Clinical Trial Radar

Incidence and type of acute major wound complications

Incidence and type of acute major wound complications: One or more of the following events occurring within 4 months of index sarcoma surgery including: 1). A secondary operation under general or regional anesthesia for wound repair (debridement, operative drainage, and secondary wound closure including rotationplasty, free flaps, or skin grafts), 2). Wound management without secondary operation, such, An invasive procedure without general or regional anesthesia (such as aspiration of seroma), Readmission for wound care such as intravenous antibiotics, or Persistent deep packing for 120 days or longer.

Up to 24 months

1-year Local control

Local control is defined as the proportion of patients without clinical evidence of local recurrence. This will be reported as will a cumulative incidence curve of local failures, considering using death as a competing risk, using the cumulative incidence function method.

At 1 year

2-year Local control

Local control is defined as the proportion of patients without clinical evidence of local recurrence. This will be reported as will a cumulative incidence curve of local failures, considering using death as a competing risk, using the cumulative incidence function method.

At 2 years

Progression-free survival (PFS)

Median number of months from start of treatment until the date of disease progression or death from any cause.

Up to 24 months

Overall survival (OS)

Median number of months from start of treatment until death from any cause.

Up to 24 months

Musculoskeletal Tumour Society Score [MSTS]

The MSTS is a patient questionnaire for assessing physical function after medical treatment, surgery, and physiotherapy in patients with malignant bone tumors in specific extremities. The MSTS questionnaire consists of six domains, each scored on a scale from 0 to 5, with a higher score indicating better function. The total score, ranging from 0 (maximum disability) to 30 (no impairment), can be transformed to a point scale of 0 to 100.

Up to 24 months

Toronto Extremity Salvage Score [TESS]

TESS represents the gold standard for assessing function after surgery for muscle and bone tumors, as it has been tested for validity and reliability, and extremity-specifically defines disability, handicap, change in physical function depending on the therapeutic intervention and the patient's need for an aid. The TESS questionnaire has both upper and lower extremity versions. Twenty-nine items are rated on a scale from one to five, with five representing normal activity. The result ranges from 0 to 100, with 100 being the best score.

Up to 24 months

Adverse Events and Serious Adverse Events related to intervention(s)

Adverse Events and Serious Adverse Events per CTCAE v5.0 that attributed to study intervention(s).

Up to 24 months

Frequency of late toxicities

Acute toxicities are defined as toxicity occurring during preoperative RT, after RT and prior to surgery, and within 90 days of index resection, assessed using CTCAE v5.0.

Up to 24 months

Change in type of actual surgical closures

Tabulation of the initial surgical closure intended, and the actual surgical closure used at the time of index resection. Descriptive statistics will be used to summarize these assessments.

At surgery