Ignite Creation Date:
2025-12-18 @ 8:54 AM
Ignite Modification Date:
2025-12-23 @ 6:13 PM
Study NCT ID:
NCT06670976
Status:
None
Last Update Posted:
2025-08-26 00:00:00
First Post:
2024-10-31 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Propranolol Plus Standard Radiation Therapy Before Surgery for the Treatment of Patients With Soft Tissue Sarcoma
Sponsor:
None
Organization:
Study Overview
Official Title:
Pilot Study of Soft Tissue Sarcoma Treated With Propranolol and Radiation
Status:
None
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
to be submitted at a later date
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
PRIMARY OBJECTIVE:
I. To establish the safety and tolerability of adding propranolol to standard RT for soft tissue sarcoma.
SECONDARY OBJECTIVE:
I. To evaluate the response of tumor immune microenvironment to treatments for patients.
OUTLINE:
Patients receive propranolol orally (PO) twice daily (BID) for 2 weeks prior to standard of care RT (weeks 1 and 2) and then during and after standard of care RT (weeks 3-7). Treatment continues in the absence of disease progression or unacceptable toxicity until the time of standard of care surgery (week 8). Additionally, patients undergo positron emission tomography (PET) scan and/or computed tomography (CT) scan during screening and may undergo blood and tissue biopsy sample collection throughout the trial.
After completion of study treatment, patients are followed up at 5 weeks.
I. To establish the safety and tolerability of adding propranolol to standard RT for soft tissue sarcoma.
SECONDARY OBJECTIVE:
I. To evaluate the response of tumor immune microenvironment to treatments for patients.
OUTLINE:
Patients receive propranolol orally (PO) twice daily (BID) for 2 weeks prior to standard of care RT (weeks 1 and 2) and then during and after standard of care RT (weeks 3-7). Treatment continues in the absence of disease progression or unacceptable toxicity until the time of standard of care surgery (week 8). Additionally, patients undergo positron emission tomography (PET) scan and/or computed tomography (CT) scan during screening and may undergo blood and tissue biopsy sample collection throughout the trial.
After completion of study treatment, patients are followed up at 5 weeks.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: