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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
408

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 François Baclesse
      • Clermont-Ferrand, France, 63000
        • Centre Jean Perrin
      • Nice, France, Cedex 02 06189
        • Centre Antoine Lacassagne
      • Paris, France, Cedex 15 75015
        • Hôpital Européen 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 Regaud
  • 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
        • Fundación Instituto Valenciano De Oncología
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AGO Study Group

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cancer Research UK
ARCAGY/ GINECO GROUP
Grupo Español de Investigación en Cáncer de Ovario
Shanghai Gynecologic Oncology Group

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 17, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 25, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings