Propranolol With Standard Chemoradiation for Esophageal Adenocarcinoma

NCT04682158 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: I 630420
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Occurrence of Adverse Events

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

  Up to 5 years

• Progression Free Survival

  Imaging findings from first radiation treatment to progression of disease

  UP to 5 years

Secondary Outcomes (1)

• Overall Survival

  Up to 5 years

Study Arms (3)

Chemoradiation Therapy - Group I

ACTIVE COMPARATOR

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

Chemoradiation Therapy - Group II

ACTIVE COMPARATOR

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

Radiation: 3 Dimensional Conformal Radiation Therapy

Chemoradiation Therapy plus Propanolol

EXPERIMENTAL

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

Propranolol DRUG

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

Chemoradiation Therapy plus Propanolol

Intensity Modulated Radiation Therapy RADIATION

Undergo IMRT

Also known as: IMRT

Chemoradiation Therapy - Group I; Chemoradiation Therapy plus Propanolol

Paclitaxel DRUG

Given IV

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

Chemoradiation Therapy - Group I

Carboplatin DRUG

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

Chemoradiation Therapy - Group I

3 Dimensional Conformal Radiation Therapy RADIATION

Undergo 3D CRT

Also known as: 3D-CRT, Radiation

Chemoradiation Therapy - Group I; Chemoradiation Therapy - Group II; Chemoradiation Therapy plus Propanolol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

RECRUITING

MeSH Terms

Conditions

Adenocarcinoma Of Esophagus

Interventions

Carboplatin; Radiotherapy, Conformal; Radiation; Propranolol; propranolol CR; Radiotherapy, Intensity-Modulated; Paclitaxel; Taxes

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics; Physical Phenomena; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations

Study Officials

• Anurag Singh, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ASK RPCI

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: December 23, 2020
• Study Start: April 1, 2021
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

US (1)