Propranolol With Standard Chemoradiation for Esophageal Adenocarcinoma
Propranolol With Standard Chemoradiation for Esophageal Adenocarcinoma
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
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.
Inclusion Criteria:

 -  Undergoing definitive or neoadjuvant CRT for histologically confirmed esophageal
 adenocarcinoma

 -  Have an ECOG performance status of 0-1

 -  Have the ability to swallow and retain oral medication (Note: Placement of an enteric
 feeding tube after the patient has signed informed consent will not make them
 ineligible to participate in the study - liquid formula propranolol will be made
 available).

 -  Participants of child-bearing potential must have a negative pregnancy test at study
 entry And then agree to use adequate contraceptive methods (e.g., hormonal or barrier
 method of birth control; abstinence) prior to study entry. - Should a woman become
 pregnant or suspect she is pregnant while she or her partner is participating in this
 study, she should inform her treating physician immediately.

 -  Participant or legal representative must understand the investigational nature of this
 study and sign an Independent Ethics Committee/Institutional Review Board approved
 written informed consent form prior to receiving any study related procedure.

 Exclusion Criteria:

 -  Contraindications to the use of beta-blockers, e.g.; uncontrolled depression, unstable
 angina pectoris, uncontrolled heart failure (New York Heart Association (NYHA) Grade
 III or IV), hypotension ( systolic blood pressure <100 mmHg), severe asthma or COPD,
 uncontrolled type I or type II diabetes mellitus (HbA1C >8.5 or fasting plasma glucose
 > 160 mg/dL at screening), symptomatic peripheral arterial disease or Raynaud's
 syndrome, untreated pheochromocytoma, current calcium channel blocker use
 (Non-dihydropyridines such as verapamil) or rhythm control agents such as digoxin and
 amiodarone. Patients with pacemakers will be excluded

 -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
 infection,symptomatic congestive heart failure, unstable angina pectoris, psychiatric
 illness/social situations that would limit compliance with study requirements, cardiac
 arrhythmia (atrial fibrillation/flutter), severe bradycardia (heart rate of <50 beats
 per minute or 1st/ 2nd /3rd degree heart block)

 -  Pregnant or nursing female participants,

 -  Unwilling or unable to follow protocol requirements

 -  Any condition which in the Investigator's opinion deems the participant an unsuitable
 candidate to receive study drug