Clinical trial NCT06211257: Superiority Trial Evaluating Digitalized Information Media for Patients with Advanced Sarcomas Receiving Second Line Treatment.
Official title: Phase 3 Superiority Trial Evaluating the Benefit of Dematerialized Information Media for Patients with Advanced Sarcomas Receiving Second Line Treatment.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sarcoma Metastatic
Locally Advanced Soft Tissue Sarcoma
Keywords: Sarcoma
Advanced
Dematerialised
Care
Plan
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
Collaborators: name: Canceropôle Nord Ouest
First posted: 2024-01-18
Enrollment: 377
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized 1:1
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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 second-line 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 second-line treatment with pazopanib, tracbectedine, eribuline, ifosfamide or dacarbazine after failure of a first-line anthracycline-based regimen.

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.

Eligibility criteria: Inclusion Criteria:

* Sarcomas of soft tissues or viscera ;
* Inoperable metastatic or locally advanced disease ;
* Indication for 2nd-line treatment with pazopanib, trabectedine, eribulin, ifosfamide or dacarbazine after failure of 1st-line anthracycline therapy ;
* Patient covered by French social security ;
* Written, signed, informed consent ;

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Severe toxicity in the first 3 months of treatment
timeFrame: 3 months
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 24 months
measure: Overall survival (OS)
timeFrame: 24 months
measure: Severe toxicity
timeFrame: 24 months
measure: Nature of severe AEs
timeFrame: 24 months
measure: AEs leading to hospitalization
timeFrame: 24 months
measure: Survival weighted by quality of life
timeFrame: 24 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Léon Bérard
state: Auvergne-Rhône-Alpes
city: Besançon
country: France
facility: CHU Jean Minjoz
state: Bourgogne-Franche-Comté
city: Rennes
country: France
facility: Centre Eugène Marquis
state: Bretagne
city: Strasbourg
country: France
facility: Institut de Cancérologie Strasbourg
state: Grand Est
city: Lille
country: France
facility: Centre Oscar Lambret
state: Hauts-de-France
city: Poitiers
country: France
facility: CHU de Poitiers
state: Nouvelle-Aquitaine
city: Toulouse
country: France
facility: Institut Claudius Regaud
state: Occitanie
city: Saint-Herblain
country: France
facility: Institut de Cancérologie de l'Ouest
state: Pays de la Loire
city: Paris
country: France
facility: Hôpital Pitié-Salpêtrière AP-HP
state: Île-de-France
city: Villejuif
country: France
facility: Gustave Roussy
state: Île-de-France
Study officials:
affiliation: Centre Oscar Lambret
name: Diane PANNIER, MD
role: PRINCIPAL_INVESTIGATOR
References: