RecruitingNot ApplicableNCT05917301

Pre-operative Hypofractionated Proton Therapy

PROspective Phase II Trial of Pre-operative Hypofractionated protoN Therapy for Extremity and Truncal Soft Tissue sarcOma

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Enrollment

40 participants

Start Date

Apr 18, 2024

Study Type

INTERVENTIONAL

Conditions

Soft Tissue Sarcoma

Summary

This study is being done to examine whether proton therapy for certain kinds of sarcomas (extremity and trunk soft tissue) is safe and effective. As part of the study, patients will have five fractions of proton therapy before the participants have surgery for the sarcoma. The study will measure wound complications and functional outcomes / quality of life after the procedures. Patients will be asked to complete questionnaires about the treatment and quality of life from the time of enrollment until about two years after surgery. Otherwise, the participants will have standard of care follow ups with the treatment team.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing proton radiation therapy given before surgery in patients with soft tissue sarcoma (a cancer of muscles, fat, or connective tissue) located in the limbs or trunk — to see if it is effective and reduces side effects compared to standard radiation. **You may be eligible if...** - You are 18 or older - You have a primary or locally recurrent soft tissue sarcoma in a limb or the trunk - Your general health is good (ECOG/WHO status 0–2) - You are scheduled for surgical removal of the tumor **You may NOT be eligible if...** - You have had prior radiation to the same area - Your sarcoma is located in the retroperitoneum (back of the abdomen) - You are planned to receive systemic therapy (chemotherapy) concurrently - You are unable to maintain the required position during radiation treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

RADIATIONhypofractionation

This study is being done to see if hypofractionation in treating sarcoma, will also provide patients with a faster and safer treatment outcome.

Locations(1)

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05917301

Related Trials

Novel RNA-lipid Particle (RNA-LP) Vaccine for Anti-PD-1 Antibody Therapy Sensitization

NCT052649741 location

Efficacy and Safety of Envafolimab Plus Doxorubicin and Ifosfamide for Advanced Soft Tissue Sarcoma

NCT072436261 location

Study of ADI-PEG 20 or Placebo Plus Gem and Doc in Previously Treated Subjects With Leiomyosarcoma (ARGSARC)

NCT0571269431 locations

Retifanlimab (Anti-PD-1 Antibody) With Gemcitabine and Docetaxel in Patients With Advanced Soft Tissue Sarcoma

NCT045770141 location

B7-H3-Specific Chimeric Antigen Receptor Autologous T-Cell Therapy for Pediatric Patients With Solid Tumors (3CAR)

NCT048973211 location