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Quality of LifePhase 4COMPASSNCT03164980

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

A Phase 4 study testing Trabectidin (Yondelis) in people with Quality of Life and Ovarian Cancer, run by North Eastern German Society of Gynaecological Oncology at 21 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Trabectidin (Yondelis)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
89 participants
Where
21 sitesGermany
Study dates
1 Feb 2018to 8 Aug 2023
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Women aged ≥ 18 years
  • Patients with histologically confirmed diagnosis of epithelial ovarian cancer, primary peritoneal carcinoma or fallopian tube cancer who received ≥1 prior chemotherapy
  • Patients must be eligible for platin-containing therapy; Patient is defined as platin-sensitive when considered for platin-containing therapy by the investigator. The time frame from end of prior therapy until disease progression alone is not pivotal for study participation. Patients without a platin-containing regimen in the previous line who are also eligible for platin-containing regime are also appropriate for participation
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
  • Adequate baseline organ function as defined as
  • Leucocytes > 3.0 x 109/l
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  • Platelet count > 100 x 109/l
  • Absolute neutrophil count (ANC) ≥1500/mm3
  • Haemoglobin ≥ 9 g/dl
  • Alkaline Phosphatase (AP) ≤ 2.5 × ULN (consider hepatic isoenzymes 5 nucleotidase or gamma glutamyl transpeptidase (GGT), if the elevation could be osseous in origin)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN
  • Creatinine-Clearance ≥ 60 ml/min (MDRD formula or Cockroft \& Gault formula)
  • Serum creatinine ≤ 1.5 mg/dl
  • Creatine phosphokinase (CPK) ≤ 2.5 × ULN
  • Total bilirubin < ULN
  • Women of childbearing potential should use contraceptives or abstain from heterosexual activity for the course of the study through 6 months after the last dose of study medication or be surgically sterile.
  • Adequate cardiac function defined as left ventricular ejection fraction (LVEF) ≥ 50% as determined by echocardiogram
  • Patients must provide written informed consent prior to performance of study specific procedures or assessments, and must be willing to comply with treatment and follow up assessments and procedures.

Who cannot join

  • Only malignancies, which influence the prognosis
  • Any unstable or serious concurrent condition (e.g. active infection requiring systemic therapy).
  • Chemotherapy or radiation therapy or tumor embolization within 2 weeks prior to the first dose of study drug or planned during study participation.
  • Patients who have refractory disease. Refractory disease is defined if relapse occurs <4 months after beginning of platin-containing therapy.
  • Hypersensitivity to the active substance or to any of the excipients of study drug
  • Findings from ECG and/or assessment of LVEF which indicate an anthracycline-related cardiotoxic process which contradicts administration of liposomal doxorubicin in accordance with the requirements of the SmPC of PLD.
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  • Biological therapy, immunotherapy, hormonal therapy or treatment with an investigational agent within 14 days (for bevacizumab, 30 days) prior to the first dose of study drug.
  • Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
  • Participation in another clinical study with experimental therapy within the 30 days before start of and during treatment. Participation in a non-interventional study should be discussed with sponsor and NC beforehand.
  • Patients in a closed institution according to an authority or court decision (AMG § 40, Abs. 1 No. 4)
  • Patients who are depending on the sponsor/CRO or investigational site as well as on the investigator.
  • Pregnancy or lactation period, or planning to become pregnant within 7 months after the end of treatment.

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

Germany21 sites

  • Universitätsklinikum Aachen

    Aachen, 52074

  • Sankt Gertrauden-Krankenhaus

    Berlin, 10713

  • Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum

    Berlin, 13353

  • Praxis Krebsheilkunde für Frauen

    Berlin, 13597

  • Medizinisches Zentrum Bonn Friedensplatz

    Bonn, 53111

  • Universitätsklinikum Brandenburg an der Havel

    Brandenburg an der Havel, 14770

  • Studien GbR Braunschweig

    Braunschweig, 38100

  • Städtisches Klinikum Dessau

    Dessau, 06847

  • Frauenklinik Carl Gustav Carus

    Dresden, 01307

  • Onkologische Schwerpunktpraxis

    Dresden, 01307

  • Krankenhaus Nordwest gGmbH

    Frankfurt, 60488

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • ZAGO am Helios Klinikum Krefeld

    Krefeld, 47805

  • Universitätsfrauenklinik Leipzig

    Leipzig, 04103

  • Universitätsklinik der Johannes Gutenberg-Universität Mainz

    Mainz, 55131

  • Ruppiner Kliniken GmbH

    Neuruppin, 16816

  • Sana Klinikum Offenbach

    Offenbach, 63069

  • Klinikum Südstadt Rostock

    Rostock, 18059

  • Caritas Klinikum St. Theresia

    Saarbrücken, 66113

  • Krankenhaus Saarlouis vom DRK

    Saarlouis, 66740

  • Christliches Klinikum Unna gGmbH

    Unna, 59423

Other trials in Germany

About this study

Official title: 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

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.

Read the 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.

Being tested
Trabectidin (Yondelis)
Keywords
Quality of life, ovarian cancer, platinum sensitive, recurrent
Medical subject headings
Ovarian Neoplasms, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trabectidin (Yondelis)Drug

    To compare QoL in patients treated with trabectedin/PLD vs. other standard combination therapy of carboplatin/ PLD, carboplatin/ gemcitabine, or carboplatin/ paclitaxel

Study groups in NCT03164980
Study groupRoleWhat they receive
Arm AExperimentalPLD followed by Trabectedin. Treatment is repeated every 3 weeks for 6 cycles or until disease progression.
Receives: Drug: Trabectidin (Yondelis)
Arm BExperimental* 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.
Receives: Drug: Trabectidin (Yondelis)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 month (from baseline to end of treatment)

Secondary outcomes (2)

  1. 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.

    Measured: 18 month

  2. Overall Survival

    Overall survival was defined as time from randomization until date of death to any cause.

    Measured: through study completion, up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2017
  2. Study start1 Feb 2018
  3. Primary completion8 Aug 2023
  4. Study completion8 Aug 2023

Why it stopped: 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
89 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03164980
Sponsor's protocol ID
NOGGO S16/COMPASS
Acronym
COMPASS
Status last verified
Mar 2025
First submitted
18 May 2017
Last updated
20 Mar 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Trabectidin (Yondelis) in people with Quality of Life and Ovarian Cancer, run by North Eastern German Society of Gynaecological Oncology at 21 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in Quality of Life (QoL) (time frame: 12 month (from baseline to end of treatment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03164980.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.

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