Roswell Park Cancer Institute
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
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.
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.…
Given IV
Undergo 3D CRT
Subject will be treated with 30 mg po BID Propranolol for up to 6 weeks
Undergo IMRT
Given IV
Arctuva estimate
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