Study Comparing Tumor Debulking Surgery Versus Chemotherapy Alone in Recurrent Platinum-Sensitive Ovarian Cancer
Conditions
Fallopian Tube Cancer - Ovarian Cancer - Peritoneal Cavity Cancer
Conditions: official terms
Fallopian Tube Neoplasms - Ovarian Neoplasms - Peritoneal Neoplasms
Conditions: 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
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Intervention
Name: Tumor Debulking Surgery (surgery in recurrent ovarian disease)
Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
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)
Locations
Ostalbklinikum
Aalen, Germany
Status: Recruiting
Charité - Universitätsmedizin Berlin, Campus Virchow-Klinikum, Klinik für Frauenheilkunde
Berlin, Germany
Status: Recruiting
Univerisity Hospital; Dept. of Gynecology & Obstetrics
Erlangen, Germany
Status: Recruiting
Kliniken Essen Mitte, Evang. Huyssens-Stiftung
Essen, Germany
Status: Not yet recruiting
University hospital, Dept. of gynecology & obstetrics
Essen, Germany
Status: Recruiting
Contact: , MD
Klinikum Esslingen
Esslingen, Germany
Status: Recruiting
Klinikum der JWG Universität Frankfurt
Frankfurt am Main, Germany
Status: Recruiting
Universitätsklinikum Freiburg, Frauenklinik
Freiburg, Germany
Status: Recruiting
Gynecologic Clinic of the Ernst-Moritz-Arndt-University
Greifswald, Germany
Status: Recruiting
Medizinische Hochschule
Hannover, Germany
Status: Recruiting
Universitätsklinikum Schleswig-Holstein Campus Kiel, Klinik f. Gynäkologie u. Geburtshilfe
Kiel, Germany
Status: Recruiting
Klinikum der Philipps-Universität Marburg, Klinik für Gynäkologie, Gynäkologische Endokrinologie
Marburg, Germany
Status: Recruiting
St. Josefsklinik
Offenburg, Germany
Status: Recruiting
St. Vincenz-Krankenhaus
Paderborn, Germany
Status: Recruiting
Klinikum Südstadt
Rostock, Germany
Status: Recruiting
Universitätsklinikum, Universitätsfrauenklinik
Ulm, Germany
Status: Recruiting
HSK, Dr. Horst Schmidt Klinik GmbH
Wiesbaden, Germany
Status: Recruiting
Contact: - office-wiesbaden@ago-ovar.de
Klinikum der Stadt Wolfsburg
Wolfsburg, Germany
Status: Recruiting
Start Date
July 2010
Completion Date
December 2016
Sponsors
AGO Study Group
Source
AGO Study Group
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page