Phase
Condition
Digestive System Neoplasms
Esophageal Disorders
Esophageal Cancer
Treatment
Propranolol
Carboplatin
Intensity Modulated Radiation Therapy
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Undergoing definitive or neoadjuvant CRT for histologically confirmed esophagealadenocarcinoma
Have an ECOG performance status of 0-1
Have the ability to swallow and retain oral medication. If a patient is not able toswallow, they are still eligible for study provided they have an enteric feedingplaced which will permit administration of crushed tablets or liquid formulapropranolol prior to first radiation treatment
Participants of child-bearing potential must have a negative pregnancy test at studyentry And then agree to use adequate contraceptive methods (e.g., hormonal orbarrier method of birth control; abstinence) prior to study entry. - Should a womanbecome pregnant or suspect she is pregnant while she or her partner is participatingin this study, she should inform her treating physician immediately.
Participant must understand the investigational nature of this study and sign anIndependent Ethics Committee/Institutional Review Board approved written informedconsent form prior to receiving any study related procedure.
Exclusion
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), severeasthma or COPD, uncontrolled type I or type II diabetes mellitus (HbA1C >8.5 orfasting plasma glucose > 160 mg/dL at screening), symptomatic peripheral arterialdisease or Raynaud's syndrome, untreated pheochromocytoma, current calcium channelblocker use (Non-dihydropyridines such as verapamil) or rhythm control agents suchas digoxin and amiodarone. Patients with pacemakers will be excluded
Uncontrolled intercurrent illness including, but not limited to, ongoing or activeinfection,symptomatic congestive heart failure, unstable angina pectoris,psychiatric illness/social situations that would limit compliance with studyrequirements, 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 anunsuitable candidate to receive study drug
Study Design
Study Description
Connect with a study center
Roswell Park Cancer Institute
Buffalo, New York 14263
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.