A Phase III Multicenter Prospective Randomized Controlled Clinical Trial of HIPEC as NACT and Postoperative Chemotherapy After Interval Debulking Surgery in the Treatment of Advanced-Stage Epithelial Ovarian Cancer
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 263
- 试验地点
- 1
- 主要终点
- Percentage of optimal debulking surgery
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 as neoadjuvant chemotherapy(NACT) and postoperative chemotherapy after interval debulking surgery (IDS) for advanced-stage epithelial ovarian cancer . PR/SD rate, percentage of optimal debulking surgery and 3-year disease-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 a high perioperative risk profile or a low likelihood of achieving cytoreduction to < 1 cm of residual disease (ideally to novisible disease) should receive neoadjuvant chemotherapy.
Hyperthermia promotes chemotherapy to penetrate deeper into the cancer tissue. Therefore, hyperthermic intraperitoneal chemotherapy (HIPEC) as neoadjuvant chemotherapy and postoperative chemotherapy after interval debulking 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
- Single (Participant)
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 and IV)
- •Fagotti score by laparoscopic exploration >= 6
- •After receiving HIPEC+neoadjuvant chemotherapy (NACT) or NACT alone, the curative effects evaluated according to RICIST criteria is partial remission (PR) and stable disease (SD).
- •Residual tumor < 1cm after completion of interval debulking 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
- •After receiving HIPEC+neoadjuvant chemotherapy (NACT) or NACT alone, the progression of disease (PD) is evaluated by doctor.
- •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
- Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with paclitaxel 175 mg/m^2 and cisplatin 75 mg/m^2 intraperitoneally in succession
- 2 cycles of neoadjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks
- Interval debulking surgery
- Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with paclitaxel 175 mg/m^2 and cisplatin 75 mg/m^2 intraperitoneally in succession
- 2 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks
干预措施: Hyperthermic Intraperitoneal Chemotherapy (Procedure)
Experimental group
- Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with paclitaxel 175 mg/m^2 and cisplatin 75 mg/m^2 intraperitoneally in succession
- 2 cycles of neoadjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks
- Interval debulking surgery
- Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with paclitaxel 175 mg/m^2 and cisplatin 75 mg/m^2 intraperitoneally in succession
- 2 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks
干预措施: Interval debulking surgery (Procedure)
Experimental group
- Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with paclitaxel 175 mg/m^2 and cisplatin 75 mg/m^2 intraperitoneally in succession
- 2 cycles of neoadjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks
- Interval debulking surgery
- Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with paclitaxel 175 mg/m^2 and cisplatin 75 mg/m^2 intraperitoneally in succession
- 2 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks
干预措施: neoadjuvant chemotherapy (Drug)
Experimental group
- Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with paclitaxel 175 mg/m^2 and cisplatin 75 mg/m^2 intraperitoneally in succession
- 2 cycles of neoadjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks
- Interval debulking surgery
- Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with paclitaxel 175 mg/m^2 and cisplatin 75 mg/m^2 intraperitoneally in succession
- 2 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks
干预措施: adjuvant chemotherapy (Drug)
Control group
- 3 cycles of neoadjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks
- Interval debulking surgery
- 3 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks
干预措施: Interval debulking surgery (Procedure)
Control group
- 3 cycles of neoadjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks
- Interval debulking surgery
- 3 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks
干预措施: neoadjuvant chemotherapy (Drug)
Control group
- 3 cycles of neoadjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks
- Interval debulking surgery
- 3 cycles of adjuvant chemotherapy: paclitaxel 175 mg/m^2 IV>3 hour+ 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
Percentage of optimal debulking surgery
时间窗: Through study completion, an average of 1 year
evaluate the percentage of optimal debulk (residual disease \< 1cm) after interval debulking surgery between study arms
PR/SD rate
时间窗: Through study completion, an average of 1 year
calculate the percent of partial remission (PR) plus stable disease (SD) of patients received HIPEC+NACT or NACT alone in both two arms
Disease-free survival rate
时间窗: 3 years
assess disease free survival rate during 3 years in both study arms
次要结局
- Overall survival rate(3 years)
- Risk factors for morbidity and mortality(Through study completion, an average of 1 year)
- Quality of life(3 years)
- Quality of life for ovarian cancer(3 years)
研究者
Shu-Zhong Cui
President of Affiliated Tumor Hospital of Guangzhou Medical University
Affiliated Cancer Hospital & Institute of Guangzhou Medical University