820TiP - A randomized phase II study of secondary cytoreductive surgery (CRS) in patients with relapsed ovarian cancer who have progressed on PARP inhibitor maintenance (KGOG 3067/SOCCER-P trial)

Background

Although recent two phase 3 randomized controlled trials showed survival benefit of secondary cytoreductive surgery (CRS) in first relapsed ovarian cancer, the patients who received PARP inhibitor (PARPi) as first-line maintenance were not included in these trials. In addition, the treatment consensus for recurrence after PARPi has not been established because subsequent platinum-based chemotherapy is not sensitive in relapsed patients after PARPi maintenance. Therefore, there is a significant need for optimal strategy including secondary CRS in patients whose cancer progresses while using a PARPi. The aim of SOCCER-P is to find out whether secondary CRS is beneficial in patients who have progressed on PARPi maintenance.

Trial design

It is a multicenter, randomized phase II trial of secondary CRS in patients with relapsed ovarian cancer who have progressed on PARPi. This trial included patients with the first recurrence of platinum-sensitive ovarian cancer who had a progression-free interval of at least 6 months after the end of the last platinum-containing therapy and progressed on PARPi maintenance. Patients who are considered likely to be completely resected according to the international model (AGO or iMODEL) or based on a consensus between the surgeon and designated radiologist are eligible for this study. 124 subjects are randomly assigned to undergo secondary CRS and subsequent chemotherapy (carboplatin [AUC 5, day 1] plus pegylated liposomal doxorubicin [30 mg/m2, day 1] every 4 weeks) plus or minus bevacizumab (six cycles of bevacizumab [10 mg/kg, days 1 and 15] followed by maintenance bevacizumab [15 mg/kg every 3 weeks]), or to receive chemotherapy plus or minus bevacizumab alone. The primary endpoints were progression-free survival (PFS). And we also assess overall survival and PFS2 defined as the time from randomization to tumor progression on a next-line tretment or death. A one-sided log-rank test with an overall sample size of 124 subjects (62 in the control group and 62 in the treatment group) achieves 80.1% power at a 0.100 significance level to detect a hazard ratio of 0.6500 when the hazard rate of control group is 1.05.

Clinical trial identification

NCT05704621.

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Chong Kun Dang Pharmaceutical Corp.

Disclosure

All authors have declared no conflicts of interest.