Efficacy of HIPEC as NACT and Postoperative Chemotherapy in the Treatment of Advanced-Stage Epithelial Ovarian Cancer (EHNPCTASEOC)
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, Neoadjuvant Chemotherapy, Interval Debulking Surgery, Advanced-Stage Epithelial Ovarian Cancer, Postoperative Chemotherapy
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Department of Abdominal Surgery (Section 2), Affiliated Tumor Hospital of Guangzhou Medical University
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Experimental group
Control 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
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