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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
89
To compare QoL in patients treated with trabectedin/PLD vs. other standard combination therapy of carboplatin/ PLD, carboplatin/ gemcitabine, or carboplatin/ paclitaxel
Universitätsklinikum Aachen
Aachen, Germany
Sankt Gertrauden-Krankenhaus
Berlin, Germany
Difference in Quality of Life (QoL)
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.
Time frame: 12 month (from baseline to end of treatment)
Progression-free Survival
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.
Time frame: 18 month
Overall Survival
Overall survival was defined as time from randomization until date of death to any cause.
Time frame: through study completion, up to 3 years
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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
...and 11 more locations