Superiority Trial Evaluating Digitalized Information Media for Patients With Advanced Sarcomas Receiving Systemic Treatment.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dematerialized Personalized Care Plan (ePCP).
- Who it may be relevant to
- Registry conditions: Sarcoma Metastatic, Locally Advanced Soft Tissue Sarcoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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.
Overview
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.
Detailed description
ePPS-2202 is a phase 3, randomised,open-label, controlled, multicentre interventional study, designed to evaluate the benefits of a dematerialised personalised care plan (PCP) compared to standard information/PCP in patients with metastatic of locally advanced sarcomas with indication of a systemic treatment with pazopanib, tracbectedine, eribuline, ifosfamide or dacarbazine monotherapy.
Participants will be randomised to the experimental arm or the control arm. Patients in the experimental arm will receive the dematerialised PCP in addition to the standard PCP while patients in the control arm 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.
The main analysis will compare the proportion of patients in each arm who experience at least one severe adverse event during the first 3 months of second-line treatment. Adverse events will be considered severe if they are graded 3 or higher according to NCI-CTCAE v5.0.
Interventions
- Other Dematerialized Personalized Care Plan (ePCP)
Post-treatment support with standard support combined with dematerialized support
Primary outcome measures
- Severe toxicity in the first 3 months of treatment [Time frame: 3 months]
Secondary outcome measures (7)
- Progression-free survival (PFS) [Time frame: 24 months]
- Overall survival (OS) [Time frame: 24 months]
- Severe toxicity [Time frame: 24 months]
- Nature of severe AEs [Time frame: 24 months]
- AEs leading to hospitalization [Time frame: 24 months]
- Survival weighted by quality of life [Time frame: 24 months]
- Quality of life assessed by EORTC QLQ-C30 questionnaire [Time frame: 3 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
France · 11 centers
- Centre Léon Bérard — Lyon
- CHU Jean Minjoz — Besançon
- Centre Eugène Marquis — Rennes
- Centre Paul Strauss — Strasbourg
- Centre Oscar Lambret — Lille
- CHU de Poitiers — Poitiers
- Institut Claudius Regaud — Toulouse
- Institut de Cancérologie de l'Ouest — Saint-Herblain
- … and 3 more centers
Identifiers
NCT: NCT06211257 · ePPS-2202 · 2023-A00984-41