drugset / Trial / NCT04031677
Surgery With or Without Neoadjuvant Chemotherapy in High Risk RetroPeritoneal Sarcoma
Phase 3
Recruiting
250 enrolled
European Organisation for Research and Treatment of Cancer - EORTC
Anticancer Fund, Belgium · collabAustralia and New Zealand Sarcoma Association · collabCanadian Cancer Trials Group · collabECOG-ACRIN Cancer Research Group · collabJapan Clinical Oncology Group · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a multicenter, randomized, open label phase lll trial to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of high risk DDLPS (dedifferentiated Liposarcoma) and LMS (Leiomyosarcoma) patients as measured by disease free survival. After confirmation of eligibility criteria, patients will be randomized to either the standard arm or experimental arm.
Timeline
- Start
- 2021-01-20
- Primary completion
- 2027-04-21
- Completion
- 2028-04-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Doxorubicin | Other / unclassified | 75 mg/m2 | — |
| Subject | Epirubicin | Small molecule | 120 mg/m2 | — |
| Subject | Ifosfamide | Small molecule | 9 g | — |
| Subject | Oxaliplatin | Small molecule | 1 g | — |