Pre-operative Hypofractionated Proton Therapy

Last updated: April 9, 2025
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Overall Status: Active - Recruiting

Phase

N/A

Condition

Soft Tissue Sarcoma

Sarcoma (Pediatric)

Sarcoma

Treatment

hypofractionation

Clinical Study ID

NCT05917301
SIB2289
IRB00335181
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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, andimmunotherapy

  • Co-existing malignancy or treated malignancy in the last 2 years expected to limitlife expectancy; does not include completely resected cutaneous basal cellcarcinoma, squamous cell carcinoma, in situ breast or cervical malignancies, orother pathologies at the discretion of the investigators.

  • Confirmed pregnancy.

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: hypofractionation
Phase:
Study Start date:
April 18, 2024
Estimated Completion Date:
December 31, 2032

Connect with a study center

  • Sibley Memorial Hospital

    Washington, District of Columbia 20016
    United States

    Active - Recruiting

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