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NCT Number: NCT06211257

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

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.

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Key information

Conditions

Sarcoma Metastatic Brain Diseases Central Nervous System Diseases Locally Advanced Soft Tissue Sarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Nervous System Diseases Neuroaxonal Dystrophies Sarcoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dematerialized Personalized Care Plan (ePCP)

Other

Post-treatment support with standard support combined with dematerialized support

Primary outcomes

  1. Severe toxicity in the first 3 months of treatment

    Time frame: 3 months

    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.

Secondary outcomes

  1. Progression-free survival (PFS)

    Time frame: 24 months

    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.

  2. Overall survival (OS)

    Time frame: 24 months

    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.

  3. Severe toxicity

    Time frame: 24 months

    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.

  4. Nature of severe AEs

    Time frame: 24 months

    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;

  5. AEs leading to hospitalization

    Time frame: 24 months

    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.

  6. Survival weighted by quality of life

    Time frame: 24 months

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

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

    Time frame: 3 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

PANNIER Diane, DR

CONTACT

[email protected]

03.20.29.59.59

THERY Julien, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Collaborators

  • Canceropôle Nord Ouest

Registry information

Official study 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.

Acronym: ePPS

Important dates

Study start
2024
Primary completion
2028
Study completion
2030
First posted
Jan 18, 2024
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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