Efficacy of HIPEC in the Treatment of Advanced-Stage Epithelial Ovarian Cancer After Cytoreductive Surgery
- Conditions
- Epithelial Ovarian CancerFallopian Tube CancerPrimary Peritoneal Carcinoma
- Interventions
- Procedure: Hyperthermic Intraperitoneal ChemotherapyProcedure: cytoreductive surgeryDrug: adjuvant chemotherapy
- Registration Number
- NCT03373058
- Lead Sponsor
- Affiliated Cancer Hospital & Institute of Guangzhou Medical University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 310
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group Hyperthermic Intraperitoneal Chemotherapy 1. Cytoreductive surgery 2. Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Docetaxel 75 mg/m\^2 and cisplatin 75 mg/m\^2 intraperitoneally in succession 3. 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. Experimental group cytoreductive surgery 1. Cytoreductive surgery 2. Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Docetaxel 75 mg/m\^2 and cisplatin 75 mg/m\^2 intraperitoneally in succession 3. 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. Experimental group adjuvant chemotherapy 1. Cytoreductive surgery 2. Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Docetaxel 75 mg/m\^2 and cisplatin 75 mg/m\^2 intraperitoneally in succession 3. 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. Control group cytoreductive surgery 1. Cytoreductive surgery 2. 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. Control group adjuvant chemotherapy 1. Cytoreductive surgery 2. 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.
- Primary Outcome Measures
Name Time Method Median recurrence-free survival 3 years assess median recurrence-free survival during 3 years in both study arms
- Secondary Outcome Measures
Name Time Method Median overall survival 3 years assess median overall survival during 3 years in both study arms
Median progression-free survival 3 years assess median progression-free survival during 3 years in both study arms
Risk factors for morbidity and mortality 30 days; 3 years The early complication and mortality are defined as the event observed within 30 days after intervention, while the time frame for late complication is the period beyond 30 days after intervention to the end of 3 years. Complications are ranked from grade 0-5 according to CTCAE V4.0
Quality of life for ovarian cancer 3 years Evaluated according to European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Ovarian Cancer Module (QLQ-OV28)
Trial Locations
- Locations (7)
Affiliated Tumor Hospital of Guangzhou Medical University
🇨🇳Guangzhou, Guangdong, China
Henan Cancer Hospital
🇨🇳Zhengzhou, China
Beijing Cancer Hospital
🇨🇳Beijing, China
Chongqing Cancer Hospital
🇨🇳Chongqing, China
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
🇨🇳Guanzhou, Guangdong, China
The First Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, China
Hubei General Hospital
🇨🇳Wuhan, China