A Phase III Clinical Trail of Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Overall Survival rate
研究概览
简要总结
A phase III prospective study with the primary objective to compare the efficacy and safety of HIPEC( Hyperthermic Intraperitoneal Chemotherapy). The target population for this study is patients with primary or recurrence ovarian, peritoneal or fallopian tube cancers undergoing CRS( Cytoreductive Surgery). Patients will be divided into two groups. Group A will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy. Group B will undergo CRS and then go on to intravenous chemotherapy.
详细描述
This is a phase III prospective study with the primary objective to compare the efficacy and safety of HIPEC. The target population for this study is patients with primary or recurrence ovarian, peritoneal or fallopian tube cancers undergoing CRS. 'Platinum-sensitive' recurrence is defined as recurrence 6 months after the completion of the primary platinum-based chemotherapy. A single dose of lobaplatin 40mg/m2 will be administered via HIPEC , and will be administered at the time of surgery, 3 days after surgery and 5 days after surgery. Patients of group A will undergo CRS plus HIPEC and then go on to receive standard platinum-based combination doublet intravenous chemotherapy (carboplatin and paclitaxel, carboplatin and gemcitabine, or carboplatin and liposomal doxorubicin) for 6 cycles. Patients of group B will undergo CRS and then go on to intravenous chemotherapy.
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
- All
- 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
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
Overall Survival rate
时间窗: 5 years
assess overall survival rate in 5 years in both arms
1 year survival rate
时间窗: 1 year
assess the survival rate in 1 year for both arms
3 year survival rate
时间窗: 3 years
assess the survival rate in 3 years for both arms
次要结局
- Progression-free survival(5 years)
- quality of life(5 years after CRS or until death)
- postoperative complication(5 years)
研究者
CAI Hongbing
Professor of Wuhan University, MD, PhD, Chef of the Department of Gynecological Oncology of Zhongnan Hospital, member of the standing committee of Chinese Gynecologic Cancer Society
Zhongnan Hospital