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

Sponsor:	AGO Study Group
Collaborators:	ARCAGY/ GINECO GROUP MITO Arbeitsgemeinschaft Gynaekologische Onkologie Austria GlaxoSmithKline medac GmbH
Information provided by:	AGO Study Group
ClinicalTrials.gov Identifier:	NCT01166737

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	Phase
Fallopian Tube Cancer Ovarian Cancer Malignant Tumor of Peritoneum	Procedure: Tumor Debulking Surgery (surgery in recurrent ovarian disease)	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label
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:

MedlinePlus related topics: Cancer Ovarian Cancer

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Quality of Life [ Time Frame: Baseline, 6, and 12 months after randomization ] [ Designated as safety issue: No ]
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). ] [ Designated as safety issue: No ]

Estimated Enrollment:	408
Study Start Date:	July 2010
Estimated Study Completion Date:	December 2016
Estimated Primary Completion Date:	July 2016 (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
Genders 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

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

Contacts

Contact: Philipp Harter, MD	+49 (0)611 880 4670	office-wiesbaden@ago-ovar.de
Contact: Andreas du Bois, Professor	+49 (0)611 880 4670	office-wiesbaden@ago-ovar.de

Locations

Germany
Ostalbklinikum	Recruiting
Aalen, Germany, 73430
Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Klinik für Frauenheilkunde	Recruiting
Berlin, Germany, 13353
Univerisity Hospital; Dept. of Gynecology & Obstetrics	Recruiting
Erlangen, Germany, 91054
University hospital, Dept. of gynecology & obstetrics	Recruiting
Essen, Germany, 45122
Contact: , MD
Kliniken Essen Mitte, Evang. Huyssens-Stiftung	Not yet recruiting
Essen, Germany
Klinikum Esslingen	Recruiting
Esslingen, Germany, 73730
Klinikum der JWG Universität Frankfurt	Recruiting
Frankfurt am Main, Germany, 60591
Universitätsklinikum Freiburg, Frauenklinik	Recruiting
Freiburg, Germany, 79106
Gynecologic Clinic of the Ernst-Moritz-Arndt-University	Recruiting
Greifswald, Germany, 17487
Medizinische Hochschule	Recruiting
Hannover, Germany, 30625
Universitätsklinikum Schleswig-Holstein Campus Kiel, Klinik f. Gynäkologie u. Geburtshilfe	Recruiting
Kiel, Germany, 24105
Klinikum der Philipps-Universität Marburg, Klinik für Gynäkologie, Gynäkologische Endokrinologie	Recruiting
Marburg, Germany, 35037
St. Josefsklinik	Recruiting
Offenburg, Germany, 77654
St. Vincenz-Krankenhaus	Recruiting
Paderborn, Germany, 33098
Klinikum Südstadt	Recruiting
Rostock, Germany, 18059
Universitätsklinikum, Universitätsfrauenklinik	Recruiting
Ulm, Germany, 89075
HSK, Dr. Horst Schmidt Klinik GmbH	Recruiting
Wiesbaden, Germany
Contact office-wiesbaden@ago-ovar.de
Klinikum der Stadt Wolfsburg	Recruiting
Wolfsburg, Germany, 38440

Sponsors and Collaborators

AGO Study Group

ARCAGY/ GINECO GROUP

MITO

Arbeitsgemeinschaft Gynaekologische Onkologie Austria

GlaxoSmithKline

medac GmbH

More Information

No publications provided

Responsible Party:	AGO Research GmbH
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 24, 2011
Health Authority:	Germany: Ethics Commission

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:

Neoplasms
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female

Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases

ClinicalTrials.gov processed this record on February 09, 2012