Table 4 The table summarizes currently ongoing and recruiting trials on preoperative hypofractionated radiotherapy for soft tissue sarcoma
From: Preoperative hypofractionated radiotherapy for soft tissue sarcomas: a systematic review
NCT number/phase | Title | RTX fraction × dose | Outcome measures | Dates | Center |
|---|---|---|---|---|---|
NCT05109494/Phase II | Hypofractionated vs Conventional Fractionated RT in Soft Tissue Sarcomas | 25 × 2 Gy = 50 Gy vs 5 × 5.5 Gy = 27.5 Gy | 1°: Pathological necrosis 2°: Surgical margins, WC, late toxicity, PFS, LR | Start: December 2021 Study completion: November 2026 | University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States |
NCT04425967/Phase II | Short Course Of Preoperative Radiotherapy in Head and Neck-, Trunk- and Extremity Soft Tissue Sarcomas | 25 × 2 Gy = 50 Gy vs 14 × 3 = 42 Gy | 1°: Acute toxicity (30 days post op) 2°: LC, late toxicity (2 years) | Start: June 2021 Study completion: April 2034 | Universitair Medisch Centrum Groningen, Groningen, Netherlands Leids Universitair Medisch Centrum, Leiden, Netherlands Radboudumc, Nijmegen, Netherlands |
NCT04562480/Phase II | Hypofractionated Radiation Therapy Before Surgery for the Treatment of Localized, Resectable Soft Tissue Sarcoma of the Extremity and Superficial Trunk | 15 × 2.85 Gy = 42.75 Gy | 1°: Major WC (within 120 days) 2°: LR, DFS, OS, late toxicity, pattern of relapse, QoL changes | Start: November 2020 Study completion: November 2026 | Mayo Clinic in Rochester, Rochester, Minnesota, United States |
NCT03819985/Phase II | Shorter Course, Hypofractionated Pre-Surgery Radiation Therapy in Treating Patients With Localized, Resectable Soft Tissue Sarcoma of the Extremity of Superficial Trunk | 15 × 2.85 Gy = 42.75 Gy vs 25 × 2 Gy = 50 Gy (historical control) | 1°: Non-inferiority design for time till major WC (within 120 days) 2°: LRFS, DFS, Time to relapse, Disease specific survival time, pattern of local relapse, acute toxicity other than WC, late toxicity, functional outcomes, QoL | Start: December 2018 Study completion: August 2023 | MD Anderson Cancer Center, Houston, Texas, United States |
NCT04617327/Phase I/II | Pre-operative RadiothErapy for Soft Tissue SarcOmas (PRESTO) | 5 × 7 Gy = 35 Gy every other day (3 fractions per week) | 1°: Acute toxicity (within 1 month) according to CTCAE V.5 2°: Performance measure by Physicians Muscle Tumor Rating Scale | Start: June 2020 Study completion: December 2027 | McGill University Health Centre-Cedars Cancer Centre, Montréal, Quebec, Canada |
NCT03972930/Phase II | Hypofractionated Radiotherapy for Soft Tissue Sarcomas | Highly conformal RT in 3–8 fractions maximum prescribed dose, total of 60 Gy in ≤ 8 weeks | 1°: LC (2-year) 2°: LC (5-year), CR-rate, PFS, OS, acute toxicity, late toxicity | Start: June 2019 Study completion: July 2026 | University of Wisconsin, Madison, Wisconsin, United States |
NCT04946357/Phase II | Neoadjuvant Irradiation of Extremity Soft Tissue Sarcoma With Ions (EXTREM ION) | Proton: 13 × 3 Gy = 39 Gy (RBE) vs Carbon ion: 13 × 3 Gy = 39 Gy (RBE) | 1°: Absence of wound healing disorders (till 120 days after surgery) 2°: LC, LPFS, DFS, OS | Start: June 2021 Study completion: July 2023 | University Hospital Heidelberg, Heidelberg, Germany |
NCT02634710/Phase II | Hypofractionated Pre-operative Radiation Therapy for Soft Tissue Sarcomas of the Extremity and Chest-wall | 5 × 7 Gy = 35 Gy every other day | 1°: LC (2 year) 2°: Serious adverse events (CTCAE V.4.0), Musculoskeletal Tumor Rating Scale Score, QoL, DFS, OS, radiological changes (T2 MRI), pathological changes | Start: February 2016 Study completion: December 2025 | Froedtert Hospital, Milwaukee, Wisconsin, United States |