Trial Outcomes & Findings for Radiation Therapy Before Surgery for Localized, Resectable Soft Tissue Sarcoma of the Extremity and Superficial Trunk (NCT NCT04562480)

Radiation Therapy Before Surgery for Localized, Resectable Soft Tissue Sarcoma of the Extremity and Superficial Trunk

Will be assessed by the number of patients who experience major wound complications within 120 days following surgery. Major wound complication is defined as secondary unplanned operation under general or regional anesthesia for wound repair (e.g., debridement, operative drainage, or secondary wound closure including rotationplasty, free flaps or skin grafts); or wound management without secondary operation including invasive procedures (e.g., aspiration of seroma or readmission for wound care such as intravenous antibiotics or persistent deep packing for 120 days or longer).

Defined as any radiographic or pathologic evidence of recurrent disease inside the clinical target volume (CTV) and/ or to within 3 cm from the edge of the CTV. Local failure rate at 5 years (LFR5) will be evaluated by the number of patients free of local failure/recurrence at 5 years.

Defined as the time from registration to the earliest date of documentation of local recurrence, regional recurrence, distant recurrence, or death due to any cause

Defined as the time from registration date to death due to any cause

The descriptions and grading scales found in the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for adverse event reporting. The rate of \>= grade 2 late adverse events will be estimated by the number of patients with a \>= grade 2 late adverse events.

Pattern of relapse will be evaluated by number of patients with patterns of tumor recurrence such as local recurrence, marginal recurrence, regional recurrence, distant metastasis, and second primary tumor.

The descriptions and grading scales found in the revised NCI CTCAE version 5.0 will be utilized for adverse event reporting. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns.

Results from the ten-item Patient Reported Outcomes Measurement Information System (PROMIS-10) questionnaire will be used to evaluate physical and mental health separately. The PROMIS-10 consists of ten items that measure physical health, physical functioning, general mental health, emotional distress, satisfaction with social activities and relationships, ability to carry out usual social activities and roles, pain, fatigue and overall quality of life.

Results from the Toronto Extremity Salvage Score (TESS) questionnaire will be used to evaluate functional outcomes. The TESS was designed as a measure of the difficulty patients have performing routine daily activities. It consists of 31 items with responses from 1 (impossible to do) to 5 (not at all difficult).