Superiority Trial Evaluating Digitalized Information Media for Patients with Advanced Sarcomas Receiving Second Line Treatment.

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06211257
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Centre Oscar Lambret
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Diane PANNIER, MD
Principal Investigator Affiliation Centre Oscar Lambret
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Sarcoma Metastatic, Locally Advanced Soft Tissue Sarcoma
Additional Details

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.

Arms & Interventions

Arms

No Intervention: Control group : standard PCP

Patient will receive standard support PCP

Experimental: Experimental group : demateralized PCP

Patient will receive standard support PCP and dematerialized PCP (ePCP)

Interventions

Other: - Dematerialized Personalized Care Plan (ePCP)

Post-treatment support with standard support combined with dematerialized support

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Centre Léon Bérard, Lyon 2996944, Auvergne-Rhône-Alpes 11071625, France

Status

Recruiting

Address

Centre Léon Bérard

Lyon 2996944, Auvergne-Rhône-Alpes 11071625, 69373

Site Contact

Armelle DUFRESNE, MD

[email protected]

+33 (0) 4 69 85 61 47

CHU Jean Minjoz, Besançon 3033123, Bourgogne-Franche-Comté 11071619, France

Status

Recruiting

Address

CHU Jean Minjoz

Besançon 3033123, Bourgogne-Franche-Comté 11071619, 25000

Site Contact

Loic CHAIGNEAU, MD

[email protected]

+33 (0) 3 70 63 20 05

Centre Eugène Marquis, Rennes 2983990, Brittany Region 3030293, France

Status

Not yet recruiting

Address

Centre Eugène Marquis

Rennes 2983990, Brittany Region 3030293, 35042

Site Contact

Perrine VUAGNAT, MD

[email protected]

+33 (0) 2 99 25 29 69

Institut de Cancérologie Strasbourg, Strasbourg 2973783, Grand Est 11071622, France

Status

Recruiting

Address

Institut de Cancérologie Strasbourg

Strasbourg 2973783, Grand Est 11071622, 67033

Site Contact

Sophie MARTIN, MD

[email protected]

+33 (0) 3 68 76 72 07

Centre Oscar Lambret, Lille 2998324, Hauts-de-France 11071624, France

Status

Recruiting

Address

Centre Oscar Lambret

Lille 2998324, Hauts-de-France 11071624, 59020

Site Contact

Diane PANNIER, MD

[email protected]

+33 (0) 3 20 29 59 59

CHU de Poitiers, Poitiers 2986495, Nouvelle-Aquitaine 11071620, France

Status

Recruiting

Address

CHU de Poitiers

Poitiers 2986495, Nouvelle-Aquitaine 11071620, 86021

Site Contact

Marjorie HIRSCH, MD

[email protected]

+33 (0) 5 49 44 07 11

Institut Claudius Regaud, Toulouse 2972315, Occitanie 11071623, France

Status

Withdrawn

Address

Institut Claudius Regaud

Toulouse 2972315, Occitanie 11071623, 31059

Institut de Cancérologie de l'Ouest, Saint-Herblain 2979590, Pays de la Loire Region 2988289, France

Status

Recruiting

Address

Institut de Cancérologie de l'Ouest

Saint-Herblain 2979590, Pays de la Loire Region 2988289, 44805

Site Contact

Emmanuelle BOMPAS, MD

[email protected]

+33 (0) 2 40 67 99 00

Hôpital Pitié-Salpêtrière AP-HP, Paris 2988507, Île-de-France Region 3012874, France

Status

Not yet recruiting

Address

Hôpital Pitié-Salpêtrière AP-HP

Paris 2988507, Île-de-France Region 3012874, 75013

Site Contact

Aurore VOZY, MD

[email protected]

+33 (0) 1 42 16 05 08

Gustave Roussy, Villejuif 2968705, Île-de-France Region 3012874, France

Status

Recruiting

Address

Gustave Roussy

Villejuif 2968705, Île-de-France Region 3012874, 94800

Site Contact

Benjamin VERRET, MD

[email protected]

+33 (0) 1 42 11 42 11

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