Pre-operative proton therapy for soft tissue sarcoma
Official title: PROspective Phase II Trial of Pre-operative Hypofractionated protoN Therapy for Extremity and Truncal Soft Tissue sarcOma
Run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · NCT05917301 · Data updated 2026-11-12
This study tests if a special type of radiation therapy given before surgery can help people with soft tissue sarcomas in their arms or legs heal better and have a better quality of life afterward.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Status | Recruiting |
| Started | April 18, 2024 |
| Main results expected | December 2030 |
| Study ends | December 2032 |
| Registry record updated | April 17, 2026 |
| Trial ID | NCT05917301 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with primary or locally recurrent extremity or truncal soft tissue sarcoma.
✕Probably not a fit
Patients with a history of prior local radiation therapy or those requiring systemic therapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study examines the safety and effectiveness of hypofractionated proton therapy for patients with extremity and trunk soft tissue sarcomas before they undergo surgery. Participants will receive five fractions of proton therapy, and the study will assess wound complications and functional outcomes, including quality of life, through questionnaires over a two-year period post-surgery. Standard care follow-ups will also be conducted to monitor patient progress.
Why it matters
Potential benefit: If successful, this approach could improve surgical outcomes and quality of life for patients with soft tissue sarcoma.
How similar studies have gone: Other studies have shown promise with proton therapy for various cancers, suggesting potential success for this approach in treating soft tissue sarcoma.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (≥18 years of age) * Patients with primary or locally recurrent extremity or truncal soft tissue sarcoma * WHO/ECOG status ≤2 Exclusion Criteria: * History of prior local radiation therapy * Inability to tolerate treatment position for duration of simulation or treatment * Tumor originating in retroperitoneal location * Patients planned for systemic therapy including chemotherapy, targeted agents, and immunotherapy * Co-existing malignancy or treated malignancy in the last 2 years expected to limit life expectancy; does not include completely resected cutaneous basal cell carcinoma, squamous cell carcinoma, in situ breast or cervical malignancies, or other pathologies at the discretion of the investigators. * Confirmed pregnancy.
Where it's running
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Sibley Memorial Hospital
Washington D.C., District of Columbia, United States Recruiting
Study contacts
- Principal investigator: Curtland Deville, MD — Johns Hopkins School of Medicine
- Study coordinator: Curtiland Deville, MD
- Email: cdeville@jhmi.edu
- Phone: 202-537-4788
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.