NCT06670976

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

Pilot Study of Soft Tissue Sarcoma Treated With Propranolol and Radiation

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase I trial tests the safety, tolerability and impact of adding propranolol to standard radiation therapy (RT) before surgery for the treatment of patients with soft tissue sarcoma. Sarcomas are a diverse group of rare tumors arising from connective tissue. Approximately 13,000-16,000 new cases of sarcomas arise in the United States annually. Sarcoma management involves multidisciplinary team decision making and treatment is multimodal utilizing chemotherapy (if needed) and RT prior to surgical intervention. Propranolol is a drug that has been used for many years for high blood pressure by blocking both beta-1 and beta-2 adrenergic receptors. Preclinical data suggests that blocking the beta-2 adrenergic receptors can improve the response to both chemotherapy and radiation. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. RT before surgery makes the tumor smaller and reduces the amount of tissue that needs to be removed during surgery. Surgery is the most common treatment for soft tissue sarcoma. Giving propranolol with standard RT before surgery may be safe, tolerable and impactful in treating patients with soft tissue carcinoma.

Detailed description

PRIMARY OBJECTIVE: I. To establish the safety and tolerability of adding propranolol to standard RT for soft tissue sarcoma. SECONDARY OBJECTIVE: I. To evaluate the response of tumor immune microenvironment to treatments for patients. OUTLINE: Patients receive propranolol orally (PO) twice daily (BID) for 2 weeks prior to standard of care RT (weeks 1 and 2) and then during and after standard of care RT (weeks 3-7). Treatment continues in the absence of disease progression or unacceptable toxicity until the time of standard of care surgery (week 8). Additionally, patients undergo positron emission tomography (PET) scan and/or computed tomography (CT) scan during screening and may undergo blood and tissue biopsy sample collection throughout the trial. After completion of study treatment, patients are followed up at 5 weeks.

Conditions

• Soft Tissue Sarcoma

Interventions

Type	Name	Description
PROCEDURE	Biopsy	Undergo tissue biopsy sample collection
PROCEDURE	Biospecimen Collection	Undergo blood sample collection
PROCEDURE	Computed Tomography	Undergo CT scan
PROCEDURE	Positron Emission Tomography	Undergo PET scan
DRUG	Propranolol	Given PO
RADIATION	Radiation Therapy	Undergo RT
PROCEDURE	Surgical Procedure	Undergo surgery

Timeline

• Start date: 2026-05-15
• Primary completion: 2029-11-15
• Completion: 2029-11-15
• First posted: 2024-11-01
• Last updated: 2025-08-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study