Primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy (HIPEC) for FIGO stage III epithelial ovarian cancer: OVHIPEC-2, a phase III randomized clinical trial

Simone Koole, Ruby van Stein, Karolina Sikorska, Desmond Barton, Lewis Perrin, Donal Brennan, Oliver Zivanovic, Berit Jul Mosgaard, Anna Fagotti, Pierre-Emmanuel Colombo, Gabe Sonke, W. J. van Driel*, Roy Lalisang, OVHIPEC-2 Steering Committee, Dutch OVHIPEC group

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

24 Citations (Web of Science)

Abstract

Background

The addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery improves recurrence-free and overall survival in patients with FIGO stage III ovarian cancer who are ineligible for primary cytoreductive surgery. The effect of HIPEC remains undetermined in patients who are candidates for primary cytoreductive surgery.

Primary objective

The primary objective is to evaluate the effect of HIPEC on overall survival in patients with FIGO stage III epithelial ovarian cancer who are treated with primary cytoreductive surgery resulting in no residual disease, or residual disease up to 2.5 mm in maximum dimension.

Study hypothesis

We hypothesize that the addition of HIPEC to primary cytoreductive surgery improves overall survival in patients with primary FIGO stage III epithelial ovarian cancer.

Trial design

This international, randomized, open-label, phase III trial will enroll 538 patients with newly diagnosed FIGO stage III epithelial ovarian cancer. Following complete or near-complete (residual disease

Major eligibility criteria

Patients with FIGO stage III primary epithelial ovarian, fallopian tube, or primary peritoneal cancer are eligible after complete or near-complete primary cytoreductive surgery. Patients with resectable umbilical, spleen, or local bowel lesions may be included. Enlarged extra-abdominal lymph nodes should be negative on FDG-PET or fine-needle aspiration/biopsy.

Primary endpoint

The primary endpoint is overall survival.

Sample size

To detect a HR of 0.67 in favor of HIPEC, 200 overall survival events are required. With an expected accrual period of 60 months and 12 months additional follow-up, 538 patients need to be randomized.

Estimated dates for completing accrual and presenting results

The OVHIPEC-2 trial started in January 2020 and primary analyses are anticipated in 2026.

Original languageEnglish
Pages (from-to)888-892
Number of pages5
JournalInternational Journal of Gynecological Cancer
Volume30
Issue number6
DOIs
Publication statusPublished - Jun 2020

Keywords

  • ovarian cancer
  • surgical oncology
  • peritoneal neoplasms
  • surgical procedures
  • operative
  • LONG-TERM SURVIVAL
  • CISPLATIN

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