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RecruitingNCT04682158Updated Jan 2, 2026

Propranolol With Standard Chemoradiation for Esophageal Adenocarcinoma

A Phase 2 interventional study of Carboplatin and 3 Dimensional Conformal Radiation Therapy in Esophageal Adenocarcinoma, sponsored by Roswell Park Cancer Institute. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-02.

Sponsored by Roswell Park Cancer Institute · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2021; still recruiting 5 years 6 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
106
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

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

Read the detailed description

PRIMARY OBJECTIVE:

I. To determine the safety and efficacy of propranolol hydrochloride (propranolol) in combination with standard neoadjuvant/definitive chemotherapy or chemotherapy-immunotherapy or chemoradiation therapy (CRT) for esophageal cancer.

SECONDARY OBJECTIVE:

I. To estimate overall survival (OS) and pathologic response rate in patients that undergo surgery.

02

Conditions studied

  • Esophageal Adenocarcinoma
03

In context

Adenocarcinoma Of Esophagus

116 studies on the registry are indexed under Adenocarcinoma Of Esophagus; 72 are open to participants now.

This study's planned enrollment of 106 is above the median of 78 across 101 interventional studies indexed under Adenocarcinoma Of Esophagus.

Browse Adenocarcinoma Of Esophagus studies →

Lead sponsor

Roswell Park Cancer Institute is the lead sponsor of 412 studies on the registry; 62 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 21 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
106 participants (estimated)

Study 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.

    Drug: Carboplatin · Radiation: 3 Dimensional Conformal Radiation Therapy · Radiation: Intensity Modulated Radiation Therapy · Drug: Paclitaxel

  • Active comparator
    Chemoradiation Therapy - Group II

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

    Radiation: 3 Dimensional Conformal Radiation Therapy

  • 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.

    Radiation: 3 Dimensional Conformal Radiation Therapy · Drug: Propranolol · Radiation: Intensity Modulated Radiation Therapy

Interventions

  • DrugCarboplatin

    Given IV

    Also known as: (SP-4-2)-diammine[1,1-cyclobutanedicarboxylato(2--)-O,O'']platinum, Blastocarb, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplatin, Ribocarbo

  • Radiation3 Dimensional Conformal Radiation Therapy

    Undergo 3D CRT

    Also known as: 3D-CRT, Radiation

  • DrugPropranolol

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

    Also known as: 2-Propanol-1-[(1-methylethyl)amino]-3-(1-naphthalenyloxy) Hydrochloride, 318-98-9, Inderal, Innopran XL

  • RadiationIntensity Modulated Radiation Therapy

    Undergo IMRT

    Also known as: IMRT

  • DrugPaclitaxel

    Given IV

    Also known as: 33069-62-4, 5Beta,20-epoxy-1,2alpha, Anzatax, Bristaxol, Praxel, Taxol

06

What researchers measure

Primary outcomes

  1. Occurrence of Adverse Events

    To determine the safety and efficacy of the combination of propranolol plus chemoradiation

    Time frame: Up to 5 years

  2. Progression Free Survival

    Imaging findings from first radiation treatment to progression of disease

    Time frame: UP to 5 years

Secondary outcomes

  1. Overall Survival

    will be assessed by chart review of date of last follow-up or date of death

    Time frame: Up to 5 years

07

Study locations

1 of 1 sites recruiting
  • Roswell Park Cancer Institute
    Buffalo, New York 14263, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04682158
Lead sponsor
Roswell Park Cancer Institute
Responsible party
Sponsor
First posted
Dec 23, 2020
Start date
Apr 1, 2021
Primary completion
Apr 1, 2029 (estimated)
Completion
Apr 1, 2029 (estimated)
Last update
Jan 2, 2026

Study contacts

ASK RPCI
Contact
askroswell@roswellpark.org
1-800-767-9355
Anurag Singh, MD
principal investigator · Roswell Park Cancer Institute

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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