Propranolol Plus Standard Radiation Therapy Before Surgery for the Treatment of Patients With Soft Tissue Sarcoma
Key facts
- Who runs it
- Roswell Park Cancer Institute
- Where
- Buffalo, United StatesSee the site
- Trial code
- Status
- Withdrawn
- Phase
- Phase 1
- Started
- 15 May 2026
- Expected to end
- 15 Nov 2029
- Type of study
- Interventional
- Treatments tested
- Biopsy
- Biospecimen Collection
- Computed Tomography
- Positron Emission Tomography
- Propranolol
- Radiation Therapy
- Surgical Procedure
- Record updated
- 26 August 2025
- Why it stopped
- to be submitted at a later date
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug
- 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
Where in United States
- Roswell Park Cancer InstituteBuffalo, United States
About the trial
What the trial wants to find out
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.
The group in the trial
- Treatment (propranolol, RT, surgery)Treatment being tested
Patients receive propranolol PO 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 PET scan and/or CT scan during screening and may undergo blood and tissue biopsy sample collection throughout the trial.
Treatment: Biopsy, Biospecimen Collection, Computed Tomography, Positron Emission Tomography, Propranolol, Radiation Therapy, and Surgical Procedure
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Pilot Study of Soft Tissue Sarcoma Treated With Propranolol and Radiation
- Record updated
- 26 August 2025