Stage III Soft Tissue Sarcoma of the Trunk and Extremities AJCC v8 Clinical Trial
Official title:
Evaluating the Impact of Limited vs. Intense Post-Operative Surveillance on Patient-Reported Outcomes in Patients With Soft Tissue Sarcoma
This phase II trial studies how anxiety is affected by 2 types of follow-up after surgery, limited follow-up and intense follow-up, in patients with stage II-III soft tissue sarcoma of the trunk and extremities. In cancer survivors, the fear of cancer coming back (recurring) is common and may persist long after the end of treatment. It may also be exacerbated by return visits for imaging (surveillance). The purpose of this study is to determine how patients' anxiety and other cancer-related outcomes are affected by how often surveillance is done.
PRIMARY OBJECTIVE: I. To evaluate whether a risk-based limited follow-up surveillance is associated with reduced patient anxiety compared to risk-based intense surveillance. SECONDARY OBJECTIVE: I. To evaluate the impact of reduced surveillance in low-risk patients on overall survival, time to local or distant recurrence, anxiety at early and late time-points, out of pocket costs, and number of missed or extra clinic visits, compared to the risk-based intense follow-up in both low-risk and high-risk patients. OUTLINE: Patients are assigned to 1 of 2 groups based on risk status. GROUP 1 (LOW RISK): Patients are randomized to 1 of 2 arms. ARM I: Patients undergo intense follow-up every 3 months for 2 years consisting of restaging with computed tomography (CT)-chest and imaging of the primary site. ARM II: Patients undergo limited follow-up every 6 months for 2 years consisting of restaging with either CT-chest or chest x-ray (CXR) and imaging of the primary site. GROUP 2 (HIGH RISK): Patients undergo intense follow-up every 3 months for 2 years as in Group 1, Arm I. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04420975 -
Nivolumab and BO-112 Before Surgery for the Treatment of Resectable Soft Tissue Sarcoma
|
Phase 1 | |
| Recruiting |
NCT05694871 -
Testing the Addition of Cemiplimab to Palbociclib for the Treatment of Advanced Dedifferentiated Liposarcoma
|
Phase 2 | |
| Not yet recruiting |
NCT06422806 -
Measuring if Immunotherapy Plus Chemotherapy is Better Than Chemotherapy Alone for Patients With Aggressive Poorly Differentiated Sarcomas
|
Phase 2 | |
| Terminated |
NCT03727789 -
CBL0137 in Treating Patients With Advanced Extremity Melanoma or Sarcoma
|
Phase 1 | |
| Active, not recruiting |
NCT03819985 -
Shorter Course, Hypofractionated Pre-Surgery Radiation Therapy in Treating Patients With Localized, Resectable Soft Tissue Sarcoma of the Extremity of Superficial Trunk
|
Phase 2 |