Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06211257
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-01-08
Brief Title:
Superiority Trial Evaluating Digitalized Information Media for Patients With Advanced Sarcomas Receiving Second Line Treatment
Sponsor:
Centre Oscar Lambret
Organization:
Centre Oscar Lambret
Study Overview
Official Title:
Phase 3 Superiority Trial Evaluating the Benefit of Dematerialized Information Media for Patients With Advanced Sarcomas Receiving Second Line Treatment
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ePPS-2202
Brief Summary:
ePPS-2202 is a study designed to evaluate the benefits of a dematerialised personalised care plan PCP compared to standard informationPCP 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
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 randomisedopen-label controlled multicentre interventional study designed to evaluate the benefits of a dematerialised personalised care plan PCP compared to standard informationPCP 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 v50
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 v50
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A00984-41 | OTHER | ANSM | None |