Pre-operative Hypofractionated Proton Therapy

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT05917301
Status
Recruiting
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Conditions

  • Soft Tissue Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Apr 18, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2032

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pre-operative hypofractionated proton therapy
    Patients will have 5 fractions of proton therapy prior to surgical resection of their sarcoma.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Sibley Memorial HospitalWashington D.C.District of Columbia20016
Curtiland Deville, MD
[email protected]
202-537-4788
Dana Kaplin
[email protected]
410-614-3950

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By research site
Sibley Memorial Hospital· Washington D.C., DC

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