NL-OMON56484尚未招募不适用
Predict Response Of Drugs In Ovarian Cancer Treatment Using Organoids - PRODICT
niversitair Medisch Centrum Utrecht0 个研究点目标入组 239 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 239
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •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.
排除标准
- •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.
研究者
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