Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Proportion of patients who experience major wound complications |
Will be estimated by the number of patients who experience the major wound complications within 120 days following surgery divided by the total number of evaluable patients. 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). 95% confidence intervals using normal approximation to binomial wound complication proportion will be calculated. |
Within 120 days of surgical resection of soft tissue sarcoma following preoperative radiation therapy |
|
| Secondary |
Local failure rate |
Will be defined 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 year divided by the total number of evaluable patients. Exact binomial 95% confidence interval for the point estimate will be provided. In the case of censoring prior to 5 years, LFR5 will be estimated using the Kaplan-Meier method. |
At 5 years |
|
| Secondary |
Disease-free survival |
The distribution of disease-free survival will be estimated using method of Kaplan-Meier. |
From registration date to the earliest date of documentation of either, local recurrence, regional recurrence, distant recurrence, or death due to any cause, assessed up to 5 years |
|
| Secondary |
Overall survival |
The distribution of overall survival will be estimated using method of Kaplan-Meier. |
From registration date to death due to any cause, assessed up to 5 years |
|
| Secondary |
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 event divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true rate of >= grade 2 late adverse events will be calculated. |
Between 3 months and 24 months after completion of hypofractionated preoperative radiation therapy |
|
| Secondary |
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 divided by the total number of evaluable patients. Exact binomial 95% confidence interval for the point estimate will be provided. |
Up to 5 years |
|
| Secondary |
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. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. |
Up to 5 years |
|
| Secondary |
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 Wilcoxon signed-rank test will be utilized to assess changes in raw PROMIS scores. Mean change, along with standard deviation will be reported. 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. |
Baseline up to 24 months post-surgery |
|
| Secondary |
Change in quality of life - TESS |
Results from the Toronto Extremity Salvage Score (TESS) questionnaire will be used to evaluate functional outcomes. Mean change from baseline to 24 months post-surgery, along with standard deviation will be reported by version. 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). |
Baseline up to 24 months post-surgery |
|
