Research
Print page Print page
Switch language
Rigshospitalet - a part of Copenhagen University Hospital
Published

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

Research output: Contribution to journalJournal articleResearchpeer-review

DOI

  1. Prognostic utility of serum YKL-40 in patients with cervical cancer

    Research output: Contribution to journalJournal articleResearchpeer-review

  2. Risk factors for early death among ovarian cancer patients: a nationwide cohort study

    Research output: Contribution to journalJournal articleResearchpeer-review

  3. Robotic Surgery Is Less Physically Demanding Than Laparoscopic Surgery: Paired Cross Sectional Study

    Research output: Contribution to journalJournal articleResearchpeer-review

  4. Examining validity evidence for a simulation-based assessment tool for basic robotic surgical skills

    Research output: Contribution to journalJournal articleResearchpeer-review

  5. International Study of Primary Mucinous Ovarian Carcinomas Managed at Tertiary Medical Centers

    Research output: Contribution to journalJournal articleResearchpeer-review

  • OVHIPEC-2 Steering Committee and the Dutch OVHIPEC group
View graph of relations

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 ≤2.5 mm) primary cytoreduction, patients are randomly allocated (1:1) to receive HIPEC or no HIPEC. All patients will receive six courses of platinum-paclitaxel chemotherapy, and maintenance PARP-inhibitor or bevacizumab according to current guidelines.

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.

TRIAL REGISTRATION: ClinicalTrials.gov:NCT03772028.

Original languageEnglish
JournalInternational journal of gynecological cancer : official journal of the International Gynecological Cancer Society
Volume30
Issue number6
Pages (from-to)888-892
Number of pages5
ISSN1048-891X
DOIs
Publication statusPublished - Jun 2020

ID: 61425903