Clinical trial · Interventional
Superiority Trial Evaluating Digitalized Information Media for Patients With Advanced Sarcomas Receiving Systemic 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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
ePPS-2202 is a study designed to evaluate the benefits of a dematerialised personalised care plan (PCP) compared to standard information/PCP for patients with advanced sarcomas receiving systemic treatment. Participants will be randomised to an experimental group or a control group. Patients in the experimental group will receive the dematerialised PCP in addition to the standard PCP while patients in the control group will receive the standard PCP alone. All patients will be followed until the end of second-line treatment, the start of a new line of treatment, or until the 24-month follow-up.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Soft Tissue Sarcoma | Soft Tissue Sarcoma | CURATED_BROADER | 0.78 |
| Sarcoma Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dematerialized Personalized Care Plan (ePCP) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control group : standard PCP
- description
- Patient will receive standard support PCP
- type
- EXPERIMENTAL
- label
- Experimental group : demateralized PCP
- description
- Patient will receive standard support PCP and dematerialized PCP (ePCP)
- interventionNames
- Other: Dematerialized Personalized Care Plan (ePCP)
Primary outcomes (1)
- measure
- Severe toxicity in the first 3 months of treatment
- timeFrame
- 3 months
- description
- Severe toxicity will be assessed through the reporting of adverse events (AE). Will be considered as an AE all indesirable medical event regardless of the cause, occurring between randomisation and the end of treatment + 30days or the start of a new systemic anti-cancer treatment or the 24-month follow-up. All AE grade ≥ 3 according to Common Terminology Criteria for Adverse Events v5.0 scale (NCI-CTCAE) will be considered severe.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available