Propranolol With Standard Chemoradiation for Esophageal Adenocarcinoma

Last updated: April 7, 2025
Sponsor: Roswell Park Cancer Institute
Overall Status: Active - Recruiting

Phase

2

Condition

Digestive System Neoplasms

Esophageal Disorders

Esophageal Cancer

Treatment

Propranolol

Carboplatin

Intensity Modulated Radiation Therapy

Clinical Study ID

NCT04682158
I 630420
  • Ages > 18
  • All Genders

Study 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

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

Total Participants: 106
Treatment Group(s): 5
Primary Treatment: Propranolol
Phase: 2
Study Start date:
April 01, 2021
Estimated Completion Date:
April 01, 2027

Study 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.

Connect with a study center

  • Roswell Park Cancer Institute

    Buffalo, New York 14263
    United States

    Active - Recruiting

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