QoL-Comparison Between Trabectedin/PLD and Pt-based Therapy in Patients With Pt-sensitive Recurrent Ovarian Cancer
- Conditions
- Recurrent Ovarian CarcinomaQuality of LifeOvarian Cancer
- Interventions
- Drug: Trabectidin (Yondelis)
- Registration Number
- NCT03164980
- Brief 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 89
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A Trabectidin (Yondelis) PLD followed by Trabectedin. Treatment is repeated every 3 weeks for 6 cycles or until disease progression. Arm B Trabectidin (Yondelis) * Carboplatin/PLD * Carboplatin/Gemcitabine * Carboplatin/Paclitaxel Patients will be treated for 6 cycles or until PD, unacceptable toxicity or patient's wish to discontinue, whichever occurs first.
- Primary Outcome Measures
Name Time Method Difference in Quality of Life (QoL) 12 month (from baseline to end of treatment) The difference in QoL is defined as change of the mean score of the Trial Outcome Index (TOI) from baseline (TOI at randomization) compared to end of treatment (TOI at EOT) and is calculated as follows:
Difference TOI = TOI at EOT - TOI at baseline.
1. equals to 0 meaning no change in quality of life at EOT compared to baseline
2. \>0 meaning a detoriated quality of life at EOT compared to baseline. (The higher the number, the higher the detoriation.)
3. \<0 meaning an improved quality of life at EOT compared to baseline. (The lower the number, the higher the improvement.)
TOI is calculated as mean of subscores concerning functional scales (e.g. physical function) and symptomal scales (e.g. body image, chemotherapy side effects, attitude to disease/treatment). Scores of each scale are transformed and ranges between 0-100. High scores for functional scales and symptomal scales meaning a low level of functioning and a high level of symptomatology/problems, respectively.
- Secondary Outcome Measures
Name Time Method Progression-free Survival 18 month Progression-free survival was defined as time (months) from randomization until date of the first occurrence of progression or recurrence, as determined by the investigator using CT criteria, or death from any cause.
Overall Survival through study completion, up to 3 years Overall survival was defined as time from randomization until date of death to any cause.
Trial Locations
- Locations (21)
Universitätsklinikum Aachen
🇩🇪Aachen, Germany
Sankt Gertrauden-Krankenhaus
🇩🇪Berlin, Germany
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum
🇩🇪Berlin, Germany
Praxis Krebsheilkunde für Frauen
🇩🇪Berlin, Germany
Medizinisches Zentrum Bonn Friedensplatz
🇩🇪Bonn, Germany
Universitätsklinikum Brandenburg an der Havel
🇩🇪Brandenburg an der Havel, Germany
Studien GbR Braunschweig
🇩🇪Braunschweig, Germany
Städtisches Klinikum Dessau
🇩🇪Dessau, Germany
Frauenklinik Carl Gustav Carus
🇩🇪Dresden, Germany
Onkologische Schwerpunktpraxis
🇩🇪Dresden, Germany
Krankenhaus Nordwest gGmbH
🇩🇪Frankfurt, Germany
Universitätsklinikum Freiburg
🇩🇪Freiburg, Germany
ZAGO am Helios Klinikum Krefeld
🇩🇪Krefeld, Germany
Universitätsfrauenklinik Leipzig
🇩🇪Leipzig, Germany
Universitätsklinik der Johannes Gutenberg-Universität Mainz
🇩🇪Mainz, Germany
Ruppiner Kliniken GmbH
🇩🇪Neuruppin, Germany
Sana Klinikum Offenbach
🇩🇪Offenbach, Germany
Klinikum Südstadt Rostock
🇩🇪Rostock, Germany
Caritas Klinikum St. Theresia
🇩🇪Saarbrücken, Germany
Krankenhaus Saarlouis vom DRK
🇩🇪Saarlouis, Germany
Christliches Klinikum Unna gGmbH
🇩🇪Unna, Germany