subgroups:<br /><br>o per treatment line (platinum-naïve, platinum-sensitive, or<br /><br>platinum-resistance)<br /><br>o per histopathological subtype (high-grade serous or others)<br /><br>o per type of treatment given (carboplatin-paclitaxel with or without PARPi or<br /><br>bevacizumab maintenance therapy, carboplatin-gemcitabine with or without PARPi<br /><br>or bevacizumab maintenance therapy, weekly paclitaxel, etoposide,liposomal<br /><br>doxorubicin or early clinical trial compound).<br /><br>• Yield/feasibility of organoid culture and tumor cell line (2D) culture</p><br>