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Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

NCT03772028RecruitingPHASE3INTERVENTIONAL

Summary

stage III epithelial ovarian cancer randomizing between primary cytoreductive surgery with or without hyperthermic intraperitoneal chemotherapy

Key Facts

Lead Sponsor

The Netherlands Cancer Institute

Enrollment

538

Start Date

2020-01-01

Completion Date

2025-04-01

Study Type

INTERVENTIONAL

Official Title

Phase III Randomized Clinical Trial for Stage III Epithelial Ovarian Cancer Randomizing Between Primary Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy

Interventions

cisplatin

Conditions

Ovarian Cancer

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

* candidate for primary CRS
* histological or cytological proven FIGO stage III primary epithelial ovarian, fallopian tube, or extra-ovarian cancer

Exclusion Criteria:

* history of previous malignancies within 5 years prior to inclusion
* FIGO stage IV disease
* complete primary cytoreduction is impossible
* prior treatment for the current malignancy

Outcome Measures

Primary Outcomes

overall survival

Time frame: 1 year after last patient last visit

Secondary Outcomes

recurrence-free survival

Time frame: 1 year after last patient last visit

adverse events

toxicity of extra treatment compared standaard treatment

Time frame: 30 days after end of treatment

cost evaluation

cost evaluation based measured by quality adjusted life year

Time frame: 1 year after lplv

Locations

City of Hope, Duarte, United States

MSKCC New York, New York, United States

Rigshospitalet Copenhagen, Copenhagen, Denmark

CHU de Besancon, Besançon, France

Institut Bergonié, Bordeaux, France

o Institut Bergonié, Bordeaux, Bordeaux, France

CHU Lille, Lille, France

Centre Leon Berard, Lyon, Lyon, France

CHU Lyon, Lyon, France

Institut du Cancer Montpellier, Montpellier, France

Institut de Cancerologie de l'Ouest, ICO Nantes), Nantes, France

Institut Curie Paris, Paris, France

CHRU Strasbourg, Strasbourg, France

Oncopole, Institute Universitaire du Cancer de Toulouse (IUCT Toulouse), Toulouse, France

Mater Misericordiae University Hospital, Dublin, Dublin, Ireland

Policlinico Sant'Orsola, Bologna, Bologna, Italy

Fondazione Policlinico A Gemelli IRCCS, Roma, Italy

Antoni van leeuwenhoek, Amsterdam, Netherlands

Amsterdam UMC, Amsterdam, Netherlands

Catharina Hospital, Eindhoven, Netherlands

Medisch Spectrum Twente, Enschede, Netherlands

UMCG, Groningen, Netherlands

Leiden University Medical Center (LUMC), Leiden, Netherlands

Maastricht UMC+, Maastricht, Netherlands

Radboud MC, Nijmegen, Netherlands

Erasmus MC, Rotterdam, Netherlands

UMCU, Utrecht, Netherlands

Alice Bjoernlund-Larsen, Uppsala, Sweden

Linked Papers

2020-03-23

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

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. 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. We hypothesize that the addition of HIPEC to primary cytoreductive surgery improves overall survival in patients with primary FIGO stage III epithelial ovarian cancer. 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. 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. The primary endpoint is overall survival. 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. The OVHIPEC-2 trial started in January 2020 and primary analyses are anticipated in 2026. ClinicalTrials.gov:NCT03772028.

Linked Investigators

Gabe S. Sonke

Simone Koole

Willemien J. van Driel