NCT06211257

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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
377

participants targeted

Target at P75+ for not_applicable

Timeline
47mo left

Started May 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

11 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
May 2024Apr 2030

First Submitted

Initial submission to the registry

January 8, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 18, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

May 29, 2024

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2030

Last Updated

March 18, 2026

Status Verified

February 1, 2026

Enrollment Period

4.1 years

First QC Date

January 8, 2024

Last Update Submit

March 16, 2026

Conditions

Sarcoma MetastaticLocally Advanced Soft Tissue Sarcoma

Keywords

SarcomaAdvancedDematerialisedCarePlan

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (7)

  • Progression-free survival (PFS)

    24 months

  • Overall survival (OS)

    24 months

  • Severe toxicity

    24 months

  • Nature of severe AEs

    24 months

  • AEs leading to hospitalization

    24 months

  • +2 more secondary outcomes

Study Arms (2)

Control group : standard PCP

NO INTERVENTION

Patient will receive standard support PCP

Experimental group : demateralized PCP

EXPERIMENTAL

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

Other: Dematerialized Personalized Care Plan (ePCP)

Interventions

Dematerialized Personalized Care Plan (ePCP)OTHER

Post-treatment support with standard support combined with dematerialized support

Experimental group : demateralized PCP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 ;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Centre Léon Bérard

Lyon, Auvergne-Rhône-Alpes, 69373, France

RECRUITING

CHU Jean Minjoz

Besançon, Bourgogne-Franche-Comté, 25000, France

RECRUITING

Centre Eugène Marquis

Rennes, Brittany Region, 35042, France

NOT YET RECRUITING

Centre Paul Strauss

Strasbourg, Grand Est, 67033, France

RECRUITING

Centre Oscar Lambret

Lille, Hauts-de-France, 59020, France

RECRUITING

CHU de Poitiers

Poitiers, Nouvelle-Aquitaine, 86021, France

RECRUITING

Institut Claudius Regaud

Toulouse, Occitanie, 31059, France

WITHDRAWN

Institut de Cancérologie de l'Ouest

Saint-Herblain, Pays de la Loire Region, 44805, France

RECRUITING

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

NOT YET RECRUITING

Hôpital Pitié-Salpêtrière AP-HP

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

NOT YET RECRUITING

Gustave Roussy

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

RECRUITING

MeSH Terms

Conditions

SarcomaNeuroaxonal Dystrophies

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Diane PANNIER, MD

    Centre Oscar Lambret

    PRINCIPAL INVESTIGATOR

Central Study Contacts

PANNIER Diane, DR

CONTACT

03.20.29.59.59d-pannier@o-lambret.fr

THERY Julien, MD

CONTACT

J-THERY@o-lambret.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized 1:1
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2024

First Posted

January 18, 2024

Study Start

May 29, 2024

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

April 1, 2030

Last Updated

March 18, 2026

Record last verified: 2026-02

Locations

FR(11)