Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| ARCAGY/ GINECO GROUP | OTHER |
| Grupo Español de Investigación en Cáncer de Ovario | OTHER |
| Cancer Research UK | OTHER |
| Shanghai Gynecologic Oncology Group |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
A predictive score identifying patients who might achieve a complete resection is deemed necessary to select the right patients for a prospective trial on cytoreductive surgery in relapsed ovarian cancer.
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 .
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm - Chemotherapy only | No Intervention | Chemotherapy for platinum-sensitive Ovarian Cancer can be selected on investigators choice | |
| Procedure/Surgery | Experimental | Maximum effort cytoreductive surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tumor Debulking Surgery (surgery in recurrent ovarian disease) | Procedure | Surgery for Patients with platinum-sensitive recurrent ovarian cancer with a positive AGO-score predictive for complete tumor resection |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | patients with platinum-sensitive recurrent ovarian cancer with a positive AGO Score | 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) |
Not provided
Inclusion criteria:
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:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Philipp Harter, MD | AGO Study Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Universität Graz, Universitätsklinik für Frauenheilkunde Graz, Abteilung Gynäkologie u. Geburtshilfe | Graz | 8036 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34874631 | Result | 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. | |
| 29743148 |
Not provided
Not provided
Not provided
| OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
GHS scale-core item 29, 30; ranges 0-100 |
| Baseline, 6, and 12 months after randomization |
| Quality of Life measures with EORTC QLQ-C30 Symptom Scale Insomnia | Item 11, ranges 0-100 | Baseline, 6, and 12 months after randomization |
| Quality of Life measures with EORTC QLQ-C30 Symptom Scale Constipation | Item 16, ranges 0-100 | Baseline, 6, and 12 months after randomization |
| Quality of Life measures with FACT-G total score | Composite of 27 items regarding physical, functional, social/family and emotional well-being. from 0-108 | Baseline, 6, and 12 months after randomization |
| Quality of Life measures with FACT-O Ovarian Cancer subscale | Composite of 11 items regarding specific to Ovarian Cancer patients, ranges 0-44 | Baseline, 6, and 12 months after randomization |
| Quality of Life measures with FACT-O total score | Sum of FACT-G and and Ovarian Cancer subscale, ranges 0-152 | Baseline, 6, and 12 months after randomization |
| 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 |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| D010051 | Ovarian Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided