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Evaluation of Symptom Benefit Rate of Trabectedin/PLD in Patients With Recurrent Ovarian Cancer

Recurrent Ovarian Carcinoma Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03690739
Study type Interventional
Source AGO Research GmbH
Contact
Status Terminated
Phase Phase 3
Start date August 9, 2019
Completion date March 3, 2021
View Details
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