Clinical trial NCT06050434: Prospective Study to Evaluate Patient Reported Outcomes (PRO) During Rechallenge With Trabectedin in Sarcoma Patients
Official title: PROTraSarc Prospective Study to Evaluate Patient Reported Outcomes (PRO) During Rechallenge With Trabectedin in Sarcoma Patients - A GISAR Sub-study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Soft Tissue Sarcoma
Keywords: Re-Challenge
Trabectedin
Sarcoma
registry
PRO
Lead sponsor: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Sponsor class: OTHER
Collaborators: name: PharmaMar
First posted: 2023-09-22
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult GISAR participants with Trabectedin-pretreated soft tissue sarcomas and rechallenge with at least one cycle of Trabectedin in any line of therapy, with the interval between Trabectedin interruption and Trabectedin rechallenge being at least 3 months.

Brief summary: 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. The prospective 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient reported outcome regarding symptoms and side effects during Trabectedin re-challenge in soft tissue sarcoma patients
timeFrame: through study completion, an average of 2 years
measure: Patient reported outcome regarding distress during Trabectedin re-challenge in soft tissue sarcoma patients
timeFrame: through study completion, an average of 2 years
measure: Patient reported outcome regarding quality of life during Trabectedin re-challenge in soft tissue sarcoma patients
timeFrame: through study completion, an average of 2 years
measure: Patient reported outcome regarding cancer behaviour inventory
timeFrame: every nine to 18 weeks during Trabectedin re-challenge, every 3 Month in follow up
measure: Patient reported outcome measuring anxiety and depression
timeFrame: through study completion, an average of 2 years
measure: Patient reported outcome measuring self-efficacy for managing chronic disease
timeFrame: through study completion, an average of 2 years
Secondary outcomes:
measure: Analysis of correlation of PROs with clinical parameters
timeFrame: through study completion, an average of 2 years
measure: Characterization of patients receiving Trabectedin rechallenge in real life setting
timeFrame: through study completion, an average of 2 years
measure: Characterization of Trabectedin rechallenge in real life conditions
timeFrame: through study completion, an average of 2 years
Other outcomes:
measure: Assessment of PRO data capture via an electronic tool (ePRO)
timeFrame: through study completion, an average of 2 years
Locations:
city: Bad Saarow
country: Germany
facility: HELIOS KLinikum Bad Saarow
city: Berlin
country: Germany
facility: HELIOS Klinikum Berlin Buch
city: Frankfurt/Main
country: Germany
facility: Frankfurt Universitätsklinikum
city: Greifswald
country: Germany
facility: Universitätsmedizin Greifswald
city: Göttingen
country: Germany
facility: Universitätsmedizin Göttingen
city: Leipzig
country: Germany
facility: Uniklinikum Leipzig
city: Mainz
country: Germany
facility: Universitätsmedizin Mainz
city: Münster
country: Germany
facility: Westfälische Wilhelms-Universität Münster
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
Study officials:
affiliation: Onkologischer Schwerpunkt Oskar-Helene-Heim, Clinic and Polyclinic for Internal Medicine I, University Hospital Carl Gustav Carus, TU Dresden, Dresden, Germany
name: Markus Schuler, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Sarcoma Center Berlin-Brandenburg, Helios Hospital Bad Saarow, Department of Internal Medicine C, University Hospital Greifswald, Germany
name: Daniel Pink, PD Dr. med.
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut für Klinische Krebsforschung am Krankenhaus Nordwest
name: Salah-Eddin Al-Batran, Prof. Dr. med.
role: STUDY_DIRECTOR
References: