Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT04682158
Status:
RECRUITING
Last Update Posted:
2025-04-08
First Post:
2020-12-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Propranolol With Standard Chemoradiation for Esophageal Adenocarcinoma
Sponsor:
Roswell Park Cancer Institute
Organization:
Study Overview
Official Title:
Propranolol With Standard Chemoradiation for Esophageal Adenocarcinoma A Phase II Study
Status:
RECRUITING
Status Verified Date:
2025-04
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:
None
Brief Summary:
This phase II trial studies the side effects and best dose of propranolol when administered concurrently with SOC neoadjuvant CRT in patients with esophageal carcinoma, with a safety lead-in and dose expansion cohort. Patients who are already on β-blockers will receive standard of care CRT and will be considered separately as a single arm prospective cohort
Detailed Description:
PRIMARY OBJECTIVE:
I. To determine the safety and efficacy of propranolol hydrochloride (propranolol) in combination with standard neoadjuvant/definitive chemoradiation therapy (CRT) for esophageal cancer.
SECONDARY OBJECTIVE:
I. To estimate overall survival (OS) and pathologic response rate in patients that undergo surgery.
I. To determine the safety and efficacy of propranolol hydrochloride (propranolol) in combination with standard neoadjuvant/definitive chemoradiation therapy (CRT) for esophageal cancer.
SECONDARY OBJECTIVE:
I. To estimate overall survival (OS) and pathologic response rate in patients that undergo surgery.
Study Oversight
Has Oversight DMC:
True
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?: