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Propranolol + Chemoradiation for Esophageal Cancer

Phase 2

Recruiting

Led By Anurag Singh, MD

Research Sponsored by Roswell Park Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have an ECOG performance status of 0-1

Undergoing definitive or neoadjuvant CRT for histologically confirmed esophageal adenocarcinoma

Must not have

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer treatment that uses propranolol in conjunction with standard of care CRT (chemoradiotherapy) for patients with esophageal carcinoma.

Who is the study for?

This trial is for adults with esophageal adenocarcinoma who can swallow pills or have a feeding tube, are not pregnant, agree to use birth control, and have an ECOG performance status of 0-1. Excluded are those with severe heart issues, uncontrolled illnesses, certain psychiatric conditions, or on specific heart medications.

What is being tested?

The study tests the safety and optimal dose of propranolol alongside standard chemoradiation therapy (CRT) in treating esophageal carcinoma. It includes patients already on β-blockers receiving standard CRT as a separate group for comparison.

What are the potential side effects?

Potential side effects include those related to beta-blockers like propranolol such as low heart rate, fatigue, digestive issues; and chemotherapy-related effects like nausea, hair loss, increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active and can carry on all my pre-disease activities without restriction.

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I am receiving specific treatment for esophageal cancer before surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have conditions that prevent me from using beta-blockers.

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I do not have any severe illnesses or heart problems that would stop me from following the study's requirements.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Occurrence of Adverse Events

Progression Free Survival

Secondary study objectives

Overall Survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Chemoradiation Therapy plus PropanololExperimental Treatment3 Interventions

Patients undergo radiation therapy as in Group I. Patients receive propranolol PO BID for 4-6 weeks while receiving CRT in the absence of disease progression or unacceptable toxicity.

Group II: Chemoradiation Therapy - Group IActive Control4 Interventions

Patients receiving beta-blockers undergo radiation therapy in the form of IMRT or 3D CRT over 23-28 fractions for 5 days per week (Monday-Friday) for 5 weeks, and receive paclitaxel IV QW and carboplatin IV QW for 5 weeks in the absence of disease progression or unacceptable toxicity.

Group III: Chemoradiation Therapy - Group IIActive Control1 Intervention

Patients undergo CRT as in Group I in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Propranolol

2010

Completed Phase 4

~1290

Intensity Modulated Radiation Therapy

2017