Evaluating a digital care plan for patients with advanced sarcomas on second-line treatment

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.

This study is testing if a new digital care plan can help people with advanced sarcomas on second-line treatment have fewer severe side effects compared to the usual care they receive.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 377 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Oscar Lambret (other)
• Locations: 11 sites (Lyon, Auvergne-Rhône-Alpes and 10 other locations)
• Trial ID: NCT06211257 on ClinicalTrials.gov

What this trial studies

This study aims to assess the effectiveness of a dematerialised personalised care plan (PCP) compared to standard care for patients with advanced sarcomas receiving second-line treatment. Participants will be randomly assigned to either an experimental group, which receives the dematerialised PCP alongside standard care, or a control group that receives only the standard PCP. The study will monitor patients until the end of their second-line treatment, the initiation of a new treatment, or a follow-up period of 24 months. The primary outcome will focus on the incidence of severe adverse events during the first three months of treatment.

Who should consider this trial

Good fit: Ideal candidates include patients with inoperable metastatic or locally advanced soft tissue sarcomas who are eligible for second-line treatment after failing first-line anthracycline therapy.

Not a fit: Patients who do not understand French or have difficulty accessing a computer may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance patient care and reduce severe adverse events in individuals with advanced sarcomas.

How similar studies have performed: While this approach is innovative, similar studies evaluating personalized care plans have shown promise in improving patient outcomes.

Eligibility criteria

Inclusion Criteria:

* Sarcomas of soft tissues or viscera ;
* Inoperable metastatic or locally advanced disease ;
* Indication for systemic treatment with pazopanib, trabectedine, eribulin, ifosfamide or dacarbazine monotherapy ;
* Patient covered by French social security ;
* Written, signed, informed consent ;

Exclusion Criteria:

* Prior inclusion in ePPS trial for a prior systemic treatment ;
* Poor understanding of French ;
* Difficulty accessing a computer ;
* Pregnant or nursing woman ;
* Person deprived of liberty or under guardianship ;
* Impossibility of undergoing medical follow-up for geographical, social or psychological reasons.

Where this trial is running

Lyon, Auvergne-Rhône-Alpes and 10 other locations

• Centre Léon Bérard — Lyon, Auvergne-Rhône-Alpes, France (RECRUITING)
• CHU Jean Minjoz — Besançon, Bourgogne-Franche-Comté, France (RECRUITING)
• Centre Eugène Marquis — Rennes, Brittany Region, France (NOT_YET_RECRUITING)
• Centre Paul Strauss — Strasbourg, Grand Est, France (RECRUITING)
• Centre Oscar Lambret — Lille, Hauts-de-France, France (RECRUITING)
• CHU de Poitiers — Poitiers, New Aquitaine, France (RECRUITING)
• Institut Claudius Regaud — Toulouse, Occitanie, France (WITHDRAWN)
• Institut de Cancérologie de l'Ouest — Saint-Herblain, Pays de la Loire Region, France (RECRUITING)
• Institut de Cancérologie de Lorraine — Vandœuvre-lès-Nancy, France (NOT_YET_RECRUITING)
• Hôpital Pitié-Salpêtrière AP-HP — Paris, Île-de-France Region, France (NOT_YET_RECRUITING)
• Gustave Roussy — Villejuif, Île-de-France Region, France (RECRUITING)

Study contacts

• Principal investigator: Diane PANNIER, MD — Centre Oscar Lambret
• Study coordinator: PANNIER Diane, DR

Conditions: Sarcoma Metastatic, Locally Advanced Soft Tissue Sarcoma, Sarcoma, Advanced, Dematerialised, Care, Plan