Phase 3 Superiority Trial Evaluating the Benefit of Dematerialized Information Media for Patients With Advanced Sarcomas Receiving Systemic Treatment for Metastatic or Locally Advanced Disease.

What this Trial Is About

This research investigates the benefits of a digital personalized care plan (PCP) compared to the standard PCP for patients with advanced sarcomas receiving systemic treatment. The study focuses on patients with metastatic or locally advanced soft tissue or visceral sarcomas who are treated with specific monotherapies such as pazopanib, trabectedine, eribulin, ifosfamide, or dacarbazine. The trial is a phase 3, randomized, open-label, controlled, multicenter study assessing the impact of these care plans on patient outcomes. Participants are randomly assigned to one of two groups. The experimental group receives both the standard PCP and a dematerialized (digital) personalized care plan, while the control group receives only the standard PCP. Patients continue treatment and follow-up until the end of second-line treatment, the start of a new treatment line, or up to 24 months. The main goal is to compare the occurrence of severe adverse events during the first three months of second-line treatment between the two groups. Throughout the study, participants will be monitored for severe toxicity, progression-free survival, overall survival, types of severe adverse events, hospitalizations due to adverse events, and quality of life using a specific questionnaire. Data collection continues for up to 24 months, with particular focus on the first three months of second-line therapy. This monitoring ensures careful evaluation of patient safety, treatment effects, and quality of life during the study period.

Superiority Trial Evaluating Digitalized Information Media for Patients With Advanced Sarcomas Receiving Systemic Treatment.