Abstract 796TiP
Background
The addition of hyperthermic intraperitoneal chemotherapy (HIPEC) during interval cytoreductive surgery improves PFS and OS in stage III ovarian cancer (OV-01 and KOV-01 trials). This trial aims to assess survival benefit of HIPEC in stage III and IV ovarian cancer amidst maintenance therapy with bevacizumab or poly (ADP-ribose) polymerase (PARP) inhibitors.
Trial design
The trial is registered on ClinialTrials.gov (NCT05827523). Ovarian cancer patients will be randomized at the time of interval cytoreductive surgery with residual disease < 2.5mm to receive HIPEC (41.5 cisplatin 75mg/m2, 90 minutes) or not (control arm). After recovery from surgery, patients will receive postoperative platinum-based adjuvant chemotherapy followed by maintenance therapy with bevacizumab or PARP inhibitors. The primary objective of the trial is to evaluate OS in two groups. Secondary objectives are PFS, cancer-specific survival, time to first subsequent therapy (TFST), safety, CA-125 elimination rate constant K (KELIM) score, and quality of life. Assuming that the enrollment period is 5 years and the follow-up period is 3 years, the total number of events required is 263. Based on the log-rank test, the total number of subjects required to prove HR 0.67 with a two-sided alpha of 0.05 and 90% power is 494. 520 patients are finally studied, considering 5% drop-out. Until May 06, 2024, 144 (28.0%) patients are randomized.
Clinical trial identification
NCT05827523.
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
792P - The differences in immunogenicity of TP53 mutated endometrial-, high-grade serous ovarian- and triple negative breast carcinomas
Presenter: Alain Zeimet
Session: Poster session 02
793TiP - A phase III, randomized, open-label, multicenter study of sacituzumab tirumotecan (sac-TMT) monotherapy vs treatment of physician’s choice chemotherapy in patients with endometrial cancer who have received prior chemotherapy and immunotherapy: ENGOT-en23/GOG-3095/MK-2870-005
Presenter: Domenica Lorusso
Session: Poster session 02
795TiP - A first-in-human phase I study of LY4170156, an antibody-drug conjugate targeting folate receptor α (FRα)-expressing advanced solid tumors
Presenter: Isabelle Ray-Coquard
Session: Poster session 02
797TiP - Tislelizumab combined with chemotherapy as neoadjuvant treatment for advanced endometrial cancer: A prospective, single-arm, open-label clinical study
Presenter: Zheng Hu
Session: Poster session 02
798TiP - Stereotactic radiotherapy alone or followed by niraparib for oligometastases or oligoprogression in ovarian cancer following PARP inhibitor therapy: SOPRANO trial
Presenter: Susana Banerjee
Session: Poster session 02
856P - Safety of neoadjuvant PARP inhibitor and immunotherapy in locally advanced HPV-negative head and neck squamous cell carcinoma (PRIME H&N Study)
Presenter: Luigi Lorini
Session: Poster session 02
857P - Safety and efficacy of neoadjuvant immunochemotherapy in patients with locally advanced head and neck squamous cell carcinoma: A prospective single-arm clinical trial
Presenter: Jing Yan
Session: Poster session 02
Resources:
Abstract
858P - Preoperative neoadjuvant chemoimmunotherapy for locally advanced head and neck squamous cell carcinoma patients: A prospective, single-arm, phase II clinical study
Presenter: Ping Han
Session: Poster session 02