drugset / Trial / NCT03805022
Benefit of Intensified Peri-operative Chemotherapy Within High-risk CINSARC Patients With Resectable Soft-tissue Sarcomas
RandomizedParallel-groupOpen-labelTreatment
Summary
The primary objective of this trial is to investigate whether the addition of 3 additional neo-adjuvant cycles of chemotherapy (doxorubicin based chemotherapy) to standard management according to the ISG-STS 10-01 study (3 cycles of neoadjuvant doxorubicin based chemotherapy + surgery +/- radiotherapy) improves the outcome of high-risk CINSARC patients with resectable soft-tissue sarcoma (STS). Primary endpoint is metastatic progression-free survival (M-PFS, after 3 years of follow-up).
Timeline
- Start
- 2019-02-14
- Primary completion
- 2026-12
- Completion
- 2028-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dacarbazine | Small molecule | 100 mg/m2 | — |
| Subject | Dacarbazine | Small molecule | 450 mg/m2 | — |
| Subject | Doxorubicin | Other / unclassified | 20 mg/m2 | — |
| Subject | Doxorubicin | Other / unclassified | 25 mg/m2 | — |
| Subject | Doxorubicin | Other / unclassified | 60 mg/m2 | — |
| Subject | Doxorubicin | Other / unclassified | 75 mg/m2 | — |
| Subject | Ifosfamide | Small molecule | 7.5 g | — |
| Subject | Ifosfamide | Small molecule | 9 g | — |