Efficacy of HIPEC in the Treatment of Advanced-Stage Epithelial Ovarian Cancer After Cytoreductive Surgery (EHTASEOCCS)
Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Carcinoma
About this trial
This is an interventional treatment trial for Epithelial Ovarian Cancer focused on measuring Hyperthermic Intraperitoneal Chemotherapy, Advanced-Stage Epithelial Ovarian Cancer, Cytoreductive surgery, Postoperative Chemotherapy
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Affiliated Tumor Hospital of Guangzhou Medical UniversityRecruiting
- Sun Yat-sen Memorial Hospital,Sun Yat-sen UniversityRecruiting
- Beijing Cancer HospitalRecruiting
- Chongqing Cancer HospitalRecruiting
- The First Affiliated Hospital of Chongqing Medical UniversityRecruiting
- Hubei General HospitalRecruiting
- Henan Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Experimental group
Control 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.
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.