Ignite Creation Date:
2024-07-17 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06476704
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-21
Brief Title:
Study of Preoperative RAdiation Therapy With Concomitant Liposomal Transcrocetin L-TC in Soft tISsue Sarcomas
Sponsor:
Institut de cancérologie Strasbourg Europe
Organization:
Institut de cancérologie Strasbourg Europe
Study Overview
Official Title:
Phase 2 Study of Preoperative RAdiation Therapy With Concomitant Liposomal Transcrocetin L-TC in Soft tISsue Sarcomas
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
PRACTISS
Brief Summary:
This is phase II randomized multicenter study of treatment with liposomal trasncrocetin L-TC and preoperative hypofractionated radiotherapy in patients who were aged 18 years or older with documented localised or locally advanced soft-tissue sarcoma of the extremity
Detailed Description:
Eligible patients will be randomly assigned 21 to receive a preoperative hypofractionated radiotherapy alone Arm A or L-TC with preoperative hypofractionated radiotherapy HFRT Arm B
All eligible patients will be administered L-TC at a dose of 300 mg as an IV perfusion daily and the radiation session will be between 30 min and 1h30 after the end of the perfusion
The experimental treatment L-TC is a liposomal formulation of trans crocetin developed by LEAF4Life Inc
Control group will receive HFRT alone
All eligible patients will be administered L-TC at a dose of 300 mg as an IV perfusion daily and the radiation session will be between 30 min and 1h30 after the end of the perfusion
The experimental treatment L-TC is a liposomal formulation of trans crocetin developed by LEAF4Life Inc
Control group will receive HFRT alone
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2024-515668-30-00 | CTIS | None | None |