Timing of Surgery After Neoadjuvant Chemotherapy for Advanced Ovarian Cancer: A Randomized Clinical Trial for Early Versus Delayed Interval Cytoreductive Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
Ovarian cancer is among the top five primary causes of cancer-related mortality in women. Most ovarian malignant tumours originate from epithelial cells The majority of patients typically have advanced-stage tumours at diagnosis. When complete surgery with no macroscopic visible disease is not feasible due to both the spread of the disease and the patient's general condition, neoadjuvant chemotherapy (NACT) of 3 cycles followed by interval cytoreductive surgery (ICS) or final cytoreductive surgery (FCS) after 6 cycles of NACT followed or not by adjuvant chemotherapy can be offered, with similar overall survival. In our centre, due to logistics, disease, or patient factors, many patients may receive more than 3 cycles of NACT before ICS. Therefore, this randomized controlled trial aims to evaluate the survival benefit of different timings of ICS after 3 or 6 cycles of NACT in patients not eligible for upfront cytoreductive surgery (UCS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female Patients aged 18 to 75 years.
- •International Federation of Gynecology and Obstetrics (FIGO) stage IIIB-IV unsuitable for UCS.
- •Histologically confirmed high-grade serous (HGS) ovarian, fallopian tube, or primary peritoneal carcinoma.
- •ECOG performance status: 0 or
- •Resectable disease by laparoscopic assessment after 3 cycles of NACT.
- •Adequate haematology, bone marrow, respiratory, hepatic, cardiac and renal functions.
- •Estimated life expectancy of > 3 months according to Age-adjusted Charlston Co-morbidity Index (ACCI), included patients should have a low or intermediate comorbidity score; ACCI 0-3.
排除标准
- •Metastatic ovarian carcinoma.
- •Patients with primary ovarian carcinoma other than high-grade serous (low-grade serous, endometrioid, mucinous, clear cell, and non-epithelial ovarian carcinoma).
- •Presence of pregnancy or breast-feeding.
- •History of other invasive malignancies in the previous 5 years.
- •History of a recent < 6 month cerebrovascular accident.
- •Uncontrolled systemic disease or contraindication to chemotherapy.
- •Progressive disease on NACT.
- •Worsening Eastern Cooperative Oncology Group (ECOG) Performance Status (ECOG 2-4).
- •Severe comorbidities (ACCI >= 4)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: up to 5years
PFS will be defined as the time to recurrence/progression, or the date of death. Disease recurrence/ progression is defined as an increase in cancer antigen 125 (CA 125) levels or evidence of recurrence by imaging and/or histology.
Overall survival (OS)
时间窗: up to 5 years
OS will be defined as the time until the patient's death from any cause. The time to event occurrence will be calculated from the time of randomization until the event of interest.
次要结局
- Tumour recurrence and death(Up to 5 years)
- Surgical complexity scoring (low, intermediate, or high)(3-6 months)
- Post-operative morbidity(within 30 days of surgery)
- Operative peritoneal cancer index (PCI) assessment(3-6 months)
- Complete resection rate(3-6 months)
- Pathological complete chemotherapy response score (CRS 3)(3-6 months)
- The total number of chemotherapy cycles administered(8 months)