This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
ARCAGY/ GINECO GROUP
MITO
Arbeitsgemeinschaft Gynaekologische Onkologie Austria
GlaxoSmithKline
medac GmbH
Grupo Español de Investigación en Cáncer de Ovario
NSGO
MaNGO
Cancer Research UK
Korean Gynecologic Oncology Group
Shanghai Gynecologic Oncology Group
Information provided by (Responsible Party):
AGO Study Group
ClinicalTrials.gov Identifier:
NCT01166737
First received: July 16, 2010
Last updated: February 13, 2017
Last verified: February 2017
  Purpose
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.

Condition Intervention
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer Procedure: Tumor Debulking Surgery (surgery in recurrent ovarian disease)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Other
Official Title: A Randomized Multicenter Study to Compare the Efficacy of Additional Tumor Debulking Surgery vs Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer

Resource links provided by NLM:


Further study details as provided by AGO Study Group:

Primary Outcome Measures:
  • Overall survival in patients with platinum-sensitive recurrent ovarian cancer with a positive AGO-score [ Time Frame: Approximately 36 months after last patient randomized and observation of 244 events ]

Secondary Outcome Measures:
  • Quality of Life [ Time Frame: Baseline, 6, and 12 months after randomization ]
    EORTC QLQ 30 and FACT NCCN Ovarian Symptom Index

  • 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). ]

Estimated Enrollment: 408
Study Start Date: July 2010
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01166737

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

Responsible Party: AGO Study Group
ClinicalTrials.gov Identifier: NCT01166737     History of Changes
Other Study ID Numbers: AGO-OVAR OP.4 DESKTOP III
Study First Received: July 16, 2010
Last Updated: February 13, 2017

Keywords provided by AGO Study Group:
Ovarian Cancer
Cancer of the fallopian tube
Primary peritoneal cancer
Recurrent disease
Platinum-sensitive
Surgery
Chemotherapy
Quality of Life
First recurrence of platinum sensitive:
Fallopian Tube Cancer
or Ovarian Cancer
or Peritoneal Cavity Cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Fallopian Tube Neoplasms
Hypersensitivity
Peritoneal Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Fallopian Tube Diseases
Immune System Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases

ClinicalTrials.gov processed this record on July 14, 2017