A Phase 2 interventional study of Surgery and carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin... in Ovarian Cancer Recurrent, Fallopian Tube Cancer and Primary Peritoneal Carcinoma, sponsored by Shanghai Gynecologic Oncology Group. Recruiting at 5 sites in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-03-18.
Sponsored by Shanghai Gynecologic Oncology Group · Phase 2, Interventional, and Treatment
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.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's planned enrollment of 167 is above the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Shanghai Gynecologic Oncology Group is the lead sponsor of 15 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Front-line or second-line treatment may have included maintenance therapy (i.e. bevacizumab, PARP inhibitor)
Secondary cytoreductive surgery (SCR) when first recurrence
Exclusion Criteria:
Intervention: Procedure: Maximum effort cytoreductive surgery combined with Niraparib maintenance Drug: Platinum-based chemotherapy and Niraparib
Procedure: Surgery · Drug: carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin... · Drug: Niraparib
Intervention: Drug: Platinum-based chemotherapy and Niraparib
Drug: carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin... · Drug: Niraparib
Tumor debulking surgery (surgery in recurrent ovarian disease)
Also known as: secondary cytoreduction
Salvage chemotherapy
Also known as: third-line therapy
Niraparib maintenance therapy
Also known as: maintenance therapy
12-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
Plan to share: No
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Shanghai Gynecologic Oncology Group