Gustavo Viani: Promising Results from Phase II Bladder Cancer Radiotherapy Trial with DART
Gustavo Viani shared on LinkedIn:
“Low Toxicity, High Survival: Promising Results from Phase II Bladder Cancer Radiotherapy Trial with Dose-escalated adaptive radiotherapy (DART)‼️
Objective: Assess the safety of dose-escalated adaptive image-guided radiotherapy (DART) for bladder cancer
Trial Design: Ph II international, non-comparative randomized controlled trial
Participants: 345 participants with T2-T4a urothelial bladder cancer
Randomized into three groups:
• Standard whole bladder radiotherapy (WBRT)
• Standard-dose adaptive radiotherapy (SART)
• Dose-escalated adaptive radiotherapy (DART)
Treatment Protocol:
WBRT and SART: 55 Gy/20 fractions (f) or 64 Gy/32f
• DART: 60 Gy/20f or 70 Gy/32f
• Daily adaptive plan based on bladder size (small, medium, large)
Endpoint: % with radiotherapy-related late G ≥3 toxicity
• Designed to rule out >20% toxicity in DART group
Key Findings:
• Low toxicity: Only 1/58 (1.7%) patients with 20f DART reported G ≥3 toxicity; none reported with 32f DART
• High adherence to mandatory dose constraints: 86%-90% of participants met the required medium plan.
• 2- year overall survival rates:
• WBRT + SART: 77%
• DART: 80%”
Author: Robert Huddart, Shaista Hafeez, Clare Griffin, Ananya Choudhury, Farshad Foroudi, Isabel Syndikus, Benjamin Hindson, Amanda Webster, Helen McNair, Alison Birtle, Mohini Varughese, Ann Henry, Duncan B McLaren, Omi Parikh, Ashok Nikapota, Colin Tang, Emma Patel, Elizabeth Miles, Karole Warren-Oseni, Tomas Kron, Courtney Hill, Lara Philipps, Catalina Vassallo-Bonner, Ka Ching Cheung, Hannah Gribble, Rebecca Lewis, Emma Hall
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