Daily Online Adaptive Radiation Therapy of Bladder Cancer for Reduction of Intestinal Toxicity: A Prospective Trial Using an Individualized Approach and Conventional Fractionation (ARTIA-Vesica)
This is a single-arm, prospective, Phase II, multi-center clinical trial designed to demonstrate that adaptive radiotherapy for muscle invasive bladder cancer will translate into a decreased rate of acute gastrointestinal toxicity compared with the historically reported rate for non-adaptive intensity modulated radiation therapy (IMRT).
• Histologically proven bladder cancer
• Urothelial carcinoma
• Age ≥ 18 years
• Stage T1b-T4AN0M0
• TUR-B and PET-CT or CT of thorax/abdomen/pelvis within 8 weeks prior to inclusion
• Suitable for radiotherapy
• ECOG/WHO performance status 0-2
• Written informed consent
• For Cohort B, participant's must have normal organ and marrow function as defined below:
‣ leukocytes ≥2,500/mcL
⁃ absolute neutrophil count ≥1,500/mcL
⁃ platelets ≥100,000/mcL
⁃ hemoglobin ≥9 g/dL
⁃ total bilirubin ≤ 1,5 ULN
⁃ AST(SGOT)/ALT(SGPT) ≤3 × ULN
⁃ alkaline phosphatase ≤2.5 × ULN
⁃ creatinine clearance \<25 ml/min We recommend avoiding cisplatin for participants with creatinine clearance \<50 ml/min.
⁃ INR and aPTT £1.5 ULN