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

Soft Tissue Sarcoma Clinical Trial

— PROTraSarc  

Official title:

PROTraSarc Prospective Study to Evaluate Patient Reported Outcomes (PRO) During Rechallenge With Trabectedin in Sarcoma Patients - A GISAR Sub-study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06050434
• Other study ID #: PROTraSarc
• Status: Recruiting
• Start date: October 31, 2023
• Est. completion date: December 1, 2025

Study information

• Verified date: November 2023
• Source: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
• Contact: Markus Schuler, PD Dr. med.
• Phone: +49 (0)3064499
• Email: markus.schuler[@]onkologie-ohh.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2025
• Est. primary completion date: May 2, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcoma
• Soft Tissue Sarcoma

Locations

Country	Name	City	State
Germany	HELIOS KLinikum Bad Saarow	Bad Saarow
Germany	HELIOS Klinikum Berlin Buch	Berlin
Germany	Frankfurt Universitätsklinikum	Frankfurt/Main
Germany	Universitätsmedizin Göttingen	Göttingen
Germany	Universitätsmedizin Greifswald	Greifswald
Germany	Uniklinikum Leipzig	Leipzig
Germany	Universitätsmedizin Mainz	Mainz
Germany	Westfälische Wilhelms-Universität Münster	Münster
Germany	Universitätsklinikum Tübingen	Tübingen

Sponsors (2)

Lead Sponsor	Collaborator
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest	PharmaMar

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assessment of PRO data capture via an electronic tool (ePRO)	Assessment of PRO data capture via an electronic tool (ePRO), e.g. handling, user experience, completion rate, adherence) and its implementation into the routine sarcoma patient care (parameters will e.g. include patient acceptance, represented by the rate of patients entering an ePRO tool at least once) for sarcoma patients under Trabectedin rechallenge	through study completion, an average of 2 years
Primary	Patient reported outcome regarding symptoms and side effects during Trabectedin re-challenge in soft tissue sarcoma patients	PRO-CTCAE questionnaire	through study completion, an average of 2 years
Primary	Patient reported outcome regarding distress during Trabectedin re-challenge in soft tissue sarcoma patients	Distress-Thermometer	through study completion, an average of 2 years
Primary	Patient reported outcome regarding quality of life during Trabectedin re-challenge in soft tissue sarcoma patients	QLQ-C30 Questionnaire	through study completion, an average of 2 years
Primary	Patient reported outcome regarding cancer behaviour inventory	CBI-B Questionnaire	every nine to 18 weeks during Trabectedin re-challenge, every 3 Month in follow up
Primary	Patient reported outcome measuring anxiety and depression	PHQ-4 Questionnaire	through study completion, an average of 2 years
Primary	Patient reported outcome measuring self-efficacy for managing chronic disease	SES6G Questionnaire	through study completion, an average of 2 years
Secondary	Analysis of correlation of PROs with clinical parameters	Evaluation of different PROs and analysis of correlation with clinical parameters, e.g. therapy response and side effects experienced during therapy	through study completion, an average of 2 years
Secondary	Characterization of patients receiving Trabectedin rechallenge in real life setting	Characterization of patients receiving Trabectedin rechallenge in real life setting, e.g. demographics, previous therapies	through study completion, an average of 2 years
Secondary	Characterization of Trabectedin rechallenge in real life conditions	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)	through study completion, an average of 2 years