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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
This study is being done to see if hypofractionation in treating sarcoma, will also provide patients with a faster and safer treatment outcome.
Sibley Memorial Hospital
Washington D.C., District of Columbia, United States
RECRUITINGRate of major wound complications
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.")
Time frame: 90 days after surgery
Incidence of acute grade ≥3 adverse events
Rate of acute grade 3 or higher adverse events (CTCAE5)
Time frame: 2 years after treatment
Rate of local recurrence free survival
Number of patients without local recurrence on CT and/or MRI at specified time points.
Time frame: 1 and 2 years after enrollment
Rate of metastasis free survival
Number of patients without metastasis on CT and/or MRI at specified time points.
Time frame: 1 and 2 years after enrollment
Rate of late grade ≥2 radiation toxicity
Rate of grade 2 or higher CTCAE5 adverse events associated with radiation therapy (fibrosis, lymphedema, or joint stiffness).
Time frame: median two year follow up
Musculoskeletal Tumor Rating Scale scores
The Musculoskeletal Tumor Rating Scale measures physical function in patients with musculoskeletal tumors. The total score for the MSTS ranges 0-30 with higher scores indicating better function.
Time frame: baseline, 2-12 weeks after end of radiation therapy, after surgery (3-6 month follow up), every 3 months during follow up for 2 years
Toronto Extremity Salvage Score (TESS) scores
The Toronto Extremity Salvage Score (TESS) measures physical function in patients with musculoskeletal tumors. The total score for the TESS ranges 0-100 with higher scores indicating better function.
Time frame: baseline, 2-12 weeks after end of radiation therapy, after surgery (3-6 month follow up), every 3 months during follow up for 2 years
Functional Assessment of Cancer Therapy-General (FACT-G) scores
The Functional Assessment of Cancer Therapy-General (FACT-G) measures quality of life for patients with cancer. The total score for the FACT-G ranges 0-108 with higher scores indicating better function.
Time frame: baseline, 2-12 weeks after end of radiation therapy, after surgery (3-6 month follow up), every 3 months during follow up for 2 years
Rate of pathologic complete response
Pathologic complete response rate is reported as the number of patients who achieve pathologic complete response after treatment. As per the NCCN guidelines, pathologic response is graded by the system recommended by the AJCC Cancer Staging Manual and CAP guidelines: Complete response - no remaining viable cancer cells Moderate response - only small clusters/single cancer cells remain Minimal response - residual cancer remaining, but with predominant fibrosis Poor response - minimal/no tumor kills, extensive residual cancer
Time frame: through study conclusion (estimated 5 years from opening)
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