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Proton Therapy for Soft Tissue Sarcoma

This study is looking at whether hypofractionated proton therapy (a type of radiation treatment given in fewer, larger doses) is safe and effective for adults with soft tissue sarcoma in their arms, legs, or trunk. You would receive five sessions of proton therapy before having surgery for your sarcoma. The main goal is to see how many people have major wound complications after surgery. We're also looking at how well you recover and your quality of life. The study aims to enroll 40 participants, but its current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 40 adult participants. It is designed to evaluate the safety and effectiveness of hypofractionated proton therapy.
What's involved
You would receive five sessions of proton therapy before surgery and complete questionnaires about your treatment and quality of life for about two years after surgery. You will also have standard follow-up appointments with your treatment team.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for about two years after surgery, with wound complications measured at 90 days after surgery.

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NCT05917301

Pre-operative Hypofractionated Proton Therapy

Recruiting
NAAges 18+InterventionalTreatment
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
~40 participants
Updated 2026-04-17 on ClinicalTrials.gov
What's tested:hypofractionation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of major wound complications
Measured over 90 days after surgery

Conditions

Soft Tissue Sarcoma

Explore related trials

Soft Tissue Sarcoma

Where it's being run

1 sites across 1 states
District of Columbia1

Study leadership

  • Curtland Deville, MD · PRINCIPAL_INVESTIGATOR · Johns Hopkins School of Medicine

Who to contact

Curtiland Deville, MD
[email protected]
202-537-4788
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adult patients (≥18 years of age)
Patients with primary or locally recurrent extremity or truncal soft tissue sarcoma
WHO/ECOG status ≤2

Exclusion

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.

What this trial measures

  • Rate of major wound complications90 days after surgery

    Number of major wound complications as defined by the CAN-NCIC-SR2 trial ("secondary operation under general or regional anaesthesia for wound repair (debridement, operative drainage, and secondary wound closure including rotationplasty, free flaps, or skin grafts), or wound management without secondary operation…\[including\] an invasive procedure without general or regional anaesthesia (mainly aspiration of seroma), readmission for wound care such as intravenous antibiotics, or persistent deep packing for 120 days or longer.")