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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Occurrence of Adverse Events

Progression Free Survival

Secondary outcome measures

Overall Survival

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

Completed Phase 2

~490

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor

402 Previous Clinical Trials

30,701 Total Patients Enrolled

Anurag Singh, MDPrincipal InvestigatorRoswell Park Cancer Institute

1 Previous Clinical Trials

30 Total Patients Enrolled

Media Library

Propranolol Clinical Trial Eligibility Overview. Trial Name: NCT04682158 — Phase 2

Esophageal Cancer Research Study Groups: Chemoradiation Therapy plus Propanolol, Chemoradiation Therapy - Group I, Chemoradiation Therapy - Group II

Esophageal Cancer Clinical Trial 2023: Propranolol Highlights & Side Effects. Trial Name: NCT04682158 — Phase 2

Propranolol 2023 Treatment Timeline for Medical Study. Trial Name: NCT04682158 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research actively searching for participants?

"According to the details found on clinicaltrials.gov, this medical experiment is presently recruiting participants. It was first made available April 1st 2021 and has seen its last update August 3rd 2022."

Answered by AI

In what treatments is Propranolol typically employed?

"Propranolol is a popular treatment for initial diagnosis, but it can also help alleviate symptoms of metastatic bladder cancer, angina pectoris, and advanced testicular cancer."

Answered by AI

Could you please outline other investigations that have looked into Propranolol?

"Currently, 1214 studies are in progress investigating Propranolol. Among these trials, 337 have reached the third phase of clinical development. The majority of investigations into this drug occur in Shanghai but there are over 65 thousand other locations running research for it as well."

Answered by AI

What is the total participant count in this research endeavor?

"Correct. The clinical trial information hosted on clinicaltrials.gov verifies that the medical study—which was initially posted April 1st 2021—is currently enrolling participants. Sixty patients need to be recruited from one site."

Answered by AI

To what extent can Propranolol have adverse effects on a person's wellbeing?

"Our internal team at Power deemed the safety of Propranolol a 2, due to Phase 2 trial data that indicates some evidence for safety but no clinical information supporting efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Propranolol With Standard Chemoradiation for Esophageal Adenocarcinoma

2021. "Propranolol With Standard Chemoradiation for Esophageal Adenocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04682158.

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