SATURN-STS: Phase II Study of Neoadjuvant Atezolizumab With Doxorubicin, Concurrent Atezol
The goal of this clinical research study is to look at the effectiveness of giving a combination of chemotherapy, immunotherapy, radiation therapy, and surgery to treat soft tissue sarcomas that can be removed by surgery. Researchers want to find out if this treatment combination can extend the time it takes for the di
| Condition(s) | Soft Tissue Sarcoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | The goal of this clinical research study is to look at the effectiveness of giving a combination of chemotherapy, immunotherapy, radiation therapy, and surgery to treat soft tissue sarcomas that can be removed by surgery. Researchers want to find out if this treatment combination can extend the time it takes for the disease to relapse (come back after treatment). The safety of this treatment combination will also be studied. |
| Who can participate | Inclusion Criteria: * Adult subjects (Age ≥18 years) with treatment-naïve de novo or locally recurrent soft tissue sarcomas of the extremity or superficial trunk * Histological diagnosis of grade 2 or grade 3 undifferentiated pleomorphic sarcoma (UPS), myxofibrosarcoma (MFS), de-differentiated/pleomorphic liposarcoma (DDLPS), unclassified sarcoma, and leiomyosarcoma. Pathologic terms for the "unclassified sarcoma" histology may include pleomorphic undifferentiated sarcoma, unclassified spindle cell sarcoma, spindle cell sarcoma not otherwise specified, pleomorphic spindle cell sarcoma, or pleomorphic fibroblastic sarcoma. * Patient must have recent imaging (CT or MRI, as appropriate) within 8 weeks of trial enrollment demonstrating measurable disease, defined as at least one lesion that ca |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | M.D. Anderson Cancer Center |
| Locations | Houston, Texas, United States |
| Start date | 2025-09-11 |
| NCT ID | NCT07049848 |
| Official listing | https://clinicaltrials.gov/study/NCT07049848 |