NL-OMON54137招募中不适用
Tumoroids in cervical cancer: tumor cultures to test sensitivity for treatment and to compare with clinical outcomes after neo-adjuvant therapy. - Tumoroids in cervical cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 12
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
- •Patients are eligible for this study in case they meet the following inclusion
- •Patients must have histologically confirmed invasive cervical cancer with
- •adenocarcinoma, adenosquamous or squamous histology and FIGO 2018 IB2 measuring
- •>2cm to <=4cm by magnetic radiological imaging (MRI). Lymphovascular space
- •invasion (LVSI) is allowed.
- •Patients must be >=18 years of age, and < 40 years of age
- •Patients must be premenopausal and wish to preserve fertility
- •At time of registration, patient may not have had any prior therapy to treat
- •their cancer lesion, patients with diagnostic cone or LEEP are allowed
- •Eastern Cooperative Group (ECOG) performance status <= 2 (Karnofsky >=60%, see
- •Appendix C).
- •No evidence of active uncontrolled infection (patients on antibiotics are
- •Patient must have disease that is measurable per RECIST 1.1.
- •Ability to understand and willing to sign a written informed consent document.
- •Patients must agree to use effective contraceptive methods prior to study
- •entry, during study participation, and for at least one year after the FSS
排除标准
- •Exclusion criteria for this study:
- •Patients who have had chemotherapy or radiotherapy or surgery for their
- •cancer. Patients with diagnostic cone or LEEP are allowed
- •Patients who are receiving any other investigational agents.
- •Patients with other cancers requiring ongoing treatment. Patients with
- •malignancies unrelated to their cervical cancer can be included if they have
- •not required treatment for 2 years. Patient with baso cellular skin cancer are
- •Patients with known / evidence of brain metastases are excluded from
- •participation in this clinical trial.
- •History of allergic reactions attributed to compounds of similar chemical or
- •biologic composition to paclitaxel, carboplatin, or cisplatin or other agents
- •used in study.
- •Uncontrolled inter-current illness including, but not limited to, ongoing or
- •active infection, symptomatic congestive heart failure, unstable angina
- •pectoris, cardiac arrhythmia, or psychiatric illness/social situations that
- •would limit compliance with study requirements.
- •Patients who are pregnant or breastfeeding
- •Any other condition that would, in the Investigator*s judgment,
- •contraindicate the patient*s participation in the clinical study due to safety
- •concerns or compliance with clinical study procedures, e.g.,
- •infection/inflammation, intestinal obstruction, unable to swallow medication,
- •social/ psychological issues.
研究者
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