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Fallopian Tube CancerDESKTOPIIINCT01166737

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

A study testing Tumor Debulking Surgery (surgery in recurrent ovarian disease) in people with Fallopian Tube Cancer and Ovarian Cancer, run by AGO Study Group at 86 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Tumor Debulking Surgery (surgery in recurrent ovarian disease)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
408 participants
Where
86 sitesin 12 countries
Study dates
Jul 2010to 31 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
  • Performance status ECOG 0
  • 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.
  • 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.

Who cannot join

  • 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
Show all 11Show fewer
  • 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)

Trial locations and contacts

86 sites in 12 countries.

86 sites in 12 countries

Germany25 sites

  • Hochtaunus-Kliniken gGmbH, Frauenklinik

    Bad Homburg, 61348

  • Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Klinik für Frauenheilkunde

    Berlin, 13353

  • Universitätsklinikum Carl Gustav Carus, Klinik für Frauenheilkunde u. Geburtshilfe

    Dresden, 01307

  • Evangelisches Krankenhaus, Frauenklinik

    Düsseldorf, 40217

  • Kaiserswerther-Diakonie, Florence-Nightingale Krankenhaus, Gynäkologie

    Düsseldorf, 40489

  • Kliniken Essen Mitte, Evang. Huyssens-Stiftung, Gynäkologische Onkologie

    Essen, 45136

  • Klinikum der JWG Universität Frankfurt, Klinik für Gynäkologie und Geburtshilfe

    Frankfurt am Main, 60591

  • Universitätsklinikum Freiburg, Frauenklinik

    Freiburg im Breisgau, 79106

  • Klinikum Fürth, Frauenklinik Nathanstift

    Fürth, 90766

  • Georg-August-Universität Göttingen, Universitäts-Frauenklinik

    Göttingen, 37075

  • Gynecologic Clinic of the Ernst-Moritz-Arndt-University

    Greifswald, 17487

  • Medizinische Hochschule, Klinik für Frauenheilkunde u. Geburtshilfe

    Hanover, 30625

  • Klinikum Kempten, Klinik für Frauenheilkunde und Geburtshilfe

    Kempten, 87439

  • Universitätsklinikum Schleswig-Holstein Campus Kiel, Klinik f. Gynäkologie u. Geburtshilfe

    Kiel, 24105

  • Klinikum Konstanz, Frauenklinik

    Konstanz, 78464

  • Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Klinik für Frauenheilkunde und Geburtshilfe

    Lübeck, 23538

  • Universitätsklinikum Mainz, Frauenklinik

    Mainz, 55131

  • Klinikum Dritter Orden, Gynäkologie und Geburtshilfe

    München, 80658

  • Klinikum der Universität München-Großhadern, Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe

    München, 81377

  • Oberschwaben Klinik, Krankenhaus St. Elisabeth, Frauenklinik

    Ravensburg, 88212

  • Caritas-Krankenhaus St. Josef, Klinik für Frauenheilkunde und Geburtshilfe d. Universität Regensburg

    Regensburg, 93053

  • Leopoldina-Krankenhaus der Stadt Schweinfurt GmbH, Frauenklinik

    Schweinfurt, 97422

  • Universitätsklinikum, Universitätsfrauenklinik

    Ulm, 89075

  • Ammerland-Klinik GmbH, Frauenklinik

    Westerstede, 26655

  • HSK, Dr. Horst Schmidt Klinik GmbH, Klinik für Gynäkologie u. Gynäkologische Onkologie

    Wiesbaden, 65199

Other trials in Germany

United Kingdom18 sites

  • Birmingham City Hospital, Cancer Research Team

    Birmingham, B18 7QH

  • Cambridge University Hospitals NHS FT - Addenbrookes Hospital, Gynaecological Oncology

    Cambridge, CB2 2QQ

  • Queen Elizabeth Hospital Gateshead, Northern gynaecological oncology centre

    Gateshead, NE9 6SX

  • Royal Surrey Country Hospital,St Lukes Cancer Centre

    Guildford, GU2 7XX

  • Lincoln County Hospital, Oncology

    Lincoln, LN2 5QY

  • St Bartholomew´s Hospital and Queen´s Hospital,Gynaecological Cancer Centre

    London, C14 7BE

  • University College London Hospital, Cancer clinical trails unit

    London, NW1 2 PG

  • Royal Marsden NHS Foundation Trust, Gynae research, Mulberry House

    London, SW3 6JJ

  • Imperial College Healthcare NHS Trust Hammersmith Hospital, Medical Oncology

    London, W12 0HS

  • Central Manchester Foundation NHS Trust, St Mary´s Hospital, Gynaecology

    Manchester, M13 9W

  • Queen Elizabeth the Queen Mother Hospital,East Kent Gynaeoncology Centre

    Margate, CT9 4AN

  • Northampton General Hospital, Gynaecological Oncology

    Northampton, NN1 5 BD

  • East and North Hertfordhire NHS Trust,Mount Vernon Hospital,Medical Oncology

    Northwood, HA6 2RN

  • Norfolk & Norwich University Hospital,Obstetrics & Gynaecology

    Norwich, NR4 7UY

  • Nottingham University Hospital, City Campus, Oncology

    Nottingham, NG7 2UH

  • Royal Hallamshire Hospital & Weston Park Hospital, Cancer Clinical Trials Centre

    Sheffield, S10 2SJ

  • Princess Anne Hospital, gynaecology

    Southampton, SO16 5YA

  • New Cross Hospital,Oncology/Gynaecology

    Wolverhampton, WV10 OQP

Other trials in United Kingdom

France12 sites

  • Institut Bergonié, Gynecology

    Bordeaux, 33076

  • Centre Francois Baclesse

    Caen, 14000

  • Centre Jean Perrin

    Clermont-Ferrand, 63000

  • Centre Antoine Lacassagne

    Nice, Cedex 02 06189

  • Hôpital Européen Georges Pompidou

    Paris, Cedex 15 75015

  • Hôpital Tenon

    Paris, Cedex 20 75020

  • Insitut Jean Godinot, Service Rubis - Oncologie Médicale

    Reims, 51056

  • Centre Eugène Marquis

    Rennes, 35042

  • Centre Hospitalier Universitaire Charles-Nicolle

    Rouen, 76000

  • Centre Henri Becquerel

    Rouen, 76038

  • Centre René Gauducheau

    Saint-Herblain, 44805

  • Centre Claudius Regaud

    Toulouse, 31052

Other trials in France

Spain9 sites

  • ICO Badalona - H. U. Germans Trias i Pujol

    Badalona, 08916

  • Hospital de la Santa Creu i Sant Pau, Oncology

    Barcelona, 08025

  • Hospital Clinic Barcelona, Oncology

    Barcelona, 08036

  • ICO-Hospital Universitari de Girona Dr. Josep Trueta, Servicio de Oncologia de Girona

    Girona, 17007

  • Avinguda Granvia de l'Hospitalet de Llobregat, Hospital de Bellvitge, Gynaecology

    L'Hospitalet de Llobregat, 08907

  • Hospital Son Llàtzer, Oncology

    Palma de Mallorca, 07198

  • Hospital de Navarra, Oncology

    Pamplona, 31008

  • Fundación Instituto Valenciano de Oncologia

    Valencia, 46009

  • Hospital Universitari i Politècnic la Fe, Oncology

    Valencia, 46026

Other trials in Spain

Denmark5 sites

  • Aalborg Hospital

    Aalborg, 9000

  • Aarhus University Hospital,Oncology

    Aarhus, 8000

  • Ringshospitalet Copenhagen University Hospital; Oncology

    Copenhagen, 2100

  • Herlev Hospital

    Herlev, 2730

  • Odense University Hospital, Gynaecology and Obstetrics

    Odense, 5000

Other trials in Denmark

Austria4 sites

  • Medizinische Universität Graz, Universitätsklinik für Frauenheilkunde Graz, Abteilung Gynäkologie u. Geburtshilfe

    Graz, 8036

  • Universitätsklinikum Innsbruck, Univ. Klinik für Gynäkologie und Geburtshilfe

    Innsbruck, 6020

  • Medizinische Universität Wien,Universitätsklinik für Frauenheilkunde

    Vienna, 1090

  • Wilhelminenspital der Stadt Wien, Gynäkologisch und Geburtshilfliche Abteilung

    Vienna, 1160

Other trials in Austria

China4 sites

  • Zhejiang Cancer Hospital, Gynecology Oncology

    Hangzhou, 310022

  • Fudan University Cancer Hospital, Gynecologic Oncology

    Shanghai, 200032

  • Fudan University Zhongshan Hospital, Obstetrics and Gynecology

    Shanghai, 200032

  • Suzhou Municipal Hospital, Gynecologic and Obstetrics

    Suzhou, 215002

Other trials in China

Italy4 sites

  • Centro di Riferimento Oncologico,Struttura Operativa complessa Chirurgia Oncologica Ginecologica

    Aviano, 33081

  • Fondazione IRCCS Istituto Nazionale Tumori di Milano

    Milan, 20133

  • Istituto Europeo di Oncologia, Divisione di Ginecologia

    Milan, 20141

  • Istituto Nazionale Tumori di Napoli, Gynecologic Oncology

    Naples, 80100

Other trials in Italy

Sweden2 sites

  • Linköping University Hospital, Department of Obstetrics and Gynecology

    Linköping, 58185

  • Karolinska University Hospital, Oncology

    Stockholm, 17176

Other trials in Sweden

Belgium1 site

  • UZ Leuven

    Leuven

Other trials in Belgium

Norway1 site

  • Norwegian Radium Hospital, Oslo University Hospital, Gynecologic Oncology

    Oslo, 0310

Other trials in Norway

South Korea1 site

  • Seoul National University Hospital, Department of Obstetrics and Gynecology

    Seoul, 110-744

Other trials in South Korea

About this study

Official title: 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.

Read the 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 .

Being tested
Tumor Debulking Surgery (surgery in recurrent ovarian disease)
Keywords
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
Medical subject headings
Fallopian Tube Neoplasms, Ovarian Neoplasms, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tumor Debulking Surgery (surgery in recurrent ovarian disease)Procedure or surgery

    Surgery for Patients with platinum-sensitive recurrent ovarian cancer with a positive AGO-score predictive for complete tumor resection

Study groups in NCT01166737
Study groupRoleWhat they receive
Control Arm - Chemotherapy onlyNo interventionChemotherapy for platinum-sensitive Ovarian Cancer can be selected on investigators choice
Procedure/SurgeryExperimentalMaximum effort cytoreductive surgery
Receives: Procedure: Tumor Debulking Surgery (surgery in recurrent ovarian disease)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    in patients with platinum-sensitive recurrent ovarian cancer with a positive AGO Score

    Measured: Approximately 36 months after last patient randomized and observation of 244 events

Secondary outcomes (7)

  1. Progression free survival

    patients with platinum-sensitive recurrent ovarian cancer with a positive AGO Score

    Measured: Progression free survival is defined as interval between date of randomization and 2nd relapse/progression or death (whatever occurs first).

  2. Quality of Life measures with EORTC QLQ-C30 Global Health Status (GHS)

    GHS scale-core item 29, 30; ranges 0-100

    Measured: Baseline, 6, and 12 months after randomization

  3. Quality of Life measures with EORTC QLQ-C30 Symptom Scale Insomnia

    Item 11, ranges 0-100

    Measured: Baseline, 6, and 12 months after randomization

  4. Quality of Life measures with EORTC QLQ-C30 Symptom Scale Constipation

    Item 16, ranges 0-100

    Measured: Baseline, 6, and 12 months after randomization

  5. 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

    Measured: Baseline, 6, and 12 months after randomization

  6. Quality of Life measures with FACT-O Ovarian Cancer subscale

    Composite of 11 items regarding specific to Ovarian Cancer patients, ranges 0-44

    Measured: Baseline, 6, and 12 months after randomization

  7. Quality of Life measures with FACT-O total score

    Sum of FACT-G and and Ovarian Cancer subscale, ranges 0-152

    Measured: Baseline, 6, and 12 months after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2010 (estimated)
  2. Study startJul 2010
  3. Primary completion17 Jan 2020
  4. Study completion31 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
408 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01166737
Sponsor's protocol ID
AGO-OVAR OP.4 DESKTOP III
Acronym
DESKTOPIII
Status last verified
Dec 2021
First submitted
16 Jul 2010
Last updated
25 Jan 2022
Results posted
No
Data monitoring committee
Yes

Publications

  • Harter P, Sehouli J, Vergote I, Ferron G, Reuss A, Meier W, Greggi S, Mosgaard BJ, Selle F, Guyon F, Pomel C, Lecuru 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, Mirza MR, Lund B, Reinthaller A, Santaballa A, Olaitan A, Hilpert F, du Bois A; DESKTOP III Investigators. Randomized Trial of Cytoreductive Surgery for Relapsed Ovarian Cancer. N Engl J Med. 2021 Dec 2;385(23):2123-2131. doi: 10.1056/NEJMoa2103294.

    PubMed 34874631

  • Bommert M, Harter P, Heitz F, du Bois A. When should Surgery be used for Recurrent Ovarian Carcinoma? Clin Oncol (R Coll Radiol). 2018 Aug;30(8):493-497. doi: 10.1016/j.clon.2018.04.006. Epub 2018 May 7.

    PubMed 29743148

Questions about this trial

What is this clinical trial studying?

A study testing Tumor Debulking Surgery (surgery in recurrent ovarian disease) in people with Fallopian Tube Cancer and Ovarian Cancer, run by AGO Study Group at 86 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 sites in Germany, United Kingdom, France, Spain, Denmark and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: Approximately 36 months after last patient randomized and observation of 244 events). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01166737, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2022.

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