This is a Phase II, open-label, multicenter, randomized umbrella study to evaluate the efficacy of cytoreductive surgery and Niraparib maintenance in participants with platinum-sensitive secondary recurrent ovarian cancer. Cohort 1 will focus on participants without prior use of PARP inhibitor, and without prior secondary cytoreduction (SCR) when first recurrence. Cohort 2 will focus on participants with prior use of PARP inhibitor, but without prior SCR when first recurrence. Cohort 3 will focus on participants with SCR when first recurrence, but without prior use of PARP inhibitor.
This exploratory trial is to compare the efficacy of secondary cytoreductive surgery followed by chemotherapy and Niraparib maintenance, versus chemotherapy alone followed by Niraparib maintenance in patients with platinum-sensitive secondary recurrent ovarian cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
167
Fudan University Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGSun Yat-sen University Cancer Center
Guangzhou, China
NOT_YET_RECRUITINGZhejiang Cancer Hospital
Hangzhou, China
NOT_YET_RECRUITINGFudan University
Shanghai, China
NOT_YET_RECRUITINGShanghai Jiao Tong University
Shanghai, China
NOT_YET_RECRUITING12-month disease non-progression rate
12-month non-progression rate
Time frame: up to 12 months after last patient randomized
Progression-free survival
from date of randomization until the date of 3rd relapse/progression or death (whatever occurs first)
Time frame: Up to 24 months after last patient randomized
Treatment free survival
It is the area between Kaplan-Meier curves for two time-to-event end points: 1) time to protocol chemotherapy cessation and 2) time to first subsequent anticancer therapy initiation or death, whichever occurred first.
Time frame: Up to 24 months after last patient randomized
Overall survival
from date of randomization until the date of death from any cause
Time frame: Approximately up to 24 months after last patient randomized
30-day post-operative complications
surgical complications grading criteria will be adopted for evaluating the perioperative complications
Time frame: From the operation until after 30 days
Quality of life assessment
the European Organization for Research and Treatment (EORTC) core quality of life questionnaire (QLQ-C30, version 3.0) The total score (range from 0 to 1,000)
Time frame: baseline; 6 and 12 months after randomization
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