Personalised Timing of Interval Debulking Surgery Based on KELIM After Neoadjuvant Chemotherapy in Advanced Ovarian Cancer - a Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Complete resection (CC0) rate
研究概览
简要总结
About 70% of epithelial ovarian cancer patients are diagnosed at advanced stage. When primary optimal surgery is not possible, neoadjuvant chemotherapy will followed by interval debulking surgery is one treatment option. However, there is no consensus on the optimal timing of the surgery. CA125 is a well-known tumor marker in ovarian cancer. Its kinetic change has been proven to correlate with the patients' response to chemotherapy and chance of optimal resection. This study aims to utilize the kinetic change of CA125 to customize the timing of surgery for individual patients.
详细描述
Recruited patients will have additional CA125 at 4th (before administration of chemotherapy), and 5th week after the first cycle of chemotherapy. CA-125 ELIMination Rate Constant K (KELIM) will be determined. Patients with KELIM =>1 will receive radiological assessment and undergo internal debulking surgery if the disease is operable. Patients with KELIM <1 will have alternative management, such as addition of bevacizumab or changing to dose-dense chemotherapy, and defer the interval debulking surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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 must be at least 18 years old.
- •Patients who have Eastern Cooperative Oncology Group (ECOG) score 0-
- •Patients who are competent to give informed consent.
- •Patients who have stage III-IV histologically or cytologically confirmed epithelial ovarian cancer, fallopian tube or primary peritoneal cancer not amenable for primary debulking surgery (PDS).
- •Patients who are planned for neoadjuvant chemotherapy (NACT) using platinum-based chemotherapy +/- bevacizumab or biosimilar. Those who are receiving NACT before interval debulking surgery (IDS) are also eligible.
- •Patients who have an evaluable CA125 level at baseline (i.e., baseline level is at least 2x upper limit of normal).
- •Patients who have baseline computed tomography of at least abdomen and pelvis, or positron emission tomography (PET)-CT. Magnetic resonance imaging (MRI) is also acceptable but the same modality has to be used when assessing the feasibility of IDS.
- •Patients who agree to undergo IDS, where the time of IDS may differ from the usual clinical practice.
- •Patients who agree to receive adjuvant chemotherapy, if clinically indicated. The total number of chemotherapy should be at least four or above.
排除标准
- •Patients who have borderline malignancy, or non-epithelial ovarian cancer like germ cell or sex cord tumor, or metastatic diseases from other origins like Krukenberg's tumor
- •Patients who are eligible for PDS
- •Patients who are not fit for PDS because of medical morbidities or refusal of operation
- •Patients who have already started NACT outside the study centres, except those who have just had one cycle within 21 days and the baseline CA125 is available.
- •Patients who are pregnant
研究组 & 干预措施
Personalised management
Patients will be managed based on CA-125 ELIMination Rate Constant K (KELIM) at the neoadjuvant setting.
干预措施: KELIM (Diagnostic Test)
Personalised management
Patients will be managed based on CA-125 ELIMination Rate Constant K (KELIM) at the neoadjuvant setting.
干预措施: Carboplatin plus Paclitaxel (Drug)
Personalised management
Patients will be managed based on CA-125 ELIMination Rate Constant K (KELIM) at the neoadjuvant setting.
干预措施: Interval debulking surgery (Procedure)
结局指标
主要结局
Complete resection (CC0) rate
时间窗: Up to 24 months
The likelihood of CC0 in patients who undergo IDS when KELIM reaches 1 or above
Sensitivity of KELIM in predicting CC0
时间窗: Up to 24 weeks
The sensitivity of KELIM in predicting CC0
次要结局
- Time required to achieve KELIM >=1(Up to 24 weeks)
- Complication rates of treatment(Up to 1 year)
- Quality-of-life scale(Up to 1 year)
研究者
Dr. Ka-Yu Tse
Prof.
The University of Hong Kong