Post-operative intraperitoneal chemotherapy after interval cytoreduction in epithelial ovarian cancer (POICE 2024): multicenter, randomized, phase III trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 342
- 试验地点
- 11
- 主要终点
- relapse free survival
研究概览
简要总结
This is a study which will be done in patients with advanced epithelial ovarian cancer who have received 3-4 cycles of chemotherapy with paclitaxel and carboplatin prior to surgery and now planned for surgery. The patients who are eligible and who provide informed consent will undergo standard cytoredcutive surgery. After surgery, if optimal cyoreduction is done, they will be randomised to one of the 2 groups. In group 1 (intervention) they will receive 100 mg per m2 of cisplatin intraperitoneally which will be evacuated after a period of 60 minutes. In group 2, there will be surgery only and no intraperitoneal therapy will be applied. Both groups will receive standard postoperative care. Subsequently they will be followed up till completion of their remaining cycles of (total 6 cycles) of IV chemotherapy. Subseuquently both groups will be followed up as per standard process for the next 3 years to see whether there is any relapse. The relapse free survival between the two groups will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patient giving informed consent Newly diagnosed FIGO stage 3 or 4a epithelial ovarian cancer After optimal cytoreduction after interval surgery Must have received 3 or 4 cycles of paclitaxel nd carboplatin neoadjuvant chemotherapy ECOG performance status 0 or 1 at enrolment Negative pregnancy test in women of child bearing potential adequate organ function.
排除标准
- •Prior surgery for ovarian cancer other than biopsies Serious medical illnesses Uncontrolled infections Pre existing neuropathy more than grade 1 Known to have borderline or low grade cancer Prior partial therapy elsewhere intraoperative complications rendering patient unfit for IP chemotherapy Time from last chemotherapy to surgery less than 8 weeks Bevacizumab as part of neoadjuvant schedule.
结局指标
主要结局
relapse free survival
时间窗: 3 years
次要结局
- overall survival(3 years)
- toxicity of therapy(6 months)
- surgical morbidity(1 month)
- quality of life(6 months)
研究者
Prasanth Ganesan
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)