Study Comparing Tumor Debulking Surgery Versus Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer
DESKTOPIII
A Randomized Multicenter Study to Compare the Efficacy of Additional Tumor Debulking Surgery vs Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer
1 other identifier
interventional
408
12 countries
86
Brief Summary
It is still not clear whether a positive AGO-score just selects patients with less aggressive biologic tumor behavior who as well would have had a positive outcome by chemotherapy only, or , if it is a score selecting patients who really benefit from surgery. Nevertheless, the AGO-score was confirmed to select patients with a less than 30% risk of ending with residual tumor after surgery for recurrent disease. This could avoid including patients into the present surgical protocol who could not benefit from an operationThe goal of this third DESKTOP study is to evaluate in a prospectively randomized multicentre setting, whether maximum effort of cytoreductive surgery followed by platinum based combination chemotherapy can improve overall survival as compared to platinum based combination chemotherapy alone in AGO-score positive patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2010
Longer than P75 for not_applicable
86 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 16, 2010
CompletedFirst Posted
Study publicly available on registry
July 21, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedJanuary 25, 2022
December 1, 2021
9.6 years
July 16, 2010
January 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
in patients with platinum-sensitive recurrent ovarian cancer with a positive AGO Score
Approximately 36 months after last patient randomized and observation of 244 events
Secondary Outcomes (7)
Progression free survival
Progression free survival is defined as interval between date of randomization and 2nd relapse/progression or death (whatever occurs first).
Quality of Life measures with EORTC QLQ-C30 Global Health Status (GHS)
Baseline, 6, and 12 months after randomization
Quality of Life measures with EORTC QLQ-C30 Symptom Scale Insomnia
Baseline, 6, and 12 months after randomization
Quality of Life measures with EORTC QLQ-C30 Symptom Scale Constipation
Baseline, 6, and 12 months after randomization
Quality of Life measures with FACT-G total score
Baseline, 6, and 12 months after randomization
- +2 more secondary outcomes
Study Arms (2)
Control Arm - Chemotherapy only
NO INTERVENTIONChemotherapy for platinum-sensitive Ovarian Cancer can be selected on investigators choice
Procedure/Surgery
EXPERIMENTALMaximum effort cytoreductive surgery
Interventions
Surgery for Patients with platinum-sensitive recurrent ovarian cancer with a positive AGO-score predictive for complete tumor resection
Eligibility Criteria
You may qualify if:
- Patients with first recurrence of platinum sensitive, invasive epithelial ovarian-, fallopian tube- or primary peritoneal cancer of any initial stage.
- 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:
- Performance status ECOG 0
- 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.
You may not qualify if:
- Patients with non-epithelial tumors as well as borderline tumors.
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AGO Study Grouplead
- ARCAGY/ GINECO GROUPcollaborator
- Grupo Español de Investigación en Cáncer de Ovariocollaborator
- Cancer Research UKcollaborator
- Shanghai Gynecologic Oncology Groupcollaborator
Study Sites (86)
Medizinische Universität Graz, Universitätsklinik für Frauenheilkunde Graz, Abteilung Gynäkologie u. Geburtshilfe
Graz, 8036, Austria
Universitätsklinikum Innsbruck, Univ. Klinik für Gynäkologie und Geburtshilfe
Innsbruck, 6020, Austria
Medizinische Universität Wien,Universitätsklinik für Frauenheilkunde
Vienna, 1090, Austria
Wilhelminenspital der Stadt Wien, Gynäkologisch und Geburtshilfliche Abteilung
Vienna, 1160, Austria
UZ Leuven
Leuven, Belgium
Zhejiang Cancer Hospital, Gynecology Oncology
Hangzhou, 310022, China
Fudan University Cancer Hospital, Gynecologic Oncology
Shanghai, 200032, China
Fudan University Zhongshan Hospital, Obstetrics and Gynecology
Shanghai, 200032, China
Suzhou Municipal Hospital, Gynecologic and Obstetrics
Suzhou, 215002, China
Aalborg Hospital
Aalborg, 9000, Denmark
Aarhus University Hospital,Oncology
Aarhus, 8000, Denmark
Ringshospitalet Copenhagen University Hospital; Oncology
Copenhagen, 2100, Denmark
Herlev Hospital
Herlev, 2730, Denmark
Odense University Hospital, Gynaecology and Obstetrics
Odense, 5000, Denmark
Institut Bergonié, Gynecology
Bordeaux, 33076, France
Centre Francois Baclesse
Caen, 14000, France
Centre Jean Perrin
Clermont-Ferrand, 63000, France
Centre Antoine Lacassagne
Nice, Cedex 02 06189, France
Hôpital Européen Georges Pompidou
Paris, Cedex 15 75015, France
Hôpital Tenon
Paris, Cedex 20 75020, France
Insitut Jean Godinot, Service Rubis - Oncologie Médicale
Reims, 51056, France
Centre Eugène Marquis
Rennes, 35042, France
Centre Hospitalier Universitaire Charles-Nicolle
Rouen, 76000, France
Centre Henri Becquerel
Rouen, 76038, France
Centre René Gauducheau
Saint-Herblain, 44805, France
Centre Claudius Regaud
Toulouse, 31052, France
Hochtaunus-Kliniken gGmbH, Frauenklinik
Bad Homburg, 61348, Germany
Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Klinik für Frauenheilkunde
Berlin, 13353, Germany
Universitätsklinikum Carl Gustav Carus, Klinik für Frauenheilkunde u. Geburtshilfe
Dresden, 01307, Germany
Evangelisches Krankenhaus, Frauenklinik
Düsseldorf, 40217, Germany
Kaiserswerther-Diakonie, Florence-Nightingale Krankenhaus, Gynäkologie
Düsseldorf, 40489, Germany
Kliniken Essen Mitte, Evang. Huyssens-Stiftung, Gynäkologische Onkologie
Essen, 45136, Germany
Klinikum der JWG Universität Frankfurt, Klinik für Gynäkologie und Geburtshilfe
Frankfurt am Main, 60591, Germany
Universitätsklinikum Freiburg, Frauenklinik
Freiburg im Breisgau, 79106, Germany
Klinikum Fürth, Frauenklinik Nathanstift
Fürth, 90766, Germany
Georg-August-Universität Göttingen, Universitäts-Frauenklinik
Göttingen, 37075, Germany
Gynecologic Clinic of the Ernst-Moritz-Arndt-University
Greifswald, 17487, Germany
Medizinische Hochschule, Klinik für Frauenheilkunde u. Geburtshilfe
Hanover, 30625, Germany
Klinikum Kempten, Klinik für Frauenheilkunde und Geburtshilfe
Kempten, 87439, Germany
Universitätsklinikum Schleswig-Holstein Campus Kiel, Klinik f. Gynäkologie u. Geburtshilfe
Kiel, 24105, Germany
Klinikum Konstanz, Frauenklinik
Konstanz, 78464, Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Klinik für Frauenheilkunde und Geburtshilfe
Lübeck, 23538, Germany
Universitätsklinikum Mainz, Frauenklinik
Mainz, 55131, Germany
Klinikum Dritter Orden, Gynäkologie und Geburtshilfe
München, 80658, Germany
Klinikum der Universität München-Großhadern, Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
München, 81377, Germany
Oberschwaben Klinik, Krankenhaus St. Elisabeth, Frauenklinik
Ravensburg, 88212, Germany
Caritas-Krankenhaus St. Josef, Klinik für Frauenheilkunde und Geburtshilfe d. Universität Regensburg
Regensburg, 93053, Germany
Leopoldina-Krankenhaus der Stadt Schweinfurt GmbH, Frauenklinik
Schweinfurt, 97422, Germany
Universitätsklinikum, Universitätsfrauenklinik
Ulm, 89075, Germany
Ammerland-Klinik GmbH, Frauenklinik
Westerstede, 26655, Germany
HSK, Dr. Horst Schmidt Klinik GmbH, Klinik für Gynäkologie u. Gynäkologische Onkologie
Wiesbaden, 65199, Germany
Centro di Riferimento Oncologico,Struttura Operativa complessa Chirurgia Oncologica Ginecologica
Aviano, 33081, Italy
Fondazione IRCCS Istituto Nazionale Tumori di Milano
Milan, 20133, Italy
Istituto Europeo di Oncologia, Divisione di Ginecologia
Milan, 20141, Italy
Istituto Nazionale Tumori di Napoli, Gynecologic Oncology
Naples, 80100, Italy
Norwegian Radium Hospital, Oslo University Hospital, Gynecologic Oncology
Oslo, 0310, Norway
Seoul National University Hospital, Department of Obstetrics and Gynecology
Seoul, 110-744, South Korea
ICO Badalona - H. U. Germans Trias i Pujol
Badalona, 08916, Spain
Hospital de la Santa Creu i Sant Pau, Oncology
Barcelona, 08025, Spain
Hospital Clinic Barcelona, Oncology
Barcelona, 08036, Spain
ICO-Hospital Universitari de Girona Dr. Josep Trueta, Servicio de Oncologia de Girona
Girona, 17007, Spain
Avinguda Granvia de l'Hospitalet de Llobregat, Hospital de Bellvitge, Gynaecology
L'Hospitalet de Llobregat, 08907, Spain
Hospital Son Llàtzer, Oncology
Palma de Mallorca, 07198, Spain
Hospital de Navarra, Oncology
Pamplona, 31008, Spain
Fundación Instituto Valenciano de Oncologia
Valencia, 46009, Spain
Hospital Universitari i Politècnic la Fe, Oncology
Valencia, 46026, Spain
Linköping University Hospital, Department of Obstetrics and Gynecology
Linköping, 58185, Sweden
Karolinska University Hospital, Oncology
Stockholm, 17176, Sweden
Birmingham City Hospital, Cancer Research Team
Birmingham, B18 7QH, United Kingdom
Cambridge University Hospitals NHS FT - Addenbrookes Hospital, Gynaecological Oncology
Cambridge, CB2 2QQ, United Kingdom
Queen Elizabeth Hospital Gateshead, Northern gynaecological oncology centre
Gateshead, NE9 6SX, United Kingdom
Royal Surrey Country Hospital,St Lukes Cancer Centre
Guildford, GU2 7XX, United Kingdom
Lincoln County Hospital, Oncology
Lincoln, LN2 5QY, United Kingdom
St Bartholomew´s Hospital and Queen´s Hospital,Gynaecological Cancer Centre
London, C14 7BE, United Kingdom
University College London Hospital, Cancer clinical trails unit
London, NW1 2 PG, United Kingdom
Royal Marsden NHS Foundation Trust, Gynae research, Mulberry House
London, SW3 6JJ, United Kingdom
Imperial College Healthcare NHS Trust Hammersmith Hospital, Medical Oncology
London, W12 0HS, United Kingdom
Central Manchester Foundation NHS Trust, St Mary´s Hospital, Gynaecology
Manchester, M13 9W, United Kingdom
Queen Elizabeth the Queen Mother Hospital,East Kent Gynaeoncology Centre
Margate, CT9 4AN, United Kingdom
Northampton General Hospital, Gynaecological Oncology
Northampton, NN1 5 BD, United Kingdom
East and North Hertfordhire NHS Trust,Mount Vernon Hospital,Medical Oncology
Northwood, HA6 2RN, United Kingdom
Norfolk & Norwich University Hospital,Obstetrics & Gynaecology
Norwich, NR4 7UY, United Kingdom
Nottingham University Hospital, City Campus, Oncology
Nottingham, NG7 2UH, United Kingdom
Royal Hallamshire Hospital & Weston Park Hospital, Cancer Clinical Trials Centre
Sheffield, S10 2SJ, United Kingdom
Princess Anne Hospital, gynaecology
Southampton, SO16 5YA, United Kingdom
New Cross Hospital,Oncology/Gynaecology
Wolverhampton, WV10 OQP, United Kingdom
Related Publications (2)
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.
PMID: 34874631RESULTBommert 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.
PMID: 29743148DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philipp Harter, MD
AGO Study Group
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2010
First Posted
July 21, 2010
Study Start
July 1, 2010
Primary Completion
January 17, 2020
Study Completion
December 31, 2020
Last Updated
January 25, 2022
Record last verified: 2021-12