Clinical trial NCT01166737: Study Comparing Tumor Debulking Surgery Versus Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer
Official title: A Randomized Multicenter Study to Compare the Efficacy of Additional Tumor Debulking Surgery vs Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer
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
Lead sponsor: AGO Study Group
Sponsor class: OTHER
Collaborators: name: ARCAGY/ GINECO GROUP
name: Grupo Español de Investigación en Cáncer de Ovario
name: Cancer Research UK
name: Shanghai Gynecologic Oncology Group
First posted: 2010-07-21
Enrollment: 408
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

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 .

Eligibility 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)

Primary outcomes:
measure: Overall survival
timeFrame: Approximately 36 months after last patient randomized and observation of 244 events
Secondary outcomes:
measure: Progression free survival
timeFrame: Progression free survival is defined as interval between date of randomization and 2nd relapse/progression or death (whatever occurs first).
measure: Quality of Life measures with EORTC QLQ-C30 Global Health Status (GHS)
timeFrame: Baseline, 6, and 12 months after randomization
measure: Quality of Life measures with EORTC QLQ-C30 Symptom Scale Insomnia
timeFrame: Baseline, 6, and 12 months after randomization
measure: Quality of Life measures with EORTC QLQ-C30 Symptom Scale Constipation
timeFrame: Baseline, 6, and 12 months after randomization
measure: Quality of Life measures with FACT-G total score
timeFrame: Baseline, 6, and 12 months after randomization
measure: Quality of Life measures with FACT-O Ovarian Cancer subscale
timeFrame: Baseline, 6, and 12 months after randomization
measure: Quality of Life measures with FACT-O total score
timeFrame: Baseline, 6, and 12 months after randomization
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medizinische Universität Graz, Universitätsklinik für Frauenheilkunde Graz, Abteilung Gynäkologie u. Geburtshilfe
city: Innsbruck
country: Austria
facility: Universitätsklinikum Innsbruck, Univ. Klinik für Gynäkologie und Geburtshilfe
city: Wien
country: Austria
facility: Medizinische Universität Wien,Universitätsklinik für Frauenheilkunde
city: Wien
country: Austria
facility: Wilhelminenspital der Stadt Wien, Gynäkologisch und Geburtshilfliche Abteilung
city: Leuven
country: Belgium
facility: UZ Leuven
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital, Gynecology Oncology
city: Shanghai
country: China
facility: Fudan University Cancer Hospital, Gynecologic Oncology
city: Shanghai
country: China
facility: Fudan University Zhongshan Hospital, Obstetrics and Gynecology
city: Suzhou
country: China
facility: Suzhou Municipal Hospital, Gynecologic and Obstetrics
city: Aalborg
country: Denmark
facility: Aalborg Hospital
city: Aarhus
country: Denmark
facility: Aarhus University Hospital,Oncology
city: Copenhagen
country: Denmark
facility: Ringshospitalet Copenhagen University Hospital; Oncology
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Odense
country: Denmark
facility: Odense University Hospital, Gynaecology and Obstetrics
city: Bordeaux
country: France
facility: Institut Bergonié, Gynecology
city: Caen
country: France
facility: Centre Francois Baclesse
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
city: Paris
country: France
facility: Hôpital Tenon
city: Reims
country: France
facility: Insitut Jean Godinot, Service Rubis - Oncologie Médicale
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Rouen
country: France
facility: Centre Hospitalier Universitaire Charles-Nicolle
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Saint-Herblain
country: France
facility: Centre René Gauducheau
city: Toulouse
country: France
facility: Centre Claudius Regaud
city: Bad Homburg
country: Germany
facility: Hochtaunus-Kliniken gGmbH, Frauenklinik
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Klinik für Frauenheilkunde
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus, Klinik für Frauenheilkunde u. Geburtshilfe
city: Düsseldorf
country: Germany
facility: Evangelisches Krankenhaus, Frauenklinik
city: Düsseldorf
country: Germany
facility: Kaiserswerther-Diakonie, Florence-Nightingale Krankenhaus, Gynäkologie
city: Essen
country: Germany
facility: Kliniken Essen Mitte, Evang. Huyssens-Stiftung, Gynäkologische Onkologie
city: Frankfurt am Main
country: Germany
facility: Klinikum der JWG Universität Frankfurt, Klinik für Gynäkologie und Geburtshilfe
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg, Frauenklinik
city: Fürth
country: Germany
facility: Klinikum Fürth, Frauenklinik Nathanstift
city: Greifswald
country: Germany
facility: Gynecologic Clinic of the Ernst-Moritz-Arndt-University
city: Göttingen
country: Germany
facility: Georg-August-Universität Göttingen, Universitäts-Frauenklinik
city: Hannover
country: Germany
facility: Medizinische Hochschule, Klinik für Frauenheilkunde u. Geburtshilfe
city: Kempten
country: Germany
facility: Klinikum Kempten, Klinik für Frauenheilkunde und Geburtshilfe
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein Campus Kiel, Klinik f. Gynäkologie u. Geburtshilfe
city: Konstanz
country: Germany
facility: Klinikum Konstanz, Frauenklinik
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Campus Lübeck, Klinik für Frauenheilkunde und Geburtshilfe
city: Mainz
country: Germany
facility: Universitätsklinikum Mainz, Frauenklinik
city: München
country: Germany
facility: Klinikum Dritter Orden, Gynäkologie und Geburtshilfe
city: München
country: Germany
facility: Klinikum der Universität München-Großhadern, Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe
city: Ravensburg
country: Germany
facility: Oberschwaben Klinik, Krankenhaus St. Elisabeth, Frauenklinik
city: Regensburg
country: Germany
facility: Caritas-Krankenhaus St. Josef, Klinik für Frauenheilkunde und Geburtshilfe d. Universität Regensburg
city: Schweinfurt
country: Germany
facility: Leopoldina-Krankenhaus der Stadt Schweinfurt GmbH, Frauenklinik
city: Ulm
country: Germany
facility: Universitätsklinikum, Universitätsfrauenklinik
city: Westerstede
country: Germany
facility: Ammerland-Klinik GmbH, Frauenklinik
city: Wiesbaden
country: Germany
facility: HSK, Dr. Horst Schmidt Klinik GmbH, Klinik für Gynäkologie u. Gynäkologische Onkologie
city: Aviano
country: Italy
facility: Centro di Riferimento Oncologico,Struttura Operativa complessa Chirurgia Oncologica Ginecologica
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale Tumori di Milano
city: Milan
country: Italy
facility: Istituto Europeo di Oncologia, Divisione di Ginecologia
city: Naples
country: Italy
facility: Istituto Nazionale Tumori di Napoli, Gynecologic Oncology
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital, Department of Obstetrics and Gynecology
city: Oslo
country: Norway
facility: Norwegian Radium Hospital, Oslo University Hospital, Gynecologic Oncology
city: Badalona
country: Spain
facility: ICO Badalona - H. U. Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau, Oncology
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona, Oncology
city: Girona
country: Spain
facility: ICO-Hospital Universitari de Girona Dr. Josep Trueta, Servicio de Oncologia de Girona
city: Hospitalet de Llobregat
country: Spain
facility: Avinguda Granvia de l'Hospitalet de Llobregat, Hospital de Bellvitge, Gynaecology
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llàtzer, Oncology
city: Pamplona
country: Spain
facility: Hospital de Navarra, Oncology
city: Valencia
country: Spain
facility: Fundación Instituto Valenciano de Oncologia
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic la Fe, Oncology
city: Linköping
country: Sweden
facility: Linköping University Hospital, Department of Obstetrics and Gynecology
city: Stockholm
country: Sweden
facility: Karolinska University Hospital, Oncology
city: Birmingham
country: United Kingdom
facility: Birmingham City Hospital, Cancer Research Team
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS FT - Addenbrookes Hospital, Gynaecological Oncology
city: Gateshead
country: United Kingdom
facility: Queen Elizabeth Hospital Gateshead, Northern gynaecological oncology centre
city: Guildford
country: United Kingdom
facility: Royal Surrey Country Hospital,St Lukes Cancer Centre
city: Lincoln
country: United Kingdom
facility: Lincoln County Hospital, Oncology
city: London
country: United Kingdom
facility: St Bartholomew´s Hospital and Queen´s Hospital,Gynaecological Cancer Centre
city: London
country: United Kingdom
facility: University College London Hospital, Cancer clinical trails unit
city: London
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust, Gynae research, Mulberry House
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust Hammersmith Hospital, Medical Oncology
city: Manchester
country: United Kingdom
facility: Central Manchester Foundation NHS Trust, St Mary´s Hospital, Gynaecology
city: Margate
country: United Kingdom
facility: Queen Elizabeth the Queen Mother Hospital,East Kent Gynaeoncology Centre
city: Northampton
country: United Kingdom
facility: Northampton General Hospital, Gynaecological Oncology
city: Northwood
country: United Kingdom
facility: East and North Hertfordhire NHS Trust,Mount Vernon Hospital,Medical Oncology
city: Norwich
country: United Kingdom
facility: Norfolk & Norwich University Hospital,Obstetrics & Gynaecology
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospital, City Campus, Oncology
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital & Weston Park Hospital, Cancer Clinical Trials Centre
city: Southampton
country: United Kingdom
facility: Princess Anne Hospital, gynaecology
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital,Oncology/Gynaecology
Study officials:
affiliation: AGO Study Group
name: Philipp Harter, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.