Sequential Neoadjuvant Chemotherapy in Soft Tissue Sarcoma
Nearly half of patients with high-grade, localized soft tissue sarcoma (STS) of extremities and trunk wall develop disease recurrence after local therapy. Adjuvant chemotherapy with ifosfamide and doxorubicin may improve long-term disease-free survival, but the benefit of adjuvant treatment is limited and predictive fa
| Condition(s) | Soft Tissue Sarcoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | Nearly half of patients with high-grade, localized soft tissue sarcoma (STS) of extremities and trunk wall develop disease recurrence after local therapy. Adjuvant chemotherapy with ifosfamide and doxorubicin may improve long-term disease-free survival, but the benefit of adjuvant treatment is limited and predictive factors for treatment response are lacking. The aim of this study is to explore sequential treatment with ifosfamide and doxorubicin in a neoadjuvant setting and to investigate biomarkers predictive of treatment response. |
| Who can participate | Inclusion Criteria: 1. ≥ 18 years of age at the time of informed consent. 2. Histological diagnosis of soft tissue sarcoma belonging to one of the following histotypes: 1. Leiomyosarcoma 2. Malignant peripheral nerve sheath tumor 3. Undifferentiated pleomorphic sarcoma 4. Myxofibrosarcoma 5. Synovial sarcoma 6. Pleomorphic liposarcoma 7. Pleomorphic rhabdomyosarcoma 8. Unclassified spindle cell sarcoma 3. Malignancy grade ≥ 2 according to the Fédération Nationale des Centres de Lutte Contre le Cancer (FNCLCC) grading system. 4. Tumor localized in extremity, girdle and/or trunk wall. 5. Primary tumor size ≥5.0 cm as measured in the longest diameter on diagnostic MRI or CT scan. 6. Primary tumor location below the superficial fascia or involving the superficial fascia, i.e. deep-seated accor |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Oslo University Hospital |
| Locations | Bergen, Norway; Oslo, Norway |
| Start date | 2021-04-27 |
| NCT ID | NCT04776525 |
| Official listing | https://clinicaltrials.gov/study/NCT04776525 |