This phase II trial investigates the effects of hypofractionated radiation therapy before surgery on wound complications associated with surgery in treating patients with soft tissue sarcoma of the extremity (arms, hands, legs or feet) and superficial trunk that has not spread to other parts of the body (localized) and can be removed by surgery (resectable). Hypofractionated is a shorter radiation therapy treatment length (fewer radiation treatment days) and administers the total radiation dose as larger daily doses, compared to conventionally fractionated therapy.
PRIMARY OBJECTIVE: I. To report the major acute wound complication rate associated with hypofractionated preoperative radiation therapy, 42.75 Gy in 15 fractions. SECONDARY OBJECTIVES: I. To report the 5-year local failure rate associated with hypofractionated preoperative radiation therapy, 42.75 Gy in 15 fractions. II. To report the 5-year disease-free survival rate associated with hypofractionated preoperative radiation therapy, 42.75 Gy in 15 fractions. III. To report the 5-year overall survival rate associated with hypofractionated preoperative radiation therapy, 42.75 Gy in 15 fractions. IV. To report long-term toxicity rates associated with hypofractionated preoperative radiation therapy, 42.75 Gy in 15 fractions. V. To describe patterns of relapse associated with hypofractionated preoperative radiation therapy, 42.75 Gy in 15 fractions. VI. To describe patient reported outcomes/quality-of-life outcomes with hypofractionated preoperative radiation therapy, 42.75 Gy in 15 fractions. OUTLINE: Patients undergo hypofractionated radiation therapy once daily (QD) (except weekends and holidays) over 3 weeks for a total of 15 fractions. Within 3-6 weeks after completion of radiation therapy, patients undergo surgical resection. After completion of study treatment, patients are followed up at 4-8 weeks, every 3-4 months for years 1-2, and every 6 months for years 3-5.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Undergo hypofractionated radiation therapy
Ancillary studies
Ancillary studies
Undergo surgical resection
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Major Wound Complications
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).
Time frame: Within 120 days of surgical resection of soft tissue sarcoma following preoperative radiation therapy
Local Failure Rate
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.
Time frame: Up to 1 year
Percent Probability of Disease-free Survival at 1 Year
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
Time frame: up to 1 year
Percent Probability of Overall Survival at 1 Year
Defined as the time from registration date to death due to any cause
Time frame: Up to 1 year
Incidence of Late Adverse Events
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.
Time frame: Between 3 months and 24 months after completion of hypofractionated preoperative radiation therapy
Pattern of Relapse
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.
Time frame: Up to 1 years
Incidence of Adverse Events
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.
Time frame: Up to 1 year
Change in Quality of Life - PROMIS-10
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.
Time frame: Baseline up to 24 months post-surgery
Change in Quality of Life - TESS
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).
Time frame: Baseline up to 24 months post-surgery
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