NCT04682158

Propranolol With Standard Chemoradiation for Esophageal Adenocarcinoma

Propranolol With Standard Chemoradiation for Esophageal Adenocarcinoma A Phase II Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 106 (estimated)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Esophageal Adenocarcinoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-04-01
• Primary completion: 2029-04-01
• Completion: 2029-04-01
• First posted: 2020-12-23
• Last updated: 2026-01-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study