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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
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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Active, not recruiting NCT03660930 - Nab-Sirolimus and Pazopanib Hydrochloride in Treating Patients With Advanced Nonadipocytic Soft Tissue Sarcomas Phase 1/Phase 2