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Pre-operative Hypofractionated Proton Therapy

Pre-operative Hypofractionated Proton Therapy

Recruiting
18 years and older
All
Phase N/A

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Overview

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

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 details
    Soft Tissue Sarcoma

NCT05917301

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

22 April 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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