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, or definitive chemotherapy or chemotherapy-immunotherapy and will be considered separately as a single arm prospective cohort
PRIMARY OBJECTIVE: I. To determine the safety and efficacy of propranolol hydrochloride (propranolol) in combination with standard neoadjuvant/definitive chemotherapy or chemotherapy-immunotherapy or chemoradiation therapy (CRT) for esophageal cancer. SECONDARY OBJECTIVE: I. To estimate overall survival (OS) and pathologic response rate in patients that undergo surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
106
Given IV
Undergo 3D CRT
Subject will be treated with 30 mg po BID Propranolol for up to 6 weeks
Roswell Park Cancer Institute
Buffalo, New York, United States
RECRUITINGOccurrence of Adverse Events
To determine the safety and efficacy of the combination of propranolol plus chemoradiation
Time frame: Up to 5 years
Progression Free Survival
Imaging findings from first radiation treatment to progression of disease
Time frame: UP to 5 years
Overall Survival
will be assessed by chart review of date of last follow-up or date of death
Time frame: Up to 5 years
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Undergo IMRT
Given IV