NCT04682158 Propranolol With Standard Chemoradiation for Esophageal Adenocarcinoma
| NCT ID | NCT04682158 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Roswell Park Cancer Institute |
| Condition | Esophageal Adenocarcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 106 participants |
| Start Date | 2021-04-01 |
| Primary Completion | 2029-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 106 participants in total. It began in 2021-04-01 with a primary completion date of 2029-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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
Contact & Investigator
Anurag Singh, MD
PRINCIPAL INVESTIGATOR
Roswell Park Cancer Institute
Frequently Asked Questions
Who can join the NCT04682158 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Esophageal Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04682158 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04682158 currently recruiting?
Yes, NCT04682158 is actively recruiting participants. Contact the research team at askroswell@roswellpark.org for enrollment information.
Where is the NCT04682158 trial being conducted?
This trial is being conducted at Buffalo, United States.
Who is sponsoring the NCT04682158 clinical trial?
NCT04682158 is sponsored by Roswell Park Cancer Institute. The principal investigator is Anurag Singh, MD at Roswell Park Cancer Institute. The trial plans to enroll 106 participants.