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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A00984-41 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| Canceropôle Nord Ouest | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dematerialized Personalized Care Plan (ePCP) | Other | Post-treatment support with standard support combined with dematerialized support |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 months |
| Overall survival (OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| PANNIER Diane, DR | Contact | 03.20.29.59.59 | d-pannier@o-lambret.fr | |
| THERY Julien, MD | Contact | J-THERY@o-lambret.fr |
| Name | Affiliation | Role |
|---|---|---|
| Diane PANNIER, MD | Centre Oscar Lambret | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Léon Bérard | Recruiting | Lyon | Auvergne-Rhône-Alpes | 69373 | France |
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Randomized 1:1
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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. |
| 24 months |
| 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. | 24 months |
| 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:
| 24 months |
| 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. | 24 months |
| Survival weighted by quality of life | Survival weighted by quality of life with the "Quality adjusted Time Without Symptoms and Toxicit" method (Q-Twist) | 24 months |
| 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. | 3 months |
| CHU Jean Minjoz | Recruiting | Besançon | Bourgogne-Franche-Comté | 25000 | France |
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| Centre Eugène Marquis | Not yet recruiting | Rennes | Brittany Region | 35042 | France |
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| Centre Paul Strauss | Recruiting | Strasbourg | Grand Est | 67033 | France |
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| Centre Oscar Lambret | Recruiting | Lille | Hauts-de-France | 59020 | France |
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| CHU de Poitiers | Recruiting | Poitiers | New Aquitaine | 86021 | France |
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| Institut Claudius Regaud | Withdrawn | Toulouse | Occitanie | 31059 | France |
| Institut de Cancérologie de l'Ouest | Recruiting | Saint-Herblain | Pays de la Loire Region | 44805 | France |
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| Institut de Cancérologie de Lorraine | Not yet recruiting | Vandœuvre-lès-Nancy | 54519 | France |
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| Hôpital Pitié-Salpêtrière AP-HP | Not yet recruiting | Paris | Île-de-France Region | 75013 | France |
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| Gustave Roussy | Recruiting | Villejuif | Île-de-France Region | 94800 | France |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| D019150 | Neuroaxonal Dystrophies |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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