Propranolol With Standard Chemoradiation for Esophageal Adenocarcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Carboplatin, 3 Dimensional Conformal Radiation Therapy, Propranolol, Intensity Modulated Radiation Therapy.
- Who it may be relevant to
- Registry conditions: Esophageal Adenocarcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Propranolol With Standard Chemoradiation for Esophageal Adenocarcinoma A Phase II Study
Overview
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
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.
Interventions
- 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
Primary outcome measures
- Occurrence of Adverse Events [Time frame: Up to 5 years]
- Progression Free Survival [Time frame: UP to 5 years]
Secondary outcome measures (1)
- Overall Survival [Time frame: Up to 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Roswell Park Cancer Institute — Buffalo
Identifiers
NCT: NCT04682158 · I 630420