Status:
UNKNOWN
Efficacy of HIPEC in the Treatment of Advanced-Stage Epithelial Ovarian Cancer After Cytoreductive Surgery
Lead Sponsor:
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Collaborating Sponsors:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Third Affiliated Hospital, Sun Yat-Sen University
Conditions:
Epithelial Ovarian Cancer
Fallopian Tube Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
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 epitheli...
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 intraper...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2023
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT03373058
Start Date
October 15 2019
End Date
July 1 2023
Last Update
November 6 2019
Active Locations (7)
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1
Affiliated Tumor Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510095
2
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Guanzhou, Guangdong, China, 510235
3
Beijing Cancer Hospital
Beijing, China
4
Chongqing Cancer Hospital
Chongqing, China