Trial Outcomes & Findings for QoL-Comparison Between Trabectedin/PLD and Pt-based Therapy in Patients With Pt-sensitive Recurrent Ovarian Cancer (NCT NCT03164980)
NCT ID: NCT03164980
Last Updated: 2025-03-20
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
89 participants
Primary outcome timeframe
12 month (from baseline to end of treatment)
Results posted on
2025-03-20
Participant Flow
recruitment period:01.02.2018 - 28.03.2023
A total of 204 patients were planned to be randomized. Due to slow recruitment of the trial, the recruitment was prematurely terminated after randomization of the 89th patient.
Participant milestones
| Measure |
Arm A
PLD followed by Trabectedin. Treatment is repeated every 3 weeks for 6 cycles or until disease progression.
Trabectidin (Yondelis): To compare QoL in patients treated with trabectedin/PLD vs. other standard combination therapy of carboplatin/ PLD, carboplatin/ gemcitabine, or carboplatin/ paclitaxel
|
Arm B
* 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.
Trabectidin (Yondelis): To compare QoL in patients treated with trabectedin/PLD vs. other standard combination therapy of carboplatin/ PLD, carboplatin/ gemcitabine, or carboplatin/ paclitaxel
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
44
|
|
Overall Study
COMPLETED
|
44
|
41
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Arm A
n=44 Participants
PLD followed by Trabectedin. Treatment is repeated every 3 weeks for 6 cycles or until disease progression.
Trabectidin (Yondelis): To compare QoL in patients treated with trabectedin/PLD vs. other standard combination therapy of carboplatin/ PLD, carboplatin/ gemcitabine, or carboplatin/ paclitaxel
|
Arm B
n=41 Participants
* 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.
Trabectidin (Yondelis): To compare QoL in patients treated with trabectedin/PLD vs. other standard combination therapy of carboplatin/ PLD, carboplatin/ gemcitabine, or carboplatin/ paclitaxel
|
Total
n=85 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.3 years
STANDARD_DEVIATION 10.9 • n=44 Participants
|
64.9 years
STANDARD_DEVIATION 9.6 • n=41 Participants
|
62.5 years
STANDARD_DEVIATION 10.5 • n=85 Participants
|
|
Age, Customized
< 70 years
|
36 Participants
n=44 Participants
|
27 Participants
n=41 Participants
|
63 Participants
n=85 Participants
|
|
Age, Customized
>= 70 years
|
8 Participants
n=44 Participants
|
14 Participants
n=41 Participants
|
22 Participants
n=85 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=44 Participants
|
41 Participants
n=41 Participants
|
85 Participants
n=85 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=44 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=85 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body Mass Index (BMI)
|
25.3 kg/m²
STANDARD_DEVIATION 5.2 • n=44 Participants
|
26.2 kg/m²
STANDARD_DEVIATION 5.5 • n=41 Participants
|
25.7 kg/m²
STANDARD_DEVIATION 5.4 • n=85 Participants
|
|
ECOG
0
|
17 Participants
n=44 Participants
|
13 Participants
n=41 Participants
|
30 Participants
n=85 Participants
|
|
ECOG
1
|
27 Participants
n=44 Participants
|
27 Participants
n=41 Participants
|
54 Participants
n=85 Participants
|
|
ECOG
2
|
0 Participants
n=44 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=85 Participants
|
|
ECOG
3
|
0 Participants
n=44 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=85 Participants
|
|
ECOG
4
|
0 Participants
n=44 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=85 Participants
|
|
ECOG
5
|
0 Participants
n=44 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=85 Participants
|
|
Localization of the primary tumor
Primary peritoneal carcinoma
|
3 participants
n=44 Participants
|
4 participants
n=41 Participants
|
7 participants
n=85 Participants
|
|
Localization of the primary tumor
Primary ovarian carcinoma
|
37 participants
n=44 Participants
|
34 participants
n=41 Participants
|
71 participants
n=85 Participants
|
|
Localization of the primary tumor
Tube carcinoma
|
4 participants
n=44 Participants
|
3 participants
n=41 Participants
|
7 participants
n=85 Participants
|
|
Histology of primary tumor
Clear cell
|
2 participants
n=44 Participants
|
3 participants
n=41 Participants
|
5 participants
n=85 Participants
|
|
Histology of primary tumor
Mucinous
|
0 participants
n=44 Participants
|
1 participants
n=41 Participants
|
1 participants
n=85 Participants
|
|
Histology of primary tumor
Serous
|
42 participants
n=44 Participants
|
37 participants
n=41 Participants
|
79 participants
n=85 Participants
|
|
Histological grade
grade 1
|
2 participants
n=44 Participants
|
0 participants
n=41 Participants
|
2 participants
n=85 Participants
|
|
Histological grade
grade 2
|
1 participants
n=44 Participants
|
1 participants
n=41 Participants
|
2 participants
n=85 Participants
|
|
Histological grade
grade 3
|
6 participants
n=44 Participants
|
2 participants
n=41 Participants
|
8 participants
n=85 Participants
|
|
Histological grade
grade 4
|
0 participants
n=44 Participants
|
0 participants
n=41 Participants
|
0 participants
n=85 Participants
|
|
Histological grade
Missing
|
35 participants
n=44 Participants
|
38 participants
n=41 Participants
|
73 participants
n=85 Participants
|
|
Metastasis staging (according to TNM staging system)
M0
|
23 participants
n=44 Participants
|
18 participants
n=41 Participants
|
41 participants
n=85 Participants
|
|
Metastasis staging (according to TNM staging system)
M1
|
20 participants
n=44 Participants
|
23 participants
n=41 Participants
|
43 participants
n=85 Participants
|
|
Metastasis staging (according to TNM staging system)
Missing
|
1 participants
n=44 Participants
|
0 participants
n=41 Participants
|
1 participants
n=85 Participants
|
|
Number of previous chemotherapies
1
|
32 participants
n=44 Participants
|
36 participants
n=41 Participants
|
68 participants
n=85 Participants
|
|
Number of previous chemotherapies
2
|
10 participants
n=44 Participants
|
2 participants
n=41 Participants
|
12 participants
n=85 Participants
|
|
Number of previous chemotherapies
3
|
1 participants
n=44 Participants
|
3 participants
n=41 Participants
|
4 participants
n=85 Participants
|
|
Number of previous chemotherapies
7
|
1 participants
n=44 Participants
|
0 participants
n=41 Participants
|
1 participants
n=85 Participants
|
|
Number of relapses after previous therapy
1
|
32 participants
n=44 Participants
|
35 participants
n=41 Participants
|
67 participants
n=85 Participants
|
|
Number of relapses after previous therapy
2
|
9 participants
n=44 Participants
|
3 participants
n=41 Participants
|
12 participants
n=85 Participants
|
|
Number of relapses after previous therapy
3
|
2 participants
n=44 Participants
|
3 participants
n=41 Participants
|
5 participants
n=85 Participants
|
|
Number of relapses after previous therapy
7
|
1 participants
n=44 Participants
|
0 participants
n=41 Participants
|
1 participants
n=85 Participants
|
|
Patient received at least one maintenance therapy with PARPi
|
10 participants
n=44 Participants
|
4 participants
n=41 Participants
|
14 participants
n=85 Participants
|
|
BRCA mutation
YES
|
5 participants
n=44 Participants
|
4 participants
n=41 Participants
|
9 participants
n=85 Participants
|
|
BRCA mutation
NO
|
15 participants
n=44 Participants
|
17 participants
n=41 Participants
|
32 participants
n=85 Participants
|
|
BRCA mutation
Missing
|
24 participants
n=44 Participants
|
20 participants
n=41 Participants
|
44 participants
n=85 Participants
|
PRIMARY outcome
Timeframe: 12 month (from baseline to end of treatment)Population: Five patients were excluded from the PP (per protocol) population due to violation of inclusion criteria.
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.
Outcome measures
| Measure |
Arm A
n=42 Participants
PLD followed by Trabectedin. Treatment is repeated every 3 weeks for 6 cycles or until disease progression.
Trabectidin (Yondelis): To compare QoL in patients treated with trabectedin/PLD vs. other standard combination therapy of carboplatin/ PLD, carboplatin/ gemcitabine, or carboplatin/ paclitaxel
|
Arm B
n=38 Participants
* 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.
Trabectidin (Yondelis): To compare QoL in patients treated with trabectedin/PLD vs. other standard combination therapy of carboplatin/ PLD, carboplatin/ gemcitabine, or carboplatin/ paclitaxel
|
|---|---|---|
|
Difference in Quality of Life (QoL)
TOI at randomization (baseline)
|
31.1 units on a scale
Standard Deviation 15.6
|
28.7 units on a scale
Standard Deviation 14.7
|
|
Difference in Quality of Life (QoL)
TOI at EOT
|
36.9 units on a scale
Standard Deviation 18.1
|
34.4 units on a scale
Standard Deviation 16.6
|
|
Difference in Quality of Life (QoL)
Difference TOI: randomization over EOT
|
6.5 units on a scale
Standard Deviation 12.8
|
5.5 units on a scale
Standard Deviation 12.7
|
SECONDARY outcome
Timeframe: 18 monthProgression-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.
Outcome measures
| Measure |
Arm A
n=44 Participants
PLD followed by Trabectedin. Treatment is repeated every 3 weeks for 6 cycles or until disease progression.
Trabectidin (Yondelis): To compare QoL in patients treated with trabectedin/PLD vs. other standard combination therapy of carboplatin/ PLD, carboplatin/ gemcitabine, or carboplatin/ paclitaxel
|
Arm B
n=41 Participants
* 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.
Trabectidin (Yondelis): To compare QoL in patients treated with trabectedin/PLD vs. other standard combination therapy of carboplatin/ PLD, carboplatin/ gemcitabine, or carboplatin/ paclitaxel
|
|---|---|---|
|
Progression-free Survival
|
8.2 months
Interval 5.8 to 11.2
|
11 months
Interval 9.0 to 13.6
|
SECONDARY outcome
Timeframe: through study completion, up to 3 yearsOverall survival was defined as time from randomization until date of death to any cause.
Outcome measures
| Measure |
Arm A
n=44 Participants
PLD followed by Trabectedin. Treatment is repeated every 3 weeks for 6 cycles or until disease progression.
Trabectidin (Yondelis): To compare QoL in patients treated with trabectedin/PLD vs. other standard combination therapy of carboplatin/ PLD, carboplatin/ gemcitabine, or carboplatin/ paclitaxel
|
Arm B
n=41 Participants
* 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.
Trabectidin (Yondelis): To compare QoL in patients treated with trabectedin/PLD vs. other standard combination therapy of carboplatin/ PLD, carboplatin/ gemcitabine, or carboplatin/ paclitaxel
|
|---|---|---|
|
Overall Survival
|
14.9 months
Interval 10.4 to 35.2
|
19.9 months
Interval 11.2 to 30.7
|
Adverse Events
Arm A
Serious events: 20 serious events
Other events: 40 other events
Deaths: 40 deaths
Arm B
Serious events: 17 serious events
Other events: 41 other events
Deaths: 38 deaths
Serious adverse events
| Measure |
Arm A
n=44 participants at risk
PLD followed by Trabectedin. Treatment is repeated every 3 weeks for 6 cycles or until disease progression.
Trabectidin (Yondelis): To compare QoL in patients treated with trabectedin/PLD vs. other standard combination therapy of carboplatin/ PLD, carboplatin/ gemcitabine, or carboplatin/ paclitaxel
|
Arm B
n=41 participants at risk
* 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.
Trabectidin (Yondelis): To compare QoL in patients treated with trabectedin/PLD vs. other standard combination therapy of carboplatin/ PLD, carboplatin/ gemcitabine, or carboplatin/ paclitaxel
|
|---|---|---|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
6.8%
3/44 • through study completion, up to 3 years
|
4.9%
2/41 • through study completion, up to 3 years
|
|
General disorders
Ascites
|
0.00%
0/44 • through study completion, up to 3 years
|
9.8%
4/41 • through study completion, up to 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
4.5%
2/44 • through study completion, up to 3 years
|
2.4%
1/41 • through study completion, up to 3 years
|
|
General disorders
Sepsis
|
4.5%
2/44 • through study completion, up to 3 years
|
0.00%
0/41 • through study completion, up to 3 years
|
|
Gastrointestinal disorders
Ileus
|
9.1%
4/44 • through study completion, up to 3 years
|
4.9%
2/41 • through study completion, up to 3 years
|
|
Blood and lymphatic system disorders
Platelet count decrease
|
4.5%
2/44 • through study completion, up to 3 years
|
4.9%
2/41 • through study completion, up to 3 years
|
|
General disorders
Worsening of general condition
|
4.5%
2/44 • through study completion, up to 3 years
|
2.4%
1/41 • through study completion, up to 3 years
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/44 • through study completion, up to 3 years
|
2.4%
1/41 • through study completion, up to 3 years
|
|
General disorders
Thromboembolic event
|
0.00%
0/44 • through study completion, up to 3 years
|
2.4%
1/41 • through study completion, up to 3 years
|
|
General disorders
g-GT increased
|
2.3%
1/44 • through study completion, up to 3 years
|
0.00%
0/41 • through study completion, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.3%
1/44 • through study completion, up to 3 years
|
0.00%
0/41 • through study completion, up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoe
|
2.3%
1/44 • through study completion, up to 3 years
|
2.4%
1/41 • through study completion, up to 3 years
|
|
General disorders
Abdominal pain
|
0.00%
0/44 • through study completion, up to 3 years
|
2.4%
1/41 • through study completion, up to 3 years
|
|
Blood and lymphatic system disorders
Anemia grade 2
|
0.00%
0/44 • through study completion, up to 3 years
|
2.4%
1/41 • through study completion, up to 3 years
|
|
Infections and infestations
Catheter related infection
|
0.00%
0/44 • through study completion, up to 3 years
|
2.4%
1/41 • through study completion, up to 3 years
|
|
General disorders
Hematoma
|
2.3%
1/44 • through study completion, up to 3 years
|
0.00%
0/41 • through study completion, up to 3 years
|
|
General disorders
Poor general condition
|
2.3%
1/44 • through study completion, up to 3 years
|
0.00%
0/41 • through study completion, up to 3 years
|
Other adverse events
| Measure |
Arm A
n=44 participants at risk
PLD followed by Trabectedin. Treatment is repeated every 3 weeks for 6 cycles or until disease progression.
Trabectidin (Yondelis): To compare QoL in patients treated with trabectedin/PLD vs. other standard combination therapy of carboplatin/ PLD, carboplatin/ gemcitabine, or carboplatin/ paclitaxel
|
Arm B
n=41 participants at risk
* 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.
Trabectidin (Yondelis): To compare QoL in patients treated with trabectedin/PLD vs. other standard combination therapy of carboplatin/ PLD, carboplatin/ gemcitabine, or carboplatin/ paclitaxel
|
|---|---|---|
|
Blood and lymphatic system disorders
Hypokalemia
|
9.1%
4/44 • through study completion, up to 3 years
|
0.00%
0/41 • through study completion, up to 3 years
|
|
General disorders
Myalgia
|
9.1%
4/44 • through study completion, up to 3 years
|
7.3%
3/41 • through study completion, up to 3 years
|
|
Gastrointestinal disorders
Vomiting
|
22.7%
10/44 • through study completion, up to 3 years
|
14.6%
6/41 • through study completion, up to 3 years
|
|
General disorders
Weight loss
|
4.5%
2/44 • through study completion, up to 3 years
|
0.00%
0/41 • through study completion, up to 3 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
20.5%
9/44 • through study completion, up to 3 years
|
26.8%
11/41 • through study completion, up to 3 years
|
|
General disorders
Insomnia
|
11.4%
5/44 • through study completion, up to 3 years
|
19.5%
8/41 • through study completion, up to 3 years
|
|
General disorders
Hot flashes
|
6.8%
3/44 • through study completion, up to 3 years
|
17.1%
7/41 • through study completion, up to 3 years
|
|
General disorders
Stomach pain
|
0.00%
0/44 • through study completion, up to 3 years
|
4.9%
2/41 • through study completion, up to 3 years
|
|
General disorders
Dry skin
|
6.8%
3/44 • through study completion, up to 3 years
|
9.8%
4/41 • through study completion, up to 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place