Propranolol With Standard Chemoradiation for Esophageal Adenocarcinoma

Esophageal Adenocarcinoma Clinical Trial

Official title:

Propranolol With Standard Chemoradiation for Esophageal Adenocarcinoma A Phase II Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04682158
• Other study ID #: I 630420
• Status: Recruiting
• Phase: Phase 2
• Start date: April 1, 2021
• Est. completion date: April 1, 2027

Study information

• Verified date: April 2024
• Source: Roswell Park Cancer Institute
• Contact: ASK RPCI
• Phone: 1-800-767-9355
• Email: askroswell[@]roswellpark.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 and will be considered separately as a single arm prospective cohort

Description:

PRIMARY OBJECTIVE: I. To determine the safety and efficacy of propranolol hydrochloride (propranolol) in combination with standard neoadjuvant/definitive chemoradiation therapy (CRT) for esophageal cancer. SECONDARY OBJECTIVE: I. To estimate overall survival (OS) and pathologic response rate in patients that undergo surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 106
• Est. completion date: April 1, 2027
• Est. primary completion date: April 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Esophageal Adenocarcinoma
• Esophageal Neoplasms

Intervention

Drug:
• Carboplatin
Given IV

Radiation:
• 3 Dimensional Conformal Radiation Therapy
Undergo 3D CRT

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

Radiation:
• Intensity Modulated Radiation Therapy
Undergo IMRT

Drug:
• Paclitaxel
Given IV

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of Adverse Events	To determine the safety and efficacy of the combination of propranolol plus chemoradiation	Up to 5 years
Primary	Progression Free Survival	Imaging findings from first radiation treatment to progression of disease	UP to 5 years
Secondary	Overall Survival	will be assessed by chart review of date of last follow-up or date of death	Up to 5 years