PROspective Phase II Trial of Pre-operative Hypofractionated protoN Therapy for Extremity and Truncal Soft Tissue sarcOma
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.
Arms & interventions
- Radiationhypofractionation
This study is being done to see if hypofractionation in treating sarcoma, will also provide patients with a faster and safer treatment outcome.
Outcome measures
Primary
Rate 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
Secondary
Incidence of acute grade ≥3 adverse events
Time frame: 2 years after treatment
Rate of local recurrence free survival
Time frame: 1 and 2 years after enrollment
Rate of metastasis free survival
Time frame: 1 and 2 years after enrollment
Rate of late grade ≥2 radiation toxicity
Time frame: median two year follow up
Musculoskeletal Tumor Rating Scale scores
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
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
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
Time frame: through study conclusion (estimated 5 years from opening)
Eligibility criteria
Study locations (1)
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
References
- Gogineni E, Chen H, Hu C, Boudadi K, Engle J, Levine A, Deville C Jr. Prospective phase II trial of preoperative hypofractionated proton therapy for extremity and truncal soft tissue sarcoma: the PRONTO study rationale and design. Radiat Oncol. 2024 May 14;19(1):56. doi: 10.1186/s13014-024-02447-0.(PubMed)