Efficacy of HIPEC in the Treatment of Advanced-Stage Epithelial Ovarian Cancer After Cytoreductive Surgery
NCT ID: NCT03373058
Last Updated: 2019-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
310 participants
INTERVENTIONAL
2019-10-15
2023-07-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental group
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.
Hyperthermic Intraperitoneal Chemotherapy
HIPEC is performed as postoperative chemotherapy after cytoreductive surgery for advanced-stage epithelial ovarian cancer. The first HIPEC is conducted within 48h after cytoreductive surgery: Paclitaxel 175 mg/m\^2, 43°C, 90min. The second HIPEC is performed after 48 hours of the first HIPEC. The HIPEC regimens are Docetaxel 75 mg/m\^2 and cisplatin 75 mg/m\^2, respectively, 43°C, 90min.
cytoreductive surgery
Cytoreductive surgery (CRS) is performed when Faggoti value is less than 6 via laparoscopic exploration.
adjuvant chemotherapy
Systemic chemotherapy regimens after HIPEC treatment are paclitaxel 175 mg/m\^2 IV\>3 hour+ carboplatin AUC = 5-6 IV\>1 hour, every 3 weeks for 2 cycles in experimental group.
Systemic chemotherapy regimens after IDS are paclitaxel 175 mg/m\^2 IV\>3 hour+ carboplatin AUC = 5-6 IV\>1 hour, every 3 weeks for 3 cycles in control group.
Control group
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.
cytoreductive surgery
Cytoreductive surgery (CRS) is performed when Faggoti value is less than 6 via laparoscopic exploration.
adjuvant chemotherapy
Systemic chemotherapy regimens after HIPEC treatment are paclitaxel 175 mg/m\^2 IV\>3 hour+ carboplatin AUC = 5-6 IV\>1 hour, every 3 weeks for 2 cycles in experimental group.
Systemic chemotherapy regimens after IDS are paclitaxel 175 mg/m\^2 IV\>3 hour+ carboplatin AUC = 5-6 IV\>1 hour, every 3 weeks for 3 cycles in control group.
Interventions
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Hyperthermic Intraperitoneal Chemotherapy
HIPEC is performed as postoperative chemotherapy after cytoreductive surgery for advanced-stage epithelial ovarian cancer. The first HIPEC is conducted within 48h after cytoreductive surgery: Paclitaxel 175 mg/m\^2, 43°C, 90min. The second HIPEC is performed after 48 hours of the first HIPEC. The HIPEC regimens are Docetaxel 75 mg/m\^2 and cisplatin 75 mg/m\^2, respectively, 43°C, 90min.
cytoreductive surgery
Cytoreductive surgery (CRS) is performed when Faggoti value is less than 6 via laparoscopic exploration.
adjuvant chemotherapy
Systemic chemotherapy regimens after HIPEC treatment are paclitaxel 175 mg/m\^2 IV\>3 hour+ carboplatin AUC = 5-6 IV\>1 hour, every 3 weeks for 2 cycles in experimental group.
Systemic chemotherapy regimens after IDS are paclitaxel 175 mg/m\^2 IV\>3 hour+ carboplatin AUC = 5-6 IV\>1 hour, every 3 weeks for 3 cycles in control group.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
FEMALE
No
Sponsors
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Third Affiliated Hospital, Sun Yat-Sen University
OTHER
Henan Provincial People's Hospital
OTHER
Xiangya Hospital of Central South University
OTHER
The Third Xiangya Hospital of Central South University
OTHER
Peking University Cancer Hospital & Institute
OTHER
Peking University People's Hospital
OTHER
Cancer Hospital of Guizhou Province
OTHER
Chinese PLA General Hospital
OTHER
Hebei Medical University Fourth Hospital
OTHER
The Second Hospital of Hebei Medical University
OTHER
West China Second University Hospital
OTHER
Peking Union Medical College Hospital
OTHER
First Affiliated Hospital, Sun Yat-Sen University
OTHER
Henan Cancer Hospital
OTHER_GOV
Tianjin Medical University Cancer Institute and Hospital
OTHER
The Third Affiliated Hospital of Guangzhou Medical University
OTHER
Wuhan University
OTHER
RenJi Hospital
OTHER
Obstetrics & Gynecology Hospital of Fudan University
OTHER
Southern Medical University, China
OTHER
Fourth Affiliated Hospital of Guangxi Medical University
OTHER
Shandong Cancer Hospital and Institute
OTHER
Beijing Obstetrics and Gynecology Hospital
OTHER
Chongqing University Cancer Hospital
OTHER
Xinqiao Hospital of Chongqing
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
First Affiliated Hospital of Chongqing Medical University
OTHER
Affiliated Cancer Hospital of Shantou University Medical College
OTHER
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
OTHER
Responsible Party
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Principal Investigators
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Shuzhong Cui, M.D
Role: STUDY_DIRECTOR
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Zhongqiu Lin, M.D
Role: STUDY_DIRECTOR
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Locations
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Affiliated Tumor Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Guanzhou, Guangdong, China
Beijing Cancer Hospital
Beijing, , China
Chongqing Cancer Hospital
Chongqing, , China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, , China
Hubei General Hospital
Wuhan, , China
Henan Cancer Hospital
Zhengzhou, , China
Countries
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Central Contacts
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Facility Contacts
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Yunong Gao, MD
Role: primary
Li Wang, MD
Role: primary
Other Identifiers
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HIPEC-03
Identifier Type: -
Identifier Source: org_study_id
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