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

January 21, 2022 updated by: AGO Study Group

A Randomized Multicenter Study to Compare the Efficacy of Additional Tumor Debulking Surgery vs Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

408

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Medizinische Universität Graz, Universitätsklinik für Frauenheilkunde Graz, Abteilung Gynäkologie u. Geburtshilfe
      • Innsbruck, Austria, 6020
        • Universitätsklinikum Innsbruck, Univ. Klinik für Gynäkologie und Geburtshilfe
      • Wien, Austria, 1090
        • Medizinische Universität Wien,Universitätsklinik für Frauenheilkunde
      • Wien, Austria, 1160
        • Wilhelminenspital der Stadt Wien, Gynäkologisch und Geburtshilfliche Abteilung
  • Belgium
      • Leuven, Belgium
        • UZ Leuven
  • China
      • Hangzhou, China, 310022
        • Zhejiang Cancer Hospital, Gynecology Oncology
      • Shanghai, China, 200032
        • Fudan University Cancer Hospital, Gynecologic Oncology
      • Shanghai, China, 200032
        • Fudan University Zhongshan Hospital, Obstetrics and Gynecology
      • Suzhou, China, 215002
        • Suzhou Municipal Hospital, Gynecologic and Obstetrics
  • Denmark
      • Aalborg, Denmark, 9000
        • Aalborg Hospital
      • Aarhus, Denmark, 8000
        • Aarhus University Hospital,Oncology
      • Copenhagen, Denmark, 2100
        • Ringshospitalet Copenhagen University Hospital; Oncology
      • Herlev, Denmark, 2730
        • Herlev Hospital
      • Odense, Denmark, 5000
        • Odense University Hospital, Gynaecology and Obstetrics
  • France
      • Bordeaux, France, 33076
        • Institut Bergonié, Gynecology
      • Caen, France, 14000
        • Centre Francois Baclesse
      • Clermont-Ferrand, France, 63000
        • Centre Jean Perrin
      • Nice, France, Cedex 02 06189
        • Centre Antoine Lacassagne
      • Paris, France, Cedex 15 75015
        • Hopital Europeen Georges Pompidou
      • Paris, France, Cedex 20 75020
        • Hopital Tenon
      • Reims, France, 51056
        • Insitut Jean Godinot, Service Rubis - Oncologie Médicale
      • Rennes, France, 35042
        • Centre Eugène Marquis
      • Rouen, France, 76038
        • Centre Henri Becquerel
      • Rouen, France, 76000
        • Centre Hospitalier Universitaire Charles-Nicolle
      • Saint-Herblain, France, 44805
        • Centre Rene Gauducheau
      • Toulouse, France, 31052
        • Centre Claudius Régaud
  • Germany
      • Bad Homburg, Germany, 61348
        • Hochtaunus-Kliniken gGmbH, Frauenklinik
      • Berlin, Germany, 13353
        • Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Klinik für Frauenheilkunde
      • Dresden, Germany, 01307
        • Universitätsklinikum Carl Gustav Carus, Klinik für Frauenheilkunde u. Geburtshilfe
      • Düsseldorf, Germany, 40217
        • Evangelisches Krankenhaus, Frauenklinik
      • Düsseldorf, Germany, 40489
        • Kaiserswerther-Diakonie, Florence-Nightingale Krankenhaus, Gynäkologie
      • Essen, Germany, 45136
        • Kliniken Essen Mitte, Evang. Huyssens-Stiftung, Gynäkologische Onkologie
      • Frankfurt am Main, Germany, 60591
        • Klinikum der JWG Universität Frankfurt, Klinik für Gynäkologie und Geburtshilfe
      • Freiburg, Germany, 79106
        • Universitätsklinikum Freiburg, Frauenklinik
      • Fürth, Germany, 90766
        • Klinikum Fürth, Frauenklinik Nathanstift
      • Greifswald, Germany, 17487
        • Gynecologic Clinic of the Ernst-Moritz-Arndt-University
      • Göttingen, Germany, 37075
        • Georg-August-Universität Göttingen, Universitäts-Frauenklinik
      • Hannover, Germany, 30625
        • Medizinische Hochschule, Klinik für Frauenheilkunde u. Geburtshilfe
      • Kempten, Germany, 87439
        • Klinikum Kempten, Klinik für Frauenheilkunde und Geburtshilfe
      • Kiel, Germany, 24105
        • Universitätsklinikum Schleswig-Holstein Campus Kiel, Klinik f. Gynäkologie u. Geburtshilfe
      • Konstanz, Germany, 78464
        • Klinikum Konstanz, Frauenklinik
      • Lübeck, Germany, 23538
        • Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Klinik für Frauenheilkunde und Geburtshilfe
      • Mainz, Germany, 55131
        • Universitätsklinikum Mainz, Frauenklinik
      • München, Germany, 80658
        • Klinikum Dritter Orden, Gynäkologie und Geburtshilfe
      • München, Germany, 81377
        • Klinikum der Universität München-Großhadern, Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
      • Ravensburg, Germany, 88212
        • Oberschwaben Klinik, Krankenhaus St. Elisabeth, Frauenklinik
      • Regensburg, Germany, 93053
        • Caritas-Krankenhaus St. Josef, Klinik für Frauenheilkunde und Geburtshilfe d. Universität Regensburg
      • Schweinfurt, Germany, 97422
        • Leopoldina-Krankenhaus der Stadt Schweinfurt GmbH, Frauenklinik
      • Ulm, Germany, 89075
        • Universitätsklinikum, Universitätsfrauenklinik
      • Westerstede, Germany, 26655
        • Ammerland-Klinik GmbH, Frauenklinik
      • Wiesbaden, Germany, 65199
        • HSK, Dr. Horst Schmidt Klinik GmbH, Klinik für Gynäkologie u. Gynäkologische Onkologie
  • Italy
      • Aviano, Italy, 33081
        • Centro di Riferimento Oncologico,Struttura Operativa complessa Chirurgia Oncologica Ginecologica
      • Milan, Italy, 20133
        • Fondazione IRCCS Istituto NAzionale Tumori di Milano
      • Milan, Italy, 20141
        • Istituto Europeo di Oncologia, Divisione di Ginecologia
      • Naples, Italy, 80100
        • Istituto Nazionale Tumori di Napoli, Gynecologic Oncology
  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital, Department of Obstetrics and Gynecology
  • Norway
      • Oslo, Norway, 0310
        • Norwegian Radium Hospital, Oslo University Hospital, Gynecologic Oncology
  • Spain
      • Badalona, Spain, 08916
        • ICO Badalona - H. U. Germans Trias i Pujol
      • Barcelona, Spain, 08025
        • Hospital de la Santa Creu i Sant Pau, Oncology
      • Barcelona, Spain, 08036
        • Hospital Clinic Barcelona, Oncology
      • Girona, Spain, 17007
        • ICO-Hospital Universitari de Girona Dr. Josep Trueta, Servicio de Oncologia de Girona
      • Hospitalet de Llobregat, Spain, 08907
        • Avinguda Granvia de l'Hospitalet de Llobregat, Hospital de Bellvitge, Gynaecology
      • Palma de Mallorca, Spain, 07198
        • Hospital Son Llàtzer, Oncology
      • Pamplona, Spain, 31008
        • Hospital de Navarra, Oncology
      • Valencia, Spain, 46009
        • Fundacion Instituto Valenciano de Oncologia
      • Valencia, Spain, 46026
        • Hospital Universitari i Politècnic la Fe, Oncology
  • Sweden
      • Linköping, Sweden, 58185
        • Linköping University Hospital, Department of Obstetrics and Gynecology
      • Stockholm, Sweden, 17176
        • Karolinska University Hospital, Oncology
  • United Kingdom
      • Birmingham, United Kingdom, B18 7QH
        • Birmingham City Hospital, Cancer Research Team
      • Cambridge, United Kingdom, CB2 2QQ
        • Cambridge University Hospitals NHS FT - Addenbrookes Hospital, Gynaecological Oncology
      • Gateshead, United Kingdom, NE9 6SX
        • Queen Elizabeth Hospital Gateshead, Northern gynaecological oncology centre
      • Guildford, United Kingdom, GU2 7XX
        • Royal Surrey Country Hospital,St Lukes Cancer Centre
      • Lincoln, United Kingdom, LN2 5QY
        • Lincoln County Hospital, Oncology
      • London, United Kingdom, C14 7BE
        • St Bartholomew´s Hospital and Queen´s Hospital,Gynaecological Cancer Centre
      • London, United Kingdom, NW1 2 PG
        • University College London Hospital, Cancer clinical trails unit
      • London, United Kingdom, SW3 6JJ
        • Royal Marsden NHS Foundation Trust, Gynae research, Mulberry House
      • London, United Kingdom, W12 0HS
        • Imperial College Healthcare NHS Trust Hammersmith Hospital, Medical Oncology
      • Manchester, United Kingdom, M13 9W
        • Central Manchester Foundation NHS Trust, St Mary´s Hospital, Gynaecology
      • Margate, United Kingdom, CT9 4AN
        • Queen Elizabeth the Queen Mother Hospital,East Kent Gynaeoncology Centre
      • Northampton, United Kingdom, NN1 5 BD
        • Northampton General Hospital, Gynaecological Oncology
      • Northwood, United Kingdom, HA6 2RN
        • East and North Hertfordhire NHS Trust,Mount Vernon Hospital,Medical Oncology
      • Norwich, United Kingdom, NR4 7UY
        • Norfolk & Norwich University Hospital,Obstetrics & Gynaecology
      • Nottingham, United Kingdom, NG7 2UH
        • Nottingham University Hospital, City Campus, Oncology
      • Sheffield, United Kingdom, S10 2SJ
        • Royal Hallamshire Hospital & Weston Park Hospital, Cancer Clinical Trials Centre
      • Southampton, United Kingdom, SO16 5YA
        • Princess Anne Hospital, gynaecology
      • Wolverhampton, United Kingdom, WV10 OQP
        • New Cross Hospital,Oncology/Gynaecology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Arm - Chemotherapy only
Chemotherapy for platinum-sensitive Ovarian Cancer can be selected on investigators choice
Experimental: Procedure/Surgery
Maximum effort cytoreductive surgery
Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 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
Approximately 36 months after last patient randomized and observation of 244 events

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival
Time Frame: 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
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)
Time Frame: Baseline, 6, and 12 months after randomization
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
Time Frame: Baseline, 6, and 12 months after randomization
Item 11, ranges 0-100
Baseline, 6, and 12 months after randomization
Quality of Life measures with EORTC QLQ-C30 Symptom Scale Constipation
Time Frame: Baseline, 6, and 12 months after randomization
Item 16, ranges 0-100
Baseline, 6, and 12 months after randomization
Quality of Life measures with FACT-G total score
Time Frame: Baseline, 6, and 12 months after randomization
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
Time Frame: Baseline, 6, and 12 months after randomization
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
Time Frame: Baseline, 6, and 12 months after randomization
Sum of FACT-G and and Ovarian Cancer subscale, ranges 0-152
Baseline, 6, and 12 months after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AGO Study Group

Collaborators

Cancer Research UK
ARCAGY/ GINECO GROUP
Grupo Español de Investigación en Cáncer de Ovario
Shanghai Gynecologic Oncology Group

Investigators

  • Principal Investigator: Philipp Harter, MD, AGO Study Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2010

Primary Completion (Actual)

January 17, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

July 16, 2010

First Submitted That Met QC Criteria

July 20, 2010

First Posted (Estimate)

July 21, 2010

Study Record Updates

Last Update Posted (Actual)

January 25, 2022

Last Update Submitted That Met QC Criteria

January 21, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGO-OVAR OP.4 DESKTOP III

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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