Superiority Trial Evaluating Digitalized Information Media for Patients with Advanced Sarcomas Receiving Second Line Treatment.
- Conditions
- Locally Advanced Soft Tissue SarcomaSarcoma Metastatic
- Interventions
- Other: Dematerialized Personalized Care Plan (ePCP)
- Registration Number
- NCT06211257
- Lead Sponsor
- Centre Oscar Lambret
- 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 second-line 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.
- 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 second-line treatment with pazopanib, tracbectedine, eribuline, ifosfamide or dacarbazine after failure of a first-line anthracycline-based regimen.
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 377
- Sarcomas of soft tissues or viscera ;
- Inoperable metastatic or locally advanced disease ;
- Indication for 2nd-line treatment with pazopanib, trabectedine, eribulin, ifosfamide or dacarbazine after failure of 1st-line anthracycline therapy ;
- Patient covered by French social security ;
- Written, signed, informed consent ;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group : demateralized PCP Dematerialized Personalized Care Plan (ePCP) Patient will receive standard support PCP and dematerialized PCP (ePCP)
- Primary Outcome Measures
Name Time Method Severe toxicity in the first 3 months of treatment 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 Outcome Measures
Name Time Method Severe toxicity 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.Survival weighted by quality of life 24 months Survival weighted by quality of life with the "Quality adjusted Time Without Symptoms and Toxicit" method (Q-Twist)
AEs leading to hospitalization 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.
Overall survival (OS) 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.
Progression-free survival (PFS) 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.
Nature of severe AEs 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;
Trial Locations
- Locations (10)
Centre Léon Bérard
🇫🇷Lyon, Auvergne-Rhône-Alpes, France
CHU Jean Minjoz
🇫🇷Besançon, Bourgogne-Franche-Comté, France
Centre Eugène Marquis
🇫🇷Rennes, Bretagne, France
Institut de Cancérologie Strasbourg
🇫🇷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, France
Hôpital Pitié-Salpêtrière AP-HP
🇫🇷Paris, Île-de-France, France
Gustave Roussy
🇫🇷Villejuif, Île-de-France, France