A Phase III Multicenter Prospective Randomized Controlled Clinical Trial of Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Advanced-Stage Epithelial Ovarian Cancer After Cytoreductive Surgery
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 310
- 试验地点
- 7
- 主要终点
- Median recurrence-free survival
研究概览
简要总结
This project is a multi-center, prospective, randomized controlled clinical observation the safety and efficacy of hyperthermic intraperitoneal chemotherapy in the treatment of advanced-stage epithelial ovarian cancer after cytoreductive surgery. Median recurrence-free survival is the primary end points of this project.
详细描述
The current standard treatment for epithelial ovarian cancer, tubal cancer, and primary peritoneal cancer is maximal cytoreductive surgery followed by intravenous chemotherapy with or without intraperitoneal chemotherapy (IP). Recently, the organizations of SGO and ASCO recommended that women with Fagotti score by laparoscopic exploration < 6 would benefit from primary cytoreductive surgery followed by postoperative chemotherapy, and are likely to attain optimal cytoreduction (residual lesion ≤ 1 cm).
Hyperthermia promotes chemotherapy to penetrate deeper into the cancer tissue. Therefore, hyperthermic intraperitoneal chemotherapy (HIPEC) as newly postoperative chemotherapy after primary cytoreductive surgery in the treatment of ovarian cancer could lead to higher response rate and better survival outcomes.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Disease status primary epithelial ovarian cancer, tubal cancer, and primary peritoneal cancer (Stage III )
- •Fagotti score by laparoscopic exploration < 6
- •Residual tumor < 1cm after completion of cytoreductive surgery
- •18 < Age < 70 year old
- •Expected survival > 3 months
- •Performance status: ECOG 0-1
- •Adequate bone marrow function Hb ≥8 g/dl (After correction in case of iron deficient anemia) WBC ≥ 3,000/mm3, Platelet ≥ 100,000/mm3
- •Adequate renal function Creatinine ≤ 1.5 mg/dl, and adequate hepatic function Bilirubin ≤ 1.5 mg/dl and AST and ALT ≤ 80 IU/L
- •Voluntary participation after getting written informed consent.
排除标准
- •Fagotti score by laparoscopic exploration >= 6
- •Suboptimal debulking (residual tumor > 1cm)
- •Extensive adhesion in peritoneal cavity
- •Previous History of other malignancies (except excision of skin cancer, thyroid cancer)
- •Poorly controlled disease e.g. atrial fibrillation, stenocardia, cardiac insufficiency, persistent hypertension despite medicinal treatment, ejection fraction<50%
- •Receiving other chemotherapy, radiotherapy or immunotherapy
- •Patients who are unsuitable candidates by doctor's decision
- •Without given written informed consent
研究组 & 干预措施
Experimental group
- Cytoreductive surgery
- Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Docetaxel 75 mg/m^2 and cisplatin 75 mg/m^2 intraperitoneally in succession
- 6 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour(Docetaxel 75 mg/m^2, if paclitaxel is not available.)+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks.
干预措施: Hyperthermic Intraperitoneal Chemotherapy (Procedure)
Experimental group
- Cytoreductive surgery
- Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Docetaxel 75 mg/m^2 and cisplatin 75 mg/m^2 intraperitoneally in succession
- 6 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour(Docetaxel 75 mg/m^2, if paclitaxel is not available.)+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks.
干预措施: cytoreductive surgery (Procedure)
Experimental group
- Cytoreductive surgery
- Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Docetaxel 75 mg/m^2 and cisplatin 75 mg/m^2 intraperitoneally in succession
- 6 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour(Docetaxel 75 mg/m^2, if paclitaxel is not available.)+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks.
干预措施: adjuvant chemotherapy (Drug)
Control group
- Cytoreductive surgery
- 6 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour(Docetaxel 75 mg/m^2, if paclitaxel is not available)+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks.
干预措施: cytoreductive surgery (Procedure)
Control group
- Cytoreductive surgery
- 6 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour(Docetaxel 75 mg/m^2, if paclitaxel is not available)+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks.
干预措施: adjuvant chemotherapy (Drug)
结局指标
主要结局
Median recurrence-free survival
时间窗: 3 years
assess median recurrence-free survival during 3 years in both study arms
次要结局
- Median overall survival(3 years)
- Median progression-free survival(3 years)
- Risk factors for morbidity and mortality(30 days; 3 years)
- Quality of life for ovarian cancer(3 years)