NCT03164980

QoL-Comparison Between Trabectedin/PLD and Pt-based Therapy in Patients With Pt-sensitive Recurrent Ovarian Cancer

Comparison of Quality of Life (QoL) Between Trabectedin/PLD and Standard Platinum-based Therapy in Patients With Platinum Sensitive Recurrent Ovarian, Fallopian Tube and Peritoneal Cancer

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: North Eastern German Society of Gynaecological Oncology · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, controlled, open-label study including patients with recurrent, platinum-sensitive, ovarian, peritoneal or fallopian tube cancer. The main scope of the trial is to evaluate QoL during chemotherapy comparing trabectedin/PLD with other standard platinum-based chemotherapy in platinum-sensitive disease.

Detailed description

This is a multicenter, randomized, controlled, open-label study including patients with recurrent, platinum-sensitive, ovarian, peritoneal or fallopian tube cancer. The main scope of the trial is to evaluate QoL during chemotherapy comparing trabectedin/PLD with other standard platinum-based chemotherapy in platinum-sensitive disease. Patients with recurrent, platinum-sensitive, ovarian, fallopian tube and peritoneal cancer will be stratified according to surgery for relapse (R0 vs. R1/2 resection) vs. no surgery in the same setting and age (\< 75 years vs. ≥ 75 years), and randomized 1:1 to receive either trabectedin/PLD (Arm A) or one of 3 platinum-based standard therapies without bevacizumab (Arm B, "other standard therapy"). In case of randomization to "other standard therapy", the investigator has the choice between carboplatin/PLD, carboplatin/gemcitabine and carboplatin/paclitaxel. Patients in both treatment arms will receive chemotherapy up for 6 cycles or until disease progression (PD), unacceptable toxicities or patient's wish to stop therapy, whichever occurs first.

Conditions

• Quality of Life
• Ovarian Cancer
• Recurrent Ovarian Carcinoma

Interventions

Type	Name	Description
DRUG	Trabectidin (Yondelis)	To compare QoL in patients treated with trabectedin/PLD vs. other standard combination therapy of carboplatin/ PLD, carboplatin/ gemcitabine, or carboplatin/ paclitaxel

Timeline

• Start date: 2018-02-01
• Primary completion: 2023-08-08
• Completion: 2023-08-08
• First posted: 2017-05-24
• Last updated: 2025-03-20
• Results posted: 2025-03-20

Locations

21 sites across 1 country: Germany