Study Comparing Tumor Debulking Surgery Versus Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer

Not Applicable

Completed

• Conditions: Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cavity Cancer
• Interventions: Procedure: Tumor Debulking Surgery (surgery in recurrent ovarian disease)

• Registration Number: NCT01166737
• Lead Sponsor: AGO Study Group

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.

Detailed Description

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 .

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-16
• Study First Submitted QC: 2010-07-20
• Study First Posted: 2010-07-21
• Primary Completion: 2020-01-17
• Study Completion: 2020-12-31
• Status Verified: 2021-12
• Last Update Submitted: 2022-01-21
• Last Update Posted: 2022-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 408

Inclusion Criteria

Not provided

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Procedure/Surgery	Tumor Debulking Surgery (surgery in recurrent ovarian disease)	Maximum effort cytoreductive surgery

Primary Outcome Measures

Name	Time	Method
Overall survival	Approximately 36 months after last patient randomized and observation of 244 events	in patients with platinum-sensitive recurrent ovarian cancer with a positive AGO Score

Secondary Outcome Measures

Name	Time	Method
Quality of Life measures with FACT-O total score	Baseline, 6, and 12 months after randomization	Sum of FACT-G and and Ovarian Cancer subscale, ranges 0-152
Quality of Life measures with FACT-O Ovarian Cancer subscale	Baseline, 6, and 12 months after randomization	Composite of 11 items regarding specific to Ovarian Cancer patients, ranges 0-44
Quality of Life measures with EORTC QLQ-C30 Symptom Scale Insomnia	Baseline, 6, and 12 months after randomization	Item 11, ranges 0-100
Progression free survival	Progression free survival is defined as interval between date of randomization and 2nd relapse/progression or death (whatever occurs first).	patients with platinum-sensitive recurrent ovarian cancer with a positive AGO Score
Quality of Life measures with EORTC QLQ-C30 Symptom Scale Constipation	Baseline, 6, and 12 months after randomization	Item 16, ranges 0-100
Quality of Life measures with EORTC QLQ-C30 Global Health Status (GHS)	Baseline, 6, and 12 months after randomization	GHS scale-core item 29, 30; ranges 0-100
Quality of Life measures with FACT-G total score	Baseline, 6, and 12 months after randomization	Composite of 27 items regarding physical, functional, social/family and emotional well-being. from 0-108

Trial Locations

Locations (86)

Wilhelminenspital der Stadt Wien, Gynäkologisch und Geburtshilfliche Abteilung; 🇦🇹 Wien, Austria

Medizinische Universität Graz, Universitätsklinik für Frauenheilkunde Graz, Abteilung Gynäkologie u. Geburtshilfe; 🇦🇹 Graz, Austria

Hôpital Européen Georges Pompidou; 🇫🇷 Paris, France

Centre Jean Perrin; 🇫🇷 Clermont-Ferrand, France

Nottingham University Hospital, City Campus, Oncology; 🇬🇧 Nottingham, United Kingdom

Centre Eugène Marquis; 🇫🇷 Rennes, France

Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Klinik für Frauenheilkunde und Geburtshilfe; 🇩🇪 Lübeck, Germany

HSK, Dr. Horst Schmidt Klinik GmbH, Klinik für Gynäkologie u. Gynäkologische Onkologie; 🇩🇪 Wiesbaden, Germany

Centre Antoine Lacassagne; 🇫🇷 Nice, France

Centre René Gauducheau; 🇫🇷 Saint-Herblain, France

UZ Leuven; 🇧🇪 Leuven, Belgium

Centro di Riferimento Oncologico,Struttura Operativa complessa Chirurgia Oncologica Ginecologica; 🇮🇹 Aviano, Italy

Hospital Clinic Barcelona, Oncology; 🇪🇸 Barcelona, Spain

Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Klinik für Frauenheilkunde; 🇩🇪 Berlin, Germany

Gynecologic Clinic of the Ernst-Moritz-Arndt-University; 🇩🇪 Greifswald, Germany

Medizinische Hochschule, Klinik für Frauenheilkunde u. Geburtshilfe; 🇩🇪 Hannover, Germany

Birmingham City Hospital, Cancer Research Team; 🇬🇧 Birmingham, United Kingdom

Lincoln County Hospital, Oncology; 🇬🇧 Lincoln, United Kingdom

ICO Badalona - H. U. Germans Trias i Pujol; 🇪🇸 Badalona, Spain

Centre Henri Becquerel; 🇫🇷 Rouen, France

Hospital de la Santa Creu i Sant Pau, Oncology; 🇪🇸 Barcelona, Spain

Royal Hallamshire Hospital & Weston Park Hospital, Cancer Clinical Trials Centre; 🇬🇧 Sheffield, United Kingdom

Centre Hospitalier Universitaire Charles-Nicolle; 🇫🇷 Rouen, France

Caritas-Krankenhaus St. Josef, Klinik für Frauenheilkunde und Geburtshilfe d. Universität Regensburg; 🇩🇪 Regensburg, Germany

Avinguda Granvia de l'Hospitalet de Llobregat, Hospital de Bellvitge, Gynaecology; 🇪🇸 Hospitalet de Llobregat, Spain

Klinikum Kempten, Klinik für Frauenheilkunde und Geburtshilfe; 🇩🇪 Kempten, Germany

Queen Elizabeth Hospital Gateshead, Northern gynaecological oncology centre; 🇬🇧 Gateshead, United Kingdom

Insitut Jean Godinot, Service Rubis - Oncologie Médicale; 🇫🇷 Reims, France

Universitätsklinikum Schleswig-Holstein Campus Kiel, Klinik f. Gynäkologie u. Geburtshilfe; 🇩🇪 Kiel, Germany

Oberschwaben Klinik, Krankenhaus St. Elisabeth, Frauenklinik; 🇩🇪 Ravensburg, Germany

Karolinska University Hospital, Oncology; 🇸🇪 Stockholm, Sweden

Royal Marsden NHS Foundation Trust, Gynae research, Mulberry House; 🇬🇧 London, United Kingdom

Institut Bergonié, Gynecology; 🇫🇷 Bordeaux, France

Georg-August-Universität Göttingen, Universitäts-Frauenklinik; 🇩🇪 Göttingen, Germany

Klinikum Dritter Orden, Gynäkologie und Geburtshilfe; 🇩🇪 München, Germany

Cambridge University Hospitals NHS FT - Addenbrookes Hospital, Gynaecological Oncology; 🇬🇧 Cambridge, United Kingdom

Royal Surrey Country Hospital,St Lukes Cancer Centre; 🇬🇧 Guildford, United Kingdom

Centre Francois Baclesse; 🇫🇷 Caen, France

Klinikum der JWG Universität Frankfurt, Klinik für Gynäkologie und Geburtshilfe; 🇩🇪 Frankfurt am Main, Germany

Hospital Universitari i Politècnic la Fe, Oncology; 🇪🇸 Valencia, Spain

Istituto Europeo di Oncologia, Divisione di Ginecologia; 🇮🇹 Milan, Italy

ICO-Hospital Universitari de Girona Dr. Josep Trueta, Servicio de Oncologia de Girona; 🇪🇸 Girona, Spain

Evangelisches Krankenhaus, Frauenklinik; 🇩🇪 Düsseldorf, Germany

Hospital de Navarra, Oncology; 🇪🇸 Pamplona, Spain

Seoul National University Hospital, Department of Obstetrics and Gynecology; 🇰🇷 Seoul, Korea, Republic of

Kliniken Essen Mitte, Evang. Huyssens-Stiftung, Gynäkologische Onkologie; 🇩🇪 Essen, Germany

Hochtaunus-Kliniken gGmbH, Frauenklinik; 🇩🇪 Bad Homburg, Germany

New Cross Hospital,Oncology/Gynaecology; 🇬🇧 Wolverhampton, United Kingdom

Norfolk & Norwich University Hospital,Obstetrics & Gynaecology; 🇬🇧 Norwich, United Kingdom

Central Manchester Foundation NHS Trust, St Mary´s Hospital, Gynaecology; 🇬🇧 Manchester, United Kingdom

East and North Hertfordhire NHS Trust,Mount Vernon Hospital,Medical Oncology; 🇬🇧 Northwood, United Kingdom

Princess Anne Hospital, gynaecology; 🇬🇧 Southampton, United Kingdom

Suzhou Municipal Hospital, Gynecologic and Obstetrics; 🇨🇳 Suzhou, China

Universitätsklinikum Carl Gustav Carus, Klinik für Frauenheilkunde u. Geburtshilfe; 🇩🇪 Dresden, Germany

Kaiserswerther-Diakonie, Florence-Nightingale Krankenhaus, Gynäkologie; 🇩🇪 Düsseldorf, Germany

Ammerland-Klinik GmbH, Frauenklinik; 🇩🇪 Westerstede, Germany

Fundación Instituto Valenciano de Oncologia; 🇪🇸 Valencia, Spain

Queen Elizabeth the Queen Mother Hospital,East Kent Gynaeoncology Centre; 🇬🇧 Margate, United Kingdom

Imperial College Healthcare NHS Trust Hammersmith Hospital, Medical Oncology; 🇬🇧 London, United Kingdom

Fudan University Zhongshan Hospital, Obstetrics and Gynecology; 🇨🇳 Shanghai, China

Aalborg Hospital; 🇩🇰 Aalborg, Denmark

Aarhus University Hospital,Oncology; 🇩🇰 Aarhus, Denmark

Zhejiang Cancer Hospital, Gynecology Oncology; 🇨🇳 Hangzhou, China

Fudan University Cancer Hospital, Gynecologic Oncology; 🇨🇳 Shanghai, China

Ringshospitalet Copenhagen University Hospital; Oncology; 🇩🇰 Copenhagen, Denmark

Herlev Hospital; 🇩🇰 Herlev, Denmark

Odense University Hospital, Gynaecology and Obstetrics; 🇩🇰 Odense, Denmark

Medizinische Universität Wien,Universitätsklinik für Frauenheilkunde; 🇦🇹 Wien, Austria

Universitätsklinikum Innsbruck, Univ. Klinik für Gynäkologie und Geburtshilfe; 🇦🇹 Innsbruck, Austria

Norwegian Radium Hospital, Oslo University Hospital, Gynecologic Oncology; 🇳🇴 Oslo, Norway

Fondazione IRCCS Istituto Nazionale Tumori di Milano; 🇮🇹 Milan, Italy

Istituto Nazionale Tumori di Napoli, Gynecologic Oncology; 🇮🇹 Naples, Italy

Linköping University Hospital, Department of Obstetrics and Gynecology; 🇸🇪 Linköping, Sweden

University College London Hospital, Cancer clinical trails unit; 🇬🇧 London, United Kingdom

Northampton General Hospital, Gynaecological Oncology; 🇬🇧 Northampton, United Kingdom

Hôpital Tenon; 🇫🇷 Paris, France

Centre Claudius Regaud; 🇫🇷 Toulouse, France

Hospital Son Llàtzer, Oncology; 🇪🇸 Palma de Mallorca, Spain

Universitätsklinikum Freiburg, Frauenklinik; 🇩🇪 Freiburg, Germany

Klinikum Fürth, Frauenklinik Nathanstift; 🇩🇪 Fürth, Germany

Klinikum Konstanz, Frauenklinik; 🇩🇪 Konstanz, Germany

Universitätsklinikum Mainz, Frauenklinik; 🇩🇪 Mainz, Germany

Klinikum der Universität München-Großhadern, Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe; 🇩🇪 München, Germany

Universitätsklinikum, Universitätsfrauenklinik; 🇩🇪 Ulm, Germany

Leopoldina-Krankenhaus der Stadt Schweinfurt GmbH, Frauenklinik; 🇩🇪 Schweinfurt, Germany

St Bartholomew´s Hospital and Queen´s Hospital,Gynaecological Cancer Centre; 🇬🇧 London, United Kingdom