A Randomized Prospective Trail of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Recurrent Ovarian Cancer Patients With Mutations in Homologous Recombination Repair (HRR) Genes
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Progression-free Survival
研究概览
简要总结
A phase III prospective study with the primary objective to investigate the benefit of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in ovarian cancer patients with mutations in homologous recombination repair (HRR) genes. The target population for this study is patients with recurrent ovarian, peritoneal or fallopian tube cancers undergoing Cytoreductive Surgery (CRS). Patients will be divided into two groups according to HRR genes mutation, each group will be further divided into two sub-groups with different intervention. Patients in Group A are HRR mutated type, sub-group 1 will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy, sub-group 2 will undergo CRS and then go on to intravenous chemotherapy. Patients in Group B are HRR wild type, sub-group 3 will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy, sub-group 4 will undergo CRS and then go on to intravenous chemotherapy. All patients will receive maintenance therapy with Niraparib after primary treatment. Prognostic information will be collected for investigation of survival benefits of patients.
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
- Double (Participant, Outcomes Assessor)
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
- •age 18-75
- •Karnofsky performance status >50 or World Health Organization performance score < 2
- •primary or recurrence ovarian, peritoneal or fallopian tube epithelial cancer; first intra-abdominal recurrence without distant metastasis (including: unique resectable pleural metastasis which are platinum-sensitive; resectable single lymphatic metastasis retroperitoneal or inguinal)
- •preoperative platinum-based chemotherapy (carboplatin and paclitaxel, carboplatin and liposomal doxorubicin, gemcitabine, trabectedin or topotecan)
- •lesion can be removed completely or residual disease < 0.5 cm
- •last chemotherapy finished no more than 12 weeks after surgery
- •no hepatic function damage
- •white blood cell count ≥3.5*10^9/L; platelet count ≥80*10^9/L; Hemoglobin ≥90g/L
- •no contraindication of surgery and anesthesia
- •life expectancy ≥ 3 months
- •informed consent form signed
排除标准
- •age < 18 or >75
- •no history of other cancer
- •platinum allergy
- •distant metastasis
- •used anti-angiogenic drug within 8 weeks
- •possibility of more than two resection of alimentary canal
- •recurrence < 6 months after primary treatment
- •histologic type: non epithelial origin
- •infection out of control
- •follow-up unable to carry on (geographic or psychic)
- •cardiac insufficiency or respiratory insufficiency
- •has received HIPEC already
- •being in other clinical study
- •pregnancy or lactation period
结局指标
主要结局
Progression-free Survival
时间窗: up to 36 months since diagnosis
The progression-free survival interval was the time between diagnosis and evidence of recurrent or progressive disease.
次要结局
- Overall Survival(up to 36 months since histological diagnosis)
- DP12(the 1 day of histological diagnosis and 12 months after)
- DP9(the 1 day of histological diagnosis and 9 months after)
- Serious adverse events, SAEs(surgery and with in 30 days)
研究者
CAI Hongbing
Dr. Prof.
Zhongnan Hospital