RecruitingNot ApplicableNCT06211257

Superiority Trial Evaluating Digitalized Information Media for Patients With Advanced Sarcomas Receiving Systemic Treatment.

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.


Sponsor

Centre Oscar Lambret

Enrollment

377 participants

Start Date

May 29, 2024

Study Type

INTERVENTIONAL

Conditions

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 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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria6

  • 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.

Interventions

OTHERDematerialized Personalized Care Plan (ePCP)

Post-treatment support with standard support combined with dematerialized support


Locations(11)

Centre Léon Bérard

Lyon, Auvergne-Rhône-Alpes, France

CHU Jean Minjoz

Besançon, Bourgogne-Franche-Comté, France

Centre Eugène Marquis

Rennes, Brittany Region, France

Centre Paul Strauss

Strasbourg, Grand Est, France

Centre Oscar Lambret

Lille, Hauts-de-France, France

CHU de Poitiers

Poitiers, Nouvelle-Aquitaine, France

Institut Claudius Regaud

Toulouse, Occitanie, France

Institut de Cancérologie de l'Ouest

Saint-Herblain, Pays de la Loire Region, France

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, France

Hôpital Pitié-Salpêtrière AP-HP

Paris, Île-de-France Region, France

Gustave Roussy

Villejuif, Île-de-France Region, France

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NCT06211257


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