NCT05917301Recruiting
Pre-operative Hypofractionated Proton Therapy
PROspective Phase II Trial of Pre-operative Hypofractionated protoN Therapy for Extremity and Truncal Soft Tissue sarcOma
Source: ClinicalTrials.gov · Last updated 17 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 1 Jun 2023
- Start date
- 18 Apr 2024
- Primary completion date
- Dec 2030
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Diseases
- Sarcoma
- NCT number
- NCT05917301
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 18 Apr 2024 to the primary completion date, Dec 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of prior local radiation therapy
- Patients planned for systemic therapy including chemotherapy, targeted agents, and immunotherapy
Other illness
- 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.
Other
- Inability to tolerate treatment position for duration of simulation or treatment
- Tumor originating in retroperitoneal location
- Confirmed pregnancy.
Who the study is looking for
- Adult patients (≥18 years of age)
- Patients with primary or locally recurrent extremity or truncal soft tissue sarcoma
- WHO/ECOG status ≤2
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sibley Memorial Hospital Coordinator of this site? Confirm its status | Washington D.C. | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.