Evaluation of secondary cytoreduction surgery in platinum-resistant ovarian cancer patients within three-line recurrent: a multicenter, randomized controlled study
- Author:
Tingting CHEN
1
;
Junfen XU
;
Bairong XIA
;
Hui WANG
;
Yuanming SHEN
Author Information
- Publication Type:Clinical Trial Protocol
- From:Journal of Gynecologic Oncology 2024;35(1):e22-
- CountryRepublic of Korea
- Language:English
-
Abstract:
Background:Epithelial ovarian cancer is the leading cause of death among gynecological malignancies. Platinum resistance remains a dilemma and bottleneck in treatment, and salvage chemotherapy has limited effectiveness. Recently, the role of secondary cytoreductive surgery (SCS) in patients with platinum-resistant recurrent ovarian cancer (ROC) has caused attention especially in patients with oligometastases. However, there is neither high-quality evidence-based evidence nor standardized criteria for selecting SCS for patients with platinum-resistant ROC until now.
Methods:This multicenter, randomized, controlled clinical trial is to evaluate the value of SCS and to clarify reliable criteria of utilizing SCS in women with ROC, which is led by Gynecologic Oncology Group, Women’s Hospital, Zhejiang University School of Medicine.Recruitment has started on January 1st, 2023, and is scheduled to end in December 2026.One hundred and forty participants with platinum-resistant ROC who meet the “RSCS criteria” will be randomized assigned at a ratio of 1:1 to either the experimental arm or the standard arm. Patients in the experimental arm will receive SCS followed by non-platinum single agent chemotherapy (paclitaxel, gemcitabine or liposomal adriamycin) for at least 4 cycles while patients in the standard arm will be provided with only non-platinum single agent chemotherapy. The primary outcome is progression-free survival. The secondary outcomes are overall survival, adverse events and health-related cancer-specific quality of life.
