Recruiting
Phase 2

Propranolol with Chemoradiation

Sponsor:

Roswell Park Cancer Institute

Code:

NCT04682158

Conditions

Esophageal Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Carboplatin

3 Dimensional Conformal Radiation Therapy

Propranolol

Intensity Modulated Radiation Therapy

Paclitaxel

Study Details

Brief 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, or definitive chemotherapy or chemotherapy-immunotherapy and will be considered separately as a single arm prospective cohort

Conditions

Esophageal Adenocarcinoma

Study ID

NCT04682158

Start date

Apr 1, 2021

Status verified date

Dec, 2025

Completion date

Apr 1, 2029

Anticipated

Primary completion date

Apr 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Undergoing definitive or neoadjuvant CRT for histologically confirmed esophageal adenocarcinoma
  • Have an ECOG performance status of 0-1
  • Have the ability to swallow and retain oral medication. If a patient is not able to swallow, they are still eligible for study provided they have an enteric feeding placed which will permit administration of crushed tablets or liquid formula propranolol prior to first radiation treatment
  • Participants of child-bearing potential must have a negative pregnancy test at study entry And then agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. - Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
  • Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure.

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), 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)
  • Pregnant or nursing female participants,
  • Unwilling or unable to follow protocol requirements
  • Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug

Study Design

Enrollment

106 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Chemoradiation Therapy - Group I

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.

active comparator: Chemoradiation Therapy - Group II

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

experimental: Chemoradiation Therapy plus Propanolol

Patients undergo radiation therapy as in Group I. Patients receive propranolol PO BID for 4-8 weeks while receiving standard neoadjuvant/definitive chemotherapy or chemotherapy-immunotherapy or CRT in the absence of disease progression or unacceptable toxicity.

Interventions

Carboplatin

Given IV

3 Dimensional Conformal Radiation Therapy

Undergo 3D CRT

Propranolol

Subject will be treated with 30 mg po BID Propranolol for up to 6 weeks

Intensity Modulated Radiation Therapy

Undergo IMRT

Paclitaxel

Given IV

Primary outcome measure

  • Occurrence of Adverse Events [ Time Frame: Up to 5 years ]
  • Progression Free Survival [ Time Frame: UP to 5 years ]

Central Contacts and Locations

Central contacts

ASK RPCI

1-800-767-9355askroswell@roswellpark.org

Locations

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

More Information

Sponsor

Roswell Park Cancer Institute

Last update posted

Jan 2, 2026

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Roswell Park Cancer Institute on 2026-01-02.