Superiority Trial Evaluating Digitalized Information Media for Patients With Advanced Sarcomas Receiving Systemic Treatment. (ePPS-2202)

Centre Oscar Lambret

Status

Enrolling

Conditions

Locally Advanced Soft Tissue Sarcoma

Sarcoma Metastatic

Treatments

Other: Dematerialized Personalized Care Plan (ePCP)

Study type

Interventional

Funder types

Other

Identifiers

NCT06211257

ePPS-2202

2023-A00984-41 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

377 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.