Pre-operative Hypofractionated Proton Therapy (PRONTO)
Status
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
40 participants in 1 patient group
Trial contacts and locations
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Central trial contact
Curtiland Deville, MD; Ryan Manuel
Data sourced from clinicaltrials.gov
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