COMPASS: COMparison of Self-reported Tolerability with Pazopanib Versus Chemotherapy among Patients with Advanced Soft Tissue Sarcoma in the United States

Trial description: The chemotherapies used to treat advanced soft tissue sarcoma (STS) are associated with burdensome adverse events (AEs). Most currently available information about the frequency and severity of AEs comes from the physician’s perspective, as captured in clinical trials. Multiple studies have demonstrated that collecting symptom data directly from patients using patient reported outcomes (PRO) instruments can improve the accuracy and efficiency of symptomatic AE data collection. Studies suggest that both physicians and nurses often underestimate the onset, frequency, and severity of AEs compared with patient ratings. The primary endpoint of the study is patient-reported tolerability as derived from responses to how bothered patients are by side effects of treatment. This question has 5 levels rated from 0 to 4, with larger values indicating a greater degree of bother. The proportions of patients with a score ≥ 3 (3 = “Quite a bit” or 4 =“Very much”) will be compared to the proportion with a score < 3. The primary hypothesis is that the proportion of patients with score ≥ 3 will be lower in the pazopanib group than in the chemotherapy group. The corresponding null hypothesis is that the proportions are equal in the pazopanib and chemotherapy groups.The data source for this study is the Sarcoma Patient Registry of the Sarcoma Foundation of America (SFA). The study population will consist of registered adult subjects with a diagnosis of advanced/metastatic STS who are receiving second-line or subsequent lines of treatment with either pazopanib or chemotherapy.