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

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ClinicalTrials.gov Identifier: NCT06050434
Recruitment Status : Recruiting
First Posted : September 22, 2023
Last Update Posted : November 18, 2023
Sponsor:
Collaborator:
PharmaMar
Information provided by (Responsible Party):
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

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.

Condition or disease
Soft Tissue Sarcoma

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: PROTraSarc Prospective Study to Evaluate Patient Reported Outcomes (PRO) During Rechallenge With Trabectedin in Sarcoma Patients - A GISAR Sub-study
Actual Study Start Date : October 31, 2023
Estimated Primary Completion Date : May 2, 2025
Estimated Study Completion Date : December 1, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Trabectedin

Group/Cohort
Trabectedin Rechallenge in Soft sarcoma patients
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.



Primary Outcome Measures :
  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 Measures :
  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)


Other Outcome Measures:
  1. Assessment of PRO data capture via an electronic tool (ePRO) [ Time Frame: through study completion, an average of 2 years ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06050434


Contacts
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Contact: Markus Schuler, PD Dr. med. +49 (0)3064499 ext 5230 markus.schuler@onkologie-ohh.de
Contact: Clara Dreyling +49 (0)69 7601 ext 4755 gisar@ikf-khnw.de

Locations
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Germany
HELIOS KLinikum Bad Saarow Recruiting
Bad Saarow, Germany
Contact: Daniel Pink, Dr.         
HELIOS Klinikum Berlin Buch Not yet recruiting
Berlin, Germany
Contact: Peter Reichardt         
Frankfurt Universitätsklinikum Not yet recruiting
Frankfurt/Main, Germany
Contact: Marit Ahrens         
Universitätsmedizin Greifswald Recruiting
Greifswald, Germany
Contact: Christian Schmidt, Prof.         
Universitätsmedizin Göttingen Not yet recruiting
Göttingen, Germany
Contact: Florian Bösch, Dr.         
Uniklinikum Leipzig Not yet recruiting
Leipzig, Germany
Contact: Anne-Marie Scheuble, Dr.         
Universitätsmedizin Mainz Recruiting
Mainz, Germany
Contact: Marius Fried, Dr.         
Westfälische Wilhelms-Universität Münster Not yet recruiting
Münster, Germany
Contact: Torsten Kessler, Dr.         
Universitätsklinikum Tübingen Not yet recruiting
Tübingen, Germany
Contact: Christoph Deinzer, Dr.         
Sponsors and Collaborators
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
PharmaMar
Investigators
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Principal Investigator: Markus Schuler, PD Dr. med. Onkologischer Schwerpunkt Oskar-Helene-Heim, Clinic and Polyclinic for Internal Medicine I, University Hospital Carl Gustav Carus, TU Dresden, Dresden, Germany
Principal Investigator: Daniel Pink, PD Dr. med. Sarcoma Center Berlin-Brandenburg, Helios Hospital Bad Saarow, Department of Internal Medicine C, University Hospital Greifswald, Germany
Study Director: Salah-Eddin Al-Batran, Prof. Dr. med. Institut für Klinische Krebsforschung am Krankenhaus Nordwest
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Responsible Party: Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
ClinicalTrials.gov Identifier: NCT06050434    
Other Study ID Numbers: PROTraSarc
First Posted: September 22, 2023    Key Record Dates
Last Update Posted: November 18, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: will not be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest:
Re-Challenge
Trabectedin
Sarcoma
registry
PRO
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms