Recruiting

Hypofractionated Proton TherapyPre-operative Hypofractionated Proton Therapy

Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Code:

NCT05917301

Conditions

Soft Tissue Sarcoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

hypofractionation

Study Details

Brief 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.

Conditions

Soft Tissue Sarcoma

Study ID

NCT05917301

Start date

Apr 18, 2024

Status verified date

Apr, 2026

Completion date

Dec, 2032

Anticipated

Primary completion date

Dec, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pre-operative hypofractionated proton therapy

Patients will have 5 fractions of proton therapy prior to surgical resection of their sarcoma.

Interventions

hypofractionation

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

Primary outcome measure

Rate of major wound complications [ Time Frame: 90 days after surgery ]

Central Contacts and Locations

Central contacts

Curtiland Deville, MD

202-537-4788 cdeville@jhmi.edu

Ryan Manuel

rmanuel5@jhmi.edu

Locations

Sibley Memorial Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20016

Contacts

Curtiland Deville, MD

202-537-4788 cdeville@jhmi.edu

Dana Kaplin

410-614-3950 dkaplin1@jhmi.edu

More Information

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Last update posted

Apr 17, 2026

Last verified

Apr, 2026

Keywords

proton therapy
soft tissue sarcoma
hypofractionated

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins on 2026-04-17.