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Sarcoma MetastaticePPSNCT06211257

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

A study testing Dematerialized Personalized Care Plan (ePCP) in people with Sarcoma Metastatic and Locally Advanced Soft Tissue Sarcoma, run by Centre Oscar Lambret at 11 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Dematerialized Personalized Care Plan (ePCP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
377 participants
Where
11 sitesFrance
Study dates
29 May 2024to Apr 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 ;

Who cannot join

  • 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.

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

PANNIER Diane, DR contact

03.20.29.59.59

d-pannier@o-lambret.fr

THERY Julien, MD contact

J-THERY@o-lambret.fr

11 sites in 1 country

France11 sites, 10 recruiting

  • CHU Jean Minjoz

    Besançon, Bourgogne-Franche-Comté, 25000

    Clément BOLOGNINI, MD, +33 (0) 3 70 63 20 05, cbolognini@chu-besancon.fr

    Clement BOLOGNINI, MD

    Recruiting

  • Centre Oscar Lambret

    Lille, Hauts-de-France, 59020

    Diane PANNIER, MD, +33 (0) 3 20 29 59 59, d-pannier@o-lambret.fr

    Diane PANNIER, MD

    Recruiting

  • Centre Léon Bérard

    Lyon, Auvergne-Rhône-Alpes, 69373

    Armelle DUFRESNE, MD, +33 (0) 4 69 85 61 47, armelle.dufresne@lyon-unicancer.fr

    Armelle DUFRESNE, MD

    Recruiting

  • Hôpital Pitié-Salpêtrière AP-HP

    Paris, Île-de-France Region, 75013

    Aurore VOZY, MD, +33 (0) 1 42 16 05 08, aurore.vozy@aphp.fr

    Aurore VOZY, MD

    Not yet recruiting

  • CHU de Poitiers

    Poitiers, New Aquitaine, 86021

    Marjorie HIRSCH, MD, +33 (0) 5 49 44 07 11, marjorie.hirsch@chu-poitiers.fr

    Marjorie HIRSCH, MD

    Recruiting

  • Centre Eugène Marquis

    Rennes, Brittany Region, 35042

    Perrine VUAGNAT, MD, +33 (0) 2 99 25 29 69, p.vuagnat@rennes.unicancer.fr

    Perrine VUAGNAT, MD

    Not yet recruiting

  • Institut de Cancérologie de l'Ouest

    Saint-Herblain, Pays de la Loire Region, 44805

    Emmanuelle BOMPAS, MD, +33 (0) 2 40 67 99 00, emmanuelle.bompas@ico.unicancer.fr

    Emmanuelle BOMPAS, MD

    Recruiting

  • Centre Paul Strauss

    Strasbourg, Grand Est, 67033

    Laura SOMME, MD, +33 (0) 3 68 76 72 07, l.bender@icans.eu

    Laura SOMME, MD

    Recruiting

  • Institut Claudius Regaud

    Toulouse, Occitanie, 31059

    Withdrawn

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, 54519

    Sophie MARTIN, MD, (0)3 83 59 83 31 ext. +33, so.martin@nancy.unicancer.fr

    Sophie MARTIN, MD

    Not yet recruiting

  • Gustave Roussy

    Villejuif, Île-de-France Region, 94800

    Benjamin VERRET, MD, +33 (0) 1 42 11 42 11, benjamin.verret@gustaveroussy.fr

    Benjamin VERRET, MD

    Recruiting

Other trials in France

About this study

Official title: 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.

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.

Read the 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 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.

Being tested
Dematerialized Personalized Care Plan (ePCP)
Keywords
Sarcoma, Advanced, Dematerialised, Care, Plan
Medical subject headings
Sarcoma, Neuroaxonal Dystrophies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dematerialized Personalized Care Plan (ePCP)Other

    Post-treatment support with standard support combined with dematerialized support

Study groups in NCT06211257
Study groupRoleWhat they receive
Control group : standard PCPNo interventionPatient will receive standard support PCP
Experimental group : demateralized PCPExperimentalPatient will receive standard support PCP and dematerialized PCP (ePCP)
Receives: Other: Dematerialized Personalized Care Plan (ePCP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 months

Secondary outcomes (7)

  1. Progression-free survival (PFS)

    PFS will be defined as the time from randomisation to investigator-assessed disease progression (RECIST 1.1 or clinical). No progressive-patients will be censured at the 24-months follow-up.

    Measured: 24 months

  2. Overall survival (OS)

    OS will be defined as the time from randomisation to patient's death regardless of the cause. Alive patients will be censured at the 24-month follow-up.

    Measured: 24 months

  3. Severe toxicity

    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 relationship, occurring between randomization and the end of treatment + 30days or the stard of a new systemic anticancer 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.

    Measured: 24 months

  4. Nature of severe AEs

    Description of the nature of severe adverse events occuring between randomization and the end of treatment + 30days or the start of a new systemic anticancer treatment or the 24-month follow-up, especially:

    • Asthenia ;
    • Gastrointestinal disorders: vomiting, anorexia, mucositis/aphthosis, diarrhea, constipation;
    • Skin disorders: hand-foot syndrome, phototoxicity, dry skin skin dryness;
    • Hypertension;
    • Hematological toxicity ;
    • Hematuric cystitis with ifosfamide;
    • Ifosfamide encephalopathy;
    • Extravasation with trabectedine;

    Measured: 24 months

  5. AEs leading to hospitalization

    Description of the adverse events leading to hospitalisation occuring between randomization and the end of treatment + 30days or the start of a new systemic anticancer treatment or the 24-month follow-up.

    Measured: 24 months

  6. Survival weighted by quality of life

    Survival weighted by quality of life with the "Quality adjusted Time Without Symptoms and Toxicit" method (Q-Twist)

    Measured: 24 months

  7. Quality of life assessed by EORTC QLQ-C30 questionnaire

    Quality of life assessed by "Quality of Life of Cancer Patients Questionnaire" (called EORTC QLQ-C30) at Baseline and at first oncological follow-up. The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale.

    All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2024
  2. Study start29 May 2024
  3. Primary completionJul 2028 (estimated)
  4. Study completionApr 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized 1:1
Masking
None (open label)
Enrolment
377 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06211257
Sponsor's protocol ID
ePPS-2202
Other IDs
2023-A00984-41
Acronym
ePPS
Status last verified
Feb 2026
First submitted
8 Jan 2024
Last updated
18 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Dematerialized Personalized Care Plan (ePCP) in people with Sarcoma Metastatic and Locally Advanced Soft Tissue Sarcoma, run by Centre Oscar Lambret at 11 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact PANNIER Diane, DR (03.20.29.59.59, d-pannier@o-lambret.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Severe toxicity in the first 3 months of treatment (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06211257.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.

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