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

NCT06050434 | Terminated

• 1 other identifier: PROTraSarc
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 9

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.

Conditions

Soft Tissue Sarcoma

Keywords

Re-Challenge; Trabectedin; Sarcoma; registry; PRO

Outcome Measures

Primary Outcomes (6)

• 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

• Patient reported outcome regarding distress during Trabectedin re-challenge in soft tissue sarcoma patients

  Distress-Thermometer

  through study completion, an average of 2 years

• 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

• 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

• Patient reported outcome measuring anxiety and depression

  PHQ-4 Questionnaire

  through study completion, an average of 2 years

• Patient reported outcome measuring self-efficacy for managing chronic disease

  SES6G Questionnaire

  through study completion, an average of 2 years

Secondary Outcomes (3)

• Analysis of correlation of PROs with clinical parameters

  through study completion, an average of 2 years

• Characterization of patients receiving Trabectedin rechallenge in real life setting

  through study completion, an average of 2 years

• Characterization of Trabectedin rechallenge in real life conditions

  through study completion, an average of 2 years

Other Outcomes (1)

• Assessment of PRO data capture via an electronic tool (ePRO)

  through study completion, an average of 2 years

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• Interval between last Trabectedin treatment and Trabectedin rechallenge at least 3 months

You may not qualify if:

• Not able to understand all implications of study participation
• No written informed consent
• Age ≤ 18 years

Sponsors & Collaborators

• Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest: lead
• PharmaMar: collaborator

Study Sites (9)

HELIOS KLinikum Bad Saarow

Bad Saarow, Germany

Location

HELIOS Klinikum Berlin Buch

Berlin, Germany

Location

Frankfurt Universitätsklinikum

Frankfurt am Main, Germany

Location

Universitätsmedizin Göttingen

Göttingen, Germany

Location

Universitätsmedizin Greifswald

Greifswald, Germany

Location

Uniklinikum Leipzig

Leipzig, Germany

Location

Universitätsmedizin Mainz

Mainz, Germany

Location

Westfälische Wilhelms-Universität Münster

Münster, Germany

Location

Universitätsklinikum Tübingen

Tübingen, Germany

Location

MeSH Terms

Conditions

Sarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Salah-Eddin Al-Batran, Prof. Dr. med.

  Institut für Klinische Krebsforschung am Krankenhaus Nordwest

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: September 22, 2023
• Study Start: October 31, 2023
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (9)