The purpose of this study is to evaluate the role of an additional intraperitoneal chemotherapy with cisplatin and etoposide in bulky advanced epithelial ovarian cancer.
This exploratory trial is to compare the efficacy of sequential chemotherapy, intraperitoneal chemotherapy followed by intravenous chemotherapy, versus intravenous chemotherapy alone in the first-line therapy for ovarian cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
215
IP: cisplatin 50mg/m2 and etoposide 100mg/m2, weekly, 4 times; 14 days later IV: paclitaxel 175mg/m2 plus carboplatin AUC 5 or docetaxel 60-75mg/m2 plus carboplatin AUC 5
IV: paclitaxel 175mg/m2 plus carboplatin AUC 5 or docetaxel 60-75mg/m2 plus carboplatin AUC 5
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China
Suzhou Municipal Hospital
Suzhou, Jiangsu, China
Wuxi Cancer Hospital
Wuxi, Jiangsu, China
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China
12-month disease non-progression rate
Time frame: 12 months
Progression-free survival
Time frame: up to 120 months
Completion rate of intraperitoneal chemotherapy.
Time frame: up to 6 months
Quality of life assessments
Time frame: baseline; 4th week of intraperitoneal,chemotherapy, 6th cycle of intravenous chemotherpy, 3, 6, and 12 months after first-line chemotherapy.
Overall Survival
Time frame: up to 120 months
adverse effects
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 5 weeks
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Ren Ji Hospital Affiliated to Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanghai Frist Maternity and Infant Hospital Affiliated to Tongji University
Shanghai, Shanghai Municipality, China
Fudan University Cancer Hospital
Shanghai, China