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

Locally Advanced Soft Tissue Sarcoma Clinical Trial

— ePPS-2202  

Official title:

Phase 3 Superiority Trial Evaluating the Benefit of Dematerialized Information Media for Patients With Advanced Sarcomas Receiving Second Line Treatment.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06211257
• Other study ID #: ePPS-2202
• Secondary ID: 2023-A00984-41
• Status: Recruiting
• Phase: N/A
• Start date: May 29, 2024
• Est. completion date: March 2028

Study information

• Verified date: May 2024
• Source: Centre Oscar Lambret
• Contact: PANNIER Diane, DR
• Phone: 03.20.29.59.59
• Email: d-pannier[@]o-lambret.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 377
• Est. completion date: March 2028
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 ;

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Locally Advanced Soft Tissue Sarcoma
• Sarcoma
• Sarcoma Metastatic

Intervention

Other:
• Dematerialized Personalized Care Plan (ePCP)
Post-treatment support with standard support combined with dematerialized support

Locations

Country	Name	City	State
France	CHU Jean Minjoz	Besançon	Bourgogne-Franche-Comté
France	Centre Oscar Lambret	Lille	Hauts-de-France
France	Centre Léon Bérard	Lyon	Auvergne-Rhône-Alpes
France	Hôpital Pitié-Salpêtrière AP-HP	Paris	Île-de-France
France	CHU de Poitiers	Poitiers	Nouvelle-Aquitaine
France	Centre Eugène Marquis	Rennes	Bretagne
France	Institut de Cancérologie de l'Ouest	Saint-Herblain	Pays De La Loire
France	Institut de Cancérologie Strasbourg	Strasbourg	Grand Est
France	Institut Claudius Regaud	Toulouse	Occitanie
France	Gustave Roussy	Villejuif	Île-de-France

Sponsors (2)

Lead Sponsor	Collaborator
Centre Oscar Lambret	Canceropôle Nord Ouest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.	24 months
Secondary	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
Secondary	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;	24 months
Secondary	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
Secondary	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