Identification of Markers of Resistance During Frontline Therapy and Maintenance
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 7
- 主要终点
- minimal residual disease (MRD) status
研究概览
简要总结
The researchers are doing this study to look at the health outcomes of people with advanced ovarian cancer who have a second look laparoscopy (SLL) after they complete their first course of chemotherapy. The researchers will compare the health outcomes of people who have minimal residual disease (MRD-small amounts of cancer cells in the body after a person receives treatment) at the time of SLL with the health outcomes of people who do not have MRD at the time of SLL. The researchers are also doing this study to determine if SLL is safe and practical (feasible) in people with advanced ovarian cancer who have completed the first course of therapy for their disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients assigned female at birth≥ 18 years of age
- •Suspected or known stage III-IV epithelial ovarian cancer for which the patient has undergone, or is planned to undergo, attempted primary or interval debulking surgery
- •Homologous Recombination Deficiency testing should be planned to be completed prior to completion of initial platinum/taxane chemotherapy. HRD testing can be determined using :
- •Confirmation of deleterious Somatic or Germline BRCA mutation
- •CLIA certified test for HRD
- •Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
排除标准
- •Patients with the inability to swallow oral medications or impaired gastrointestinal absorption due to gastrectomy or drainage gastrostomy tube
- •Patients receiving standard of care or investigational protocol directed treatment are eligible for this study, with the exception of protocol directed treatment which would prohibit the SLL surgery from being performed
研究组 & 干预措施
Second Look Laparoscopy (SLL)
Patients will be treated with standard of care observation or maintenance therapy as per investigator decision.The only investigational intervention performed through this study is the SLL.
干预措施: Second Look Laparoscopy (Procedure)
结局指标
主要结局
minimal residual disease (MRD) status
时间窗: up to 12 weeks
will be based on surgicopathological findings from multiple biopsies and peritoneal cytology obtained during the SLL procedure
次要结局
未报告次要终点