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JOURNAL ONKOLOGIE – STUDIE
PROTraSarc

Prospective Study to Evaluate Patient Reported Outcomes (PRO) During Rechallenge With Trabectedin in Sarcoma Patients

Rekrutierend

NCT-Nummer:
NCT06050434

Studienbeginn:
Oktober 2023

Letztes Update:
18.11.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Sarcoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Collaborator:
PharmaMar

Studienleiter

Markus Schuler, PD Dr. med.
Principal Investigator
Onkologischer Schwerpunkt Oskar-Helene-Heim, Clinic and Polyclinic for Internal Medicine I, University Hospital Carl Gustav Carus, TU Dresden, Dresden, Germany
Daniel Pink, PD Dr. med.
Principal Investigator
Sarcoma Center Berlin-Brandenburg, Helios Hospital Bad Saarow, Department of Internal Medicine C, University Hospital Greifswald, Germany
Salah-Eddin Al-Batran, Prof. Dr. med.
Study Director
Institut für Klinische Krebsforschung am Krankenhaus Nordwest

Kontakt

Markus Schuler, PD Dr. med.
Kontakt:
Phone: +49 (0)3064499
Phone (ext.): 5230
E-Mail: markus.schuler@onkologie-ohh.de» Kontaktdaten anzeigen

Studienlocations
(3 von 9)

Interdisziplinäres Brustzentrum der Universitätsmedizin Greifswald
Ferdinand-Sauerbruch-Straße
17475 Greifswald Greifswald
(Mecklenburg-Vorpommern)
DeutschlandRekrutierend» Google-Maps
Ansprechpartner:
Christian Schmidt, Prof.» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

Detailed Description:

Chemotherapy with Trabectedin is an effective treatment for sarcoma patients in the second

line setting or in first line for patients who are deemed unsuitable to receive anthracycline

therapy. Several features differentiate its clinical performance from other chemotherapeutic

agents, including durability of response and the absence of cumulative toxicity even upon

re-exposition to treatment after interruption of therapy. In addition, the results of the

T-Dis trial evaluating the impact of Trabectedin rechallenge demonstrated that it retains its

activity when patients are rechallenged on progression after a treatment break.

Since sarcoma patient usually report a worse global quality of life (QoL) compared to the

general population, one of the main goals of treating advanced-stage patients with

Trabectedin, in addition to its efficacy, is to improve the QoL, represented by symptom

control and other patient-related outcomes. However, little is known to date about the QoL

during a rechallenge with Trabectedin, after patients had to discontinue Trabectedin

treatment.

Patient-reported outcome (PRO) measures are standardized questionnaires that collect

information on health outcomes directly from the patients, including symptoms, health-related

QoL parameters and functional status. In general, there are two types of PROMs,

disease-specific and general measures that can also be used for healthy populations. A

growing number of articles supports the need for, as well as the benefit of, deriving

information directly from patients. Thus, the application of PRO measures, initially

developed for the use in research, has become more common nowadays and their application is

included in supporting clinical decision making, comparing outcomes among health-care

providers, stimulating quality improvement and evaluating practices and policies. Therefore,

the collection of real-world data from patients subject to Trabectedin rechallenge would

enable further estimations on the feasibility and efficacy of Trabectedin rechallenge.

The prospective PROTraSarc sub-study will primarily investigate the PRO of Trabectedin

rechallenge in patients with soft tissue sarcomas that had to discontinue initial Trabectedin

treatment due to various reasons such as progression, side effects or surgery, as is commonly

the case in real-life settings. Embedding this trial in the GISAR registry enables the

evaluation of a large number of patients with long-term follow-up which allows multiple

analyses regarding different questions that remain unanswered until today.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Enrolled participant of the GISAR registry and their sub-studies

- Patient with histologically confirmed soft tissue sarcomas

- Pretreatment with Trabectedin, termination of this therapy regardless of reason

- Planned rechallenge or started rechallenge with Trabectedin in any line of therapy

within 2 weeks before inclusion

- Interval between last Trabectedin treatment and Trabectedin rechallenge at least 3

months

Exclusion Criteria:

- Not able to understand all implications of study participation

- No written informed consent

- Age ≤ 18 years

Studien-Rationale

Primary outcome:

1. Patient reported outcome regarding symptoms and side effects during Trabectedin re-challenge in soft tissue sarcoma patients (Time Frame - through study completion, an average of 2 years):
PRO-CTCAE questionnaire

2. Patient reported outcome regarding distress during Trabectedin re-challenge in soft tissue sarcoma patients (Time Frame - through study completion, an average of 2 years):
Distress-Thermometer

3. Patient reported outcome regarding quality of life during Trabectedin re-challenge in soft tissue sarcoma patients (Time Frame - through study completion, an average of 2 years):
QLQ-C30 Questionnaire

4. Patient reported outcome regarding cancer behaviour inventory (Time Frame - every nine to 18 weeks during Trabectedin re-challenge, every 3 Month in follow up):
CBI-B Questionnaire

5. Patient reported outcome measuring anxiety and depression (Time Frame - through study completion, an average of 2 years):
PHQ-4 Questionnaire

6. Patient reported outcome measuring self-efficacy for managing chronic disease (Time Frame - through study completion, an average of 2 years):
SES6G Questionnaire

Secondary outcome:

1. Analysis of correlation of PROs with clinical parameters (Time Frame - through study completion, an average of 2 years):
Evaluation of different PROs and analysis of correlation with clinical parameters, e.g. therapy response and side effects experienced during therapy

2. Characterization of patients receiving Trabectedin rechallenge in real life setting (Time Frame - through study completion, an average of 2 years):
Characterization of patients receiving Trabectedin rechallenge in real life setting, e.g. demographics, previous therapies

3. Characterization of Trabectedin rechallenge in real life conditions (Time Frame - through study completion, an average of 2 years):
Characterization of Trabectedin rechallenge in real life conditions, e.g. number of Trabectedin cycles applied, response to therapy, reason for end of Trabectedin rechallenge (e.g. disease progression, intolerable toxicity, death)

Quelle: ClinicalTrials.gov


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