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.
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 ;
Prior inclusion in ePPS trial for a prior systemic treatment ;
Poor understanding of French ;
Difficulty accessing a computer ;
Pregnant or nursing woman ;
Parallel
Dematerialized Personalized Care Plan (ePCP)
Other interventionPost-treatment support with standard support combined with dematerialized support
Severe toxicity in the first 3 months of treatment
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.
Progression-free survival (PFS)
PFS will be defined as the time from randomisation to investigator-assessed disease progression (RECIST 1.1 or clinical). No progressive-patients will be censured at the 24-months follow-up.
Overall survival (OS)
OS will be defined as the time from randomisation to patient's death regardless of the cause. Alive patients will be censured at the 24-month follow-up.
Severe toxicity
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 relationship, occurring between randomization and the end of treatment + 30days or the stard of a new systemic anticancer 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.
Nature of severe AEs
Description of the nature of severe adverse events occuring between randomization and the end of treatment + 30days or the start of a new systemic anticancer treatment or the 24-month follow-up, especially: * Asthenia ; * Gastrointestinal disorders: vomiting, anorexia, mucositis/aphthosis, diarrhea, constipation; * Skin disorders: hand-foot syndrome, phototoxicity, dry skin skin dryness; * Hypertension; * Hematological toxicity ; * Hematuric cystitis with ifosfamide; * Ifosfamide encephalopathy; * Extravasation with trabectedine;
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Centre Oscar Lambret
Lead sponsor
Canceropôle Nord Ouest
Collaborator
