When is the best time for ovarian cancer surgery?
NCT ID NCT02828618
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at the best time to perform surgery for advanced ovarian cancer. It compares having surgery right away versus after a few rounds of chemotherapy. The goal is to see which approach helps people live longer. About 800 women with stage IIIB-IV ovarian cancer are taking part.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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797 people
The number who actually took part.
- Start date
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Jul 2016
- Expected to finish
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Dec 2025
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * suspected or histologically confirmed, newly diagnosed invasive epithelial ovarian cancer FIGO stage IIIB-IV (IV only if resectable metastasis) * Females aged ≥ 18 years * Patients who have given their written informed consent * Good performance status (ECOG 0/1) * Good ASA score (1/2) * Preoperative CA 125/CEA ratio ≥ 25 (if CA-125 is elevated)\* * If \<25 and/or biopsy with non-serous, non-endometroid histology, esophago-gastro-duodenoscopy (EGD) and colonoscopy mandatory to exclude gastrointestinal primary cancer * Assessment of an experienced surgeon, that based on all available information, the patient can undergo the procedure and the tumor can potentially be completely resected * Adequate bone marrow function: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L. This ANC cannot have been induced or supported by granulocyte colony stimulating factors. * Platelet count ≥ 100 x 109/L. * Renal function: Serum-Creatinine ≤ 1.5 x institutional upper limit normal (ULN). * Hepatic function: * Bilirubin ≤ 1.5 x ULN. * SGOT ≤ 3 x ULN * Alkaline phosphatase ≤ 2.5 x ULN. * Neurologic function: Neuropathy (sensory and motor) less than or equal to CTCAE Grade 1. Exclusion Criteria: * Non epithelial ovarian malignancies and borderline tumors * Secondary invasive neoplasms in the last 5 years (except synchronal endometrial carcinoma FIGO IA G1/2, non melanoma skin cancer, breast cancer T1 N0 M0 G1/2) or with any signs of relapse or activity. * Recurrent ovarian cancer * Prior chemotherapy for ovarian cancer or abdominal/pelvic radiotherapy * Unresectable parenchymal lung metastasis, liver metastasis or bulky lymph-nodes in the mediastinum in CT chest and abdomen/pelvis * Clinical relevant dysfunctions of blood clotting (including drug induced) * Any significant medical reasons, age or performance status that will not allow to perform the study procedures (estimation of investigator) * Pregnancy * Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent * Any reasons interfering with regular follow-up
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum, Klinik für Gynäkologie
Berlin, 13353, Germany
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European Institute of Oncology; Gynecologic Cancer Surgery
Milan, Italy
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Fondazione IRCCS Istituto Nazionale Tumori - Milan
Milan, Italy
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Hôpital Européen Georges Pompidou (HEGP)
Paris, France
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Imperial College London, Hammersmith Hospital, Surgery&Cancer
London, W12 OHS, United Kingdom
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Institut Bergonié
Bordeaux, France
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Institute Gustave Roussy
Villejuif, 94805, France
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Istituto Nazionale per lo Studio e la Cura dei Tumori di Napoli
Naples, Italy
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Kaiserswerther Diakonie; Florence-Nightingale-Hospital
Düsseldorf, Germany
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Karolinska University Hospital
Solna, 17176, Sweden
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Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe, Klinikum der Universität München
München, 81377, Germany
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Kliniken Essen-Mitte, Evang. Huyssens-Stiftung, Klinik für Gynäkologie und gyn. Onkologie
Essen, 45136, Germany
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Klinikum rechts der Isar, Frauen- und Poliklinik
München, 81675, Germany
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Medical University of Vienna
Vienna, A-1090, Austria
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Skane University Hospital
Lund, 22185, Sweden
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University Hospital, Rigshospitalet
Copenhagen, 2100, Denmark
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Universitätsklinikum Carl Gustav Carus Dresden, Klinik & Poliklinik f. Frauenheilkunde & Geburtshilfe
Dresden, 01307, Germany
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Universitätsklinikum Hamburg-Eppendorf, Klinik und Poliklinik für Gynäkologie
Hamburg, 20246, Germany
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Universitätsklinikum Tübingen
Tübingen, Germany
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Other studies related to the condition(s) this trial covers.
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