Ovarian Cancer Clinical Trial
— DESKTOPIIIOfficial title:
A Randomized Multicenter Study to Compare the Efficacy of Additional Tumor Debulking Surgery vs Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer
Verified date | December 2021 |
Source | AGO Study Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 408 |
Est. completion date | December 31, 2020 |
Est. primary completion date | January 17, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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: 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 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) |
Country | Name | City | State |
---|---|---|---|
Austria | 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 | Wien | |
Austria | Wilhelminenspital der Stadt Wien, Gynäkologisch und Geburtshilfliche Abteilung | Wien | |
Belgium | UZ Leuven | Leuven | |
China | 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 | |
Denmark | 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 | |
France | 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 Henri Becquerel | Rouen | |
France | Centre Hospitalier Universitaire Charles-Nicolle | Rouen | |
France | Centre René Gauducheau | Saint-Herblain | |
France | Centre Claudius Regaud | Toulouse | |
Germany | 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 | |
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 | Hannover | |
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 der Universität München-Großhadern, Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe | München | |
Germany | Klinikum Dritter Orden, Gynäkologie 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 | |
Italy | 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 | |
Korea, Republic of | Seoul National University Hospital, Department of Obstetrics and Gynecology | Seoul | |
Norway | Norwegian Radium Hospital, Oslo University Hospital, Gynecologic Oncology | Oslo | |
Spain | ICO Badalona - H. U. Germans Trias i Pujol | Badalona | |
Spain | Hospital Clinic Barcelona, Oncology | Barcelona | |
Spain | Hospital de la Santa Creu i Sant Pau, 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 | 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 | |
Sweden | Linköping University Hospital, Department of Obstetrics and Gynecology | Linköping | |
Sweden | Karolinska University Hospital, Oncology | Stockholm | |
United Kingdom | 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 | Imperial College Healthcare NHS Trust Hammersmith Hospital, Medical Oncology | London | |
United Kingdom | Royal Marsden NHS Foundation Trust, Gynae research, Mulberry House | London | |
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 | 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 |
Lead Sponsor | Collaborator |
---|---|
AGO Study Group | ARCAGY/ GINECO GROUP, Cancer Research UK, Grupo Español de Investigación en Cáncer de Ovario, Shanghai Gynecologic Oncology Group |
Austria, Belgium, China, Denmark, France, Germany, Italy, Korea, Republic of, Norway, Spain, Sweden, United Kingdom,
Harter P, Sehouli J, Vergote I, Ferron G, Reuss A, Meier W, Greggi S, Mosgard BJ, Selle F, Guyon F, Pomel C, Lécuru 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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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). | |
Secondary | Quality of Life measures with EORTC QLQ-C30 Global Health Status (GHS) | GHS scale-core item 29, 30; ranges 0-100 | Baseline, 6, and 12 months after randomization | |
Secondary | Quality of Life measures with EORTC QLQ-C30 Symptom Scale Insomnia | Item 11, ranges 0-100 | Baseline, 6, and 12 months after randomization | |
Secondary | Quality of Life measures with EORTC QLQ-C30 Symptom Scale Constipation | Item 16, ranges 0-100 | Baseline, 6, and 12 months after randomization | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
Withdrawn |
NCT05201001 -
APX005M in Patients With Recurrent Ovarian Cancer
|
Phase 2 | |
Completed |
NCT02963831 -
A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT06376253 -
A Phase I Study of [177Lu]Lu-EVS459 in Patients With Ovarian and Lung Cancers
|
Phase 1 | |
Recruiting |
NCT05489211 -
Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)
|
Phase 2 | |
Recruiting |
NCT03412877 -
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
|
Phase 2 | |
Active, not recruiting |
NCT03667716 -
COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.
|
Phase 1 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT05156892 -
Tamoxifen and SUBA-Itraconzole Combination Testing in Ovarian Cancer
|
Phase 1 | |
Suspended |
NCT02432378 -
Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines
|
Phase 1/Phase 2 | |
Recruiting |
NCT04533763 -
Living WELL: A Web-Based Program for Ovarian Cancer Survivors
|
N/A | |
Active, not recruiting |
NCT03371693 -
Cytoreductive Surgery(CRS) Plus Hyperthermic Intraperitoneal Chemotherapy(HIPEC) With Lobaplatin in Advanced and Recurrent Epithelial Ovarian Cancer
|
Phase 3 | |
Withdrawn |
NCT03032614 -
Combination of Carboplatin, Eribulin and Veliparib in Stage IV Cancer Patients
|
Phase 2 | |
Completed |
NCT01936363 -
Trial of Pimasertib With SAR245409 or Placebo in Ovarian Cancer
|
Phase 2 | |
Completed |
NCT02019524 -
Phase Ib Trial of Two Folate Binding Protein Peptide Vaccines (E39 and J65) in Breast and Ovarian Cancer Patients
|
Phase 1 | |
Terminated |
NCT00788125 -
Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT05059522 -
Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing
|
Phase 3 | |
Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
Terminated |
NCT04586335 -
Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors.
|
Phase 1 | |
Terminated |
NCT03146663 -
NUC-1031 in Patients With Platinum-Resistant Ovarian Cancer
|
Phase 2 |