Study Comparing Tumor Debulking Surgery Versus Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer
NCT ID: NCT01166737
Last Updated: 2022-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
408 participants
INTERVENTIONAL
2010-07-31
2020-12-31
Brief Summary
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Detailed Description
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Study centres are selected due to their surgical experience in ovarian cancer and/or participation in prior surgical trials in this field. Patients who matched eligibility criteria were allocated randomly 1:1 prospectively to cytoreductive surgery followed by platinum based combination chemotherapy or to platinum based combination chemotherapy alone .
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
OTHER
NONE
Study Groups
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Control Arm - Chemotherapy only
Chemotherapy for platinum-sensitive Ovarian Cancer can be selected on investigators choice
No interventions assigned to this group
Procedure/Surgery
Maximum effort cytoreductive surgery
Tumor Debulking Surgery (surgery in recurrent ovarian disease)
Surgery for Patients with platinum-sensitive recurrent ovarian cancer with a positive AGO-score predictive for complete tumor resection
Interventions
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Tumor Debulking Surgery (surgery in recurrent ovarian disease)
Surgery for Patients with platinum-sensitive recurrent ovarian cancer with a positive AGO-score predictive for complete tumor resection
Eligibility Criteria
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Inclusion Criteria
* Progression-free interval of at least 6 months after end of last platinum-containing therapy, or recurrence within 6 months or later after primary surgery if the patient has not received prior chemotherapy in patients with FIGO I. Non cytostatic maintenance therapy not containing platinum will not be considered for this calculation.
* A positive AGO-score. Obligatory requirements for a positive AGO recurrence score in platinum-sensitive disease:
1. Performance status ECOG 0
2. No residual tumor after primary surgery (if unknown, alternatively primary FIGO stage I/II). If report from 1st surgery is not available contact study chairman who will decide whether inclusion is possible or not.
3. Absence of ascites (cut off \< 500 ml: radiological or ultrasound estimation)
* Complete resection of the tumor by median laparotomy seems possible
* Patients who have given their signed and written informed consent and their consent to data transmission and -processing.
Exclusion Criteria
* Patients without recurrence who are scheduled for diagnostic/second-look surgery or debulking surgery after completion of chemotherapy
* More than one prior chemotherapy
* Patients with second, third, or later recurrence
* Patients with second malignancies who have been treated by laparotomy, as well as other neoplasms, if the treatment might interfere with the treatment of relapsed ovarian cancer or if major impact on prognosis is expected.
* Patients with so-called platinum-refractory tumor, i.e. progression during chemotherapy or recurrence within 6 months after end of former first platinum-containing therapy
* Only palliative surgery planned
* Radiological signs suggesting metastases not accessible to surgical removal (i.e. complete resection is deemed impossible)
* Any concomitant disease not allowing surgery and/or chemotherapy
* Any medical history indicating excessive peri-operative risk
* Any current medication inducing considerable surgical risk (e.g. bleeding: due to oral anticoagulating agents, bevacizumab)
18 Years
FEMALE
No
Sponsors
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ARCAGY/ GINECO GROUP
OTHER
Grupo Español de Investigación en Cáncer de Ovario
OTHER
Cancer Research UK
OTHER
Shanghai Gynecologic Oncology Group
OTHER_GOV
AGO Study Group
OTHER
Responsible Party
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Principal Investigators
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Philipp Harter, MD
Role: PRINCIPAL_INVESTIGATOR
AGO Study Group
Locations
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Medizinische Universität Graz, Universitätsklinik für Frauenheilkunde Graz, Abteilung Gynäkologie u. Geburtshilfe
Graz, , Austria
Universitätsklinikum Innsbruck, Univ. Klinik für Gynäkologie und Geburtshilfe
Innsbruck, , Austria
Medizinische Universität Wien,Universitätsklinik für Frauenheilkunde
Vienna, , Austria
Wilhelminenspital der Stadt Wien, Gynäkologisch und Geburtshilfliche Abteilung
Vienna, , Austria
UZ Leuven
Leuven, , Belgium
Zhejiang Cancer Hospital, Gynecology Oncology
Hangzhou, , China
Fudan University Cancer Hospital, Gynecologic Oncology
Shanghai, , China
Fudan University Zhongshan Hospital, Obstetrics and Gynecology
Shanghai, , China
Suzhou Municipal Hospital, Gynecologic and Obstetrics
Suzhou, , China
Aalborg Hospital
Aalborg, , Denmark
Aarhus University Hospital,Oncology
Aarhus, , Denmark
Ringshospitalet Copenhagen University Hospital; Oncology
Copenhagen, , Denmark
Herlev Hospital
Herlev, , Denmark
Odense University Hospital, Gynaecology and Obstetrics
Odense, , Denmark
Institut Bergonié, Gynecology
Bordeaux, , France
Centre Francois Baclesse
Caen, , France
Centre Jean Perrin
Clermont-Ferrand, , France
Centre Antoine Lacassagne
Nice, , France
Hôpital Européen Georges Pompidou
Paris, , France
Hôpital Tenon
Paris, , France
Insitut Jean Godinot, Service Rubis - Oncologie Médicale
Reims, , France
Centre Eugène Marquis
Rennes, , France
Centre Hospitalier Universitaire Charles-Nicolle
Rouen, , France
Centre Henri Becquerel
Rouen, , France
Centre René Gauducheau
Saint-Herblain, , France
Centre Claudius Regaud
Toulouse, , France
Hochtaunus-Kliniken gGmbH, Frauenklinik
Bad Homburg, , Germany
Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Klinik für Frauenheilkunde
Berlin, , Germany
Universitätsklinikum Carl Gustav Carus, Klinik für Frauenheilkunde u. Geburtshilfe
Dresden, , Germany
Evangelisches Krankenhaus, Frauenklinik
Düsseldorf, , Germany
Kaiserswerther-Diakonie, Florence-Nightingale Krankenhaus, Gynäkologie
Düsseldorf, , Germany
Kliniken Essen Mitte, Evang. Huyssens-Stiftung, Gynäkologische Onkologie
Essen, , Germany
Klinikum der JWG Universität Frankfurt, Klinik für Gynäkologie und Geburtshilfe
Frankfurt am Main, , Germany
Universitätsklinikum Freiburg, Frauenklinik
Freiburg im Breisgau, , Germany
Klinikum Fürth, Frauenklinik Nathanstift
Fürth, , Germany
Georg-August-Universität Göttingen, Universitäts-Frauenklinik
Göttingen, , Germany
Gynecologic Clinic of the Ernst-Moritz-Arndt-University
Greifswald, , Germany
Medizinische Hochschule, Klinik für Frauenheilkunde u. Geburtshilfe
Hanover, , Germany
Klinikum Kempten, Klinik für Frauenheilkunde und Geburtshilfe
Kempten, , Germany
Universitätsklinikum Schleswig-Holstein Campus Kiel, Klinik f. Gynäkologie u. Geburtshilfe
Kiel, , Germany
Klinikum Konstanz, Frauenklinik
Konstanz, , Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Klinik für Frauenheilkunde und Geburtshilfe
Lübeck, , Germany
Universitätsklinikum Mainz, Frauenklinik
Mainz, , Germany
Klinikum Dritter Orden, Gynäkologie und Geburtshilfe
München, , Germany
Klinikum der Universität München-Großhadern, Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
München, , Germany
Oberschwaben Klinik, Krankenhaus St. Elisabeth, Frauenklinik
Ravensburg, , Germany
Caritas-Krankenhaus St. Josef, Klinik für Frauenheilkunde und Geburtshilfe d. Universität Regensburg
Regensburg, , Germany
Leopoldina-Krankenhaus der Stadt Schweinfurt GmbH, Frauenklinik
Schweinfurt, , Germany
Universitätsklinikum, Universitätsfrauenklinik
Ulm, , Germany
Ammerland-Klinik GmbH, Frauenklinik
Westerstede, , Germany
HSK, Dr. Horst Schmidt Klinik GmbH, Klinik für Gynäkologie u. Gynäkologische Onkologie
Wiesbaden, , Germany
Centro di Riferimento Oncologico,Struttura Operativa complessa Chirurgia Oncologica Ginecologica
Aviano, , Italy
Fondazione IRCCS Istituto Nazionale Tumori di Milano
Milan, , Italy
Istituto Europeo di Oncologia, Divisione di Ginecologia
Milan, , Italy
Istituto Nazionale Tumori di Napoli, Gynecologic Oncology
Naples, , Italy
Norwegian Radium Hospital, Oslo University Hospital, Gynecologic Oncology
Oslo, , Norway
Seoul National University Hospital, Department of Obstetrics and Gynecology
Seoul, , South Korea
ICO Badalona - H. U. Germans Trias i Pujol
Badalona, , Spain
Hospital de la Santa Creu i Sant Pau, Oncology
Barcelona, , Spain
Hospital Clinic Barcelona, Oncology
Barcelona, , Spain
ICO-Hospital Universitari de Girona Dr. Josep Trueta, Servicio de Oncologia de Girona
Girona, , Spain
Avinguda Granvia de l'Hospitalet de Llobregat, Hospital de Bellvitge, Gynaecology
L'Hospitalet de Llobregat, , Spain
Hospital Son Llàtzer, Oncology
Palma de Mallorca, , Spain
Hospital de Navarra, Oncology
Pamplona, , Spain
Fundación Instituto Valenciano de Oncologia
Valencia, , Spain
Hospital Universitari i Politècnic la Fe, Oncology
Valencia, , Spain
Linköping University Hospital, Department of Obstetrics and Gynecology
Linköping, , Sweden
Karolinska University Hospital, Oncology
Stockholm, , Sweden
Birmingham City Hospital, Cancer Research Team
Birmingham, , United Kingdom
Cambridge University Hospitals NHS FT - Addenbrookes Hospital, Gynaecological Oncology
Cambridge, , United Kingdom
Queen Elizabeth Hospital Gateshead, Northern gynaecological oncology centre
Gateshead, , United Kingdom
Royal Surrey Country Hospital,St Lukes Cancer Centre
Guildford, , United Kingdom
Lincoln County Hospital, Oncology
Lincoln, , United Kingdom
St Bartholomew´s Hospital and Queen´s Hospital,Gynaecological Cancer Centre
London, , United Kingdom
University College London Hospital, Cancer clinical trails unit
London, , United Kingdom
Royal Marsden NHS Foundation Trust, Gynae research, Mulberry House
London, , United Kingdom
Imperial College Healthcare NHS Trust Hammersmith Hospital, Medical Oncology
London, , United Kingdom
Central Manchester Foundation NHS Trust, St Mary´s Hospital, Gynaecology
Manchester, , United Kingdom
Queen Elizabeth the Queen Mother Hospital,East Kent Gynaeoncology Centre
Margate, , United Kingdom
Northampton General Hospital, Gynaecological Oncology
Northampton, , United Kingdom
East and North Hertfordhire NHS Trust,Mount Vernon Hospital,Medical Oncology
Northwood, , United Kingdom
Norfolk & Norwich University Hospital,Obstetrics & Gynaecology
Norwich, , United Kingdom
Nottingham University Hospital, City Campus, Oncology
Nottingham, , United Kingdom
Royal Hallamshire Hospital & Weston Park Hospital, Cancer Clinical Trials Centre
Sheffield, , United Kingdom
Princess Anne Hospital, gynaecology
Southampton, , United Kingdom
New Cross Hospital,Oncology/Gynaecology
Wolverhampton, , United Kingdom
Countries
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References
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Harter P, Sehouli J, Vergote I, Ferron G, Reuss A, Meier W, Greggi S, Mosgaard BJ, Selle F, Guyon F, Pomel C, Lecuru F, Zang R, Avall-Lundqvist E, Kim JW, Ponce J, Raspagliesi F, Kristensen G, Classe JM, Hillemanns P, Jensen P, Hasenburg A, Ghaem-Maghami S, Mirza MR, Lund B, Reinthaller A, Santaballa A, Olaitan A, Hilpert F, du Bois A; DESKTOP III Investigators. Randomized Trial of Cytoreductive Surgery for Relapsed Ovarian Cancer. N Engl J Med. 2021 Dec 2;385(23):2123-2131. doi: 10.1056/NEJMoa2103294.
Bommert M, Harter P, Heitz F, du Bois A. When should Surgery be used for Recurrent Ovarian Carcinoma? Clin Oncol (R Coll Radiol). 2018 Aug;30(8):493-497. doi: 10.1016/j.clon.2018.04.006. Epub 2018 May 7.
Other Identifiers
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AGO-OVAR OP.4 DESKTOP III
Identifier Type: -
Identifier Source: org_study_id
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