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Pre-operative Hypofractionated Proton Therapy
PROspective Phase II Trial of Pre-operative Hypofractionated protoN Therapy for Extremity and Truncal Soft Tissue sarcOma
Who can join
Ages 18 and older · All sexes
Full eligibility 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.
About the study
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.
What is being tested
- hypofractionation (radiation)
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Participants: 40 · Started: Apr 18, 2024
Contact the study team
- Curtiland Deville, MD · Phone: 202-537-4788
Official record on ClinicalTrials.gov — NCT05917301
Locations in the U.S.
| District of Columbia | Sibley Memorial Hospital, Washington D.C. |
Conditions
From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.