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Randomized Trial of Cytoreductive Surgery for Relapsed Ovarian Cancer
Philipp Harter1, Jalid Sehouli1, Ignace Vergote1
1From the Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte, Essen (P. Harter, A.B.), the Department of Gynecology with Center for Oncological Surgery, Charité Berlin, Berlin (J.S.), the Coordinating Center for Clinical Trials (A. Reuss) and Department of Gynecology (P. Harter), Philipps University, Marburg, the Department of Obstetrics and Gynecology, Heinrich-Heine-University, Duesseldorf (W.M.), the Department of Gynecology and Obstetrics, Hannover Medical School, Hannover (P. Hillemanns), the University Medical Center Mainz, Department of Gynecology and Obstetrics, Mainz (A.H.), and Mammazentrum Hamburg at Jerusalem Hospital, Hamburg (F.H.) - all in Germany; the Department of Gynecological Oncology, University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium (I.V.); the Department of Surgical Oncology, Institut Claudius Regaud, Institut Universitaire du Cancer, Toulouse (G.F.), the Department of Medical Oncology, Groupe Hospitalier Diaconesses Croix Saint-Simon (F.S.), and Institut Curie, Oncologie Gynécologique and Université de Paris (F.L.), Paris, the Department of Surgical Oncology, Institut Bergonié, Comprehensive Cancer Center, Bordeaux (F.G.), the Department of Surgical Oncology, Jean Perrin Cancer Center, Clermont-Ferrand (C.P.), and Institut de Cancerologie de l'Ouest, Université de Médecine, Nantes (J.-M.C.) - all in France; the Gynecologic Oncology Unit, Istituto Nazionale Tumori di Napoli, Fondazione IRCCS Pascale, Naples (S.G.), and Fondazione IRCCS Istituto Nazionale Tumori, Milan (F.R.) - both in Italy; the Gyne-Oncology Department of Gynecology (B.J.M.), Copenhagen University Hospital Rigshospitalet (M.R.M.), Copenhagen, the Department of Gynecology, Aarhus University Hospital and Aarhus University, Institute of Clinical Medicine, Faculty of Health, Aarhus (P.J.), and Aalborg University Hospital, Aalborg (B.L.) - all in Denmark; the Ovarian Cancer Program, Department of Gynecologic Oncology, Fudan University Zhongshan Hospital, Shanghai, China (R.Z.); the Department of Oncology-Pathology, Karolinska Institutet, Stockholm (E.A.-L.); the Department of Obstetrics and Gynecology, Seoul National University College of Medicine, Seoul, South Korea (J.-W.K.); University Hospital of Bellvitge, Barcelona (J.P.), and the Gynecologic Oncology Unit, La Fe University Hospital, Valencia (A.S.) - both in Spain; the Department of Gynecologic Oncology and Institute for Cancer Genetics and Informatics, Oslo University Hospital, Oslo (G.K.); the Department of Surgery and Cancer, Imperial College London (S.G.-M.), and the Department of Gynaecological Oncology, University College London Hospital (A.O.) - both in London; and the Department of Gynecology and Gynecological Oncology, Medical University of Vienna, Vienna (A. Reinthaller).
Secondary cytoreductive surgery followed by chemotherapy significantly improves overall survival in recurrent ovarian cancer patients. This approach offers a survival benefit compared to chemotherapy alone for eligible patients.
Area of Science:
- Gynecologic Oncology
- Surgical Oncology
- Clinical Trials
Background:
- Recurrent ovarian cancer treatment primarily relies on systemic therapy.
- The efficacy of secondary cytoreductive surgery in this context remains uncertain.
Purpose of the Study:
- To evaluate the impact of secondary cytoreductive surgery plus chemotherapy versus chemotherapy alone on overall survival in patients with recurrent ovarian cancer.
- To assess quality of life and identify prognostic factors for survival.
Main Methods:
- Randomized trial involving 407 patients with recurrent ovarian cancer and a platinum-free interval of ≥6 months.
- Eligibility criteria included a positive Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) score, ECOG performance status 0, minimal ascites, and complete initial resection.
- Patients were assigned to either secondary cytoreductive surgery followed by chemotherapy or chemotherapy alone.
Main Results:
- Median overall survival was 53.7 months with surgery and chemotherapy versus 46.0 months with chemotherapy alone (HR 0.75, P=0.02).
- Complete resection was achieved in 75.5% of patients in the surgery arm.
- Patients achieving complete resection had a median overall survival of 61.9 months, with benefits observed across subgroups.
Conclusions:
- Secondary cytoreductive surgery followed by chemotherapy improves overall survival in women with recurrent ovarian cancer.
- The procedure demonstrated a survival benefit without increasing perioperative mortality or negatively impacting quality of life within the first year.

