Propranolol Plus Standard Radiation Therapy Before Surgery for the Treatment of Patients With Soft Tissue Sarcoma

Launched by ROSWELL PARK CANCER INSTITUTE · Oct 31, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the combination of a medication called propranolol with standard radiation therapy (RT) before surgery for patients with soft tissue sarcoma, a type of rare tumor that arises from connective tissue. The goal is to determine if adding propranolol, which is commonly used to treat high blood pressure, can make the radiation therapy more effective and safer for patients. The trial will look at how well patients tolerate this combination treatment and its potential benefits in shrinking tumors before surgery.

To participate in this trial, individuals must be at least 18 years old and have a specific type of soft tissue sarcoma that requires radiation therapy. They should be able to swallow medication and must agree to use birth control if they could become pregnant. However, some people may not be eligible, including those with certain health conditions or those who are pregnant or nursing. Participants in the trial will need to follow specific procedures and guidelines, and they will be closely monitored throughout the study to ensure their safety and well-being.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age ≥ 18 years old
• • Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
• • Eligible for curative-intent radiation therapy for a soft tissue extremity sarcoma
• • Ability to swallow and retain oral medication
• • Participants of child-bearing potential must 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:
• • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• • Known hypersensitivity to propranolol
• • Contraindication to 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 \< 85 or fasting plasma glucose \> 160 mg/dL at screening), symptomatic peripheral arterial disease or Raynaud's syndrome, untreated pheochromocytoma, current nondihydropyridines calcium channel blocker use (such as verapamil, diltiazem) or rhythm control agents such as digoxin and amiodarone. Patients with pacemakers will be excluded
• • Patients cannot be on propranolol and another beta-blocker simultaneously. Patients already on beta-blockers can (with approval and under supervision of their primary care physician and/or cardiologist) may choose to stop their current beta-blocker and switch to propranolol for the duration of the study
• • 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