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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
Select...
I am fully active and can carry on all my pre-disease activities without restriction.
Select...
I am receiving specific treatment for esophageal cancer before surgery.

Timeline

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

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor
405 Previous Clinical Trials
31,226 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
~49 spots leftby Apr 2027
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