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

Ovarian Cancer Clinical Trial

— DESKTOPIII  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01166737
• Other study ID #: AGO-OVAR OP.4 DESKTOP III
• Status: Completed
• Phase: N/A
• Start date: July 2010
• Est. completion date: December 31, 2020

Study information

• Verified date: December 2021
• Source: AGO Study Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 408
• Est. completion date: December 31, 2020
• Est. primary completion date: January 17, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Hypersensitivity
• Ovarian Cancer
• Ovarian Neoplasms
• Peritoneal Cavity Cancer

Intervention

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

Locations

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

Sponsors (5)

Lead Sponsor	Collaborator
AGO Study Group	ARCAGY/ GINECO GROUP, Cancer Research UK, Grupo Español de Investigación en Cáncer de Ovario, Shanghai Gynecologic Oncology Group

Countries where clinical trial is conducted

Austria,  Belgium,  China,  Denmark,  France,  Germany,  Italy,  Korea, Republic of,  Norway,  Spain,  Sweden,  United Kingdom, 

References & Publications (1)

Harter P, Sehouli J, Vergote I, Ferron G, Reuss A, Meier W, Greggi S, Mosgard BJ, Selle F, Guyon F, Pomel C, Lécuru 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	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	Progression free survival	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).
Secondary	Quality of Life measures with EORTC QLQ-C30 Global Health Status (GHS)	GHS scale-core item 29, 30; ranges 0-100	Baseline, 6, and 12 months after randomization
Secondary	Quality of Life measures with EORTC QLQ-C30 Symptom Scale Insomnia	Item 11, ranges 0-100	Baseline, 6, and 12 months after randomization
Secondary	Quality of Life measures with EORTC QLQ-C30 Symptom Scale Constipation	Item 16, ranges 0-100	Baseline, 6, and 12 months after randomization
Secondary	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	Baseline, 6, and 12 months after randomization
Secondary	Quality of Life measures with FACT-O Ovarian Cancer subscale	Composite of 11 items regarding specific to Ovarian Cancer patients, ranges 0-44	Baseline, 6, and 12 months after randomization
Secondary	Quality of Life measures with FACT-O total score	Sum of FACT-G and and Ovarian Cancer subscale, ranges 0-152	Baseline, 6, and 12 months after randomization