Spots Global Cancer Trial Database for Evaluation of Symptom Benefit Rate of Trabectedin/PLD in Patients With Recurrent Ovarian Cancer
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Trial Identification
Brief Title: Evaluation of Symptom Benefit Rate of Trabectedin/PLD in Patients With Recurrent Ovarian Cancer
Official Title: Trabectedin/PLD Versus Continuation of Platinum-based Chemo-therapy in Patients With Disease Stabilization and no Symptom Benefit Under Platinum-based Chemotherapy for Recurrent Ovarian Cancer
Study ID: NCT03690739
Conditions
Study Description
Brief Summary: This is an open-label, prospective, randomized, controlled, parallel group, multi-center phase III trial to evaluate the Symptom Benefit Rate of trabectedin/PLD in patients with recurrent ovarian cancer who achieve a stabilization of disease after 3 cycles of platinum-based reinduction therapy and with no clinical benefit.
Detailed Description: Approximately 330 patients will be randomized in a 1:1 ration to the treatments specified below: Arm A - Platinum-based chemotherapy according to investigator's discretion Arm B - Pegylated liposomal doxorubicin 30 mg/m² + Trabectedin 1.1 mg/m² (q3w)
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Klinikum Aschaffenburg-Alzenau, Aschaffenburg, Bayern, Germany
Hochtaunus-Kliniken, Bad Homburg, , Germany
Sozialstiftung Bamberg, Bamberg, , Germany
Evangelisches Krankenhaus Bergisch Gladbach, Bergisch Gladbach, , Germany
CharitÊ - Universitätsmedizin Berlin, Berlin, , Germany
Universitätsfrauenklinik Bonn, Bonn, , Germany
Schwerpunktpraxis fßr Onkologie / Hämatologie, Bottrop, , Germany
Frauenärzte CasparistraĂe, Braunschweig, , Germany
Universitätsklinikum Carl Gustav Carus, Dresden, , Germany
Evang. Kliniken Essen-Mitte, Essen, , Germany
Agaplesion Markus Krankenhaus, Frankfurt, , Germany
Universitätsmedizin Greifswald, Greifswald, , Germany
Mammazentrum Hamburg am Krankenhaus Jerusalem, Hamburg, , Germany
Klinikum Itzehoe, Itzehoe, , Germany
ViDia Christliche Kliniken Karlsruhe, Karlsruhe, , Germany
Klinikum Ludwigsburg, Ludwigsburg, , Germany
Klinikum Magdeburg, Magdeburg, , Germany
Katholisches Klinikum Mainz, Mainz, , Germany
Universitätsfrauenklinik Mannheim, Mannheim, , Germany
Klinikum Memmingen, Memmingen, , Germany
Klinikum rechts der Isar, MĂźnchen, , Germany
Kliniken des Landkreises Neumarkt, Neumarkt, , Germany
Universitätsklinik fßr Innere Medizin, Onkologie und Hämatologie, Oldenburg, , Germany
Klinikum Ernst von Bergmann, Potsdam, , Germany
Agaplesion Diakonieklinikum Rotenburg, Rotenburg, , Germany
ThĂźringen Kliniken "Georgius Agricola", Saalfeld, , Germany
g.Sund Gyn. Kompetenzzentrum, Stralsund, , Germany
Kreiskrankenhaus "Johann Kentmann", Torgau, , Germany
Helios Dr. Horst Schmidt Kliniken, Wiesbaden, , Germany
Contact Details
Name: Felix Hilpert, MD, PhD
Affiliation: Mammazentrum am Krankenhaus Jerusalem, Hamburg
Role: STUDY_CHAIR
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