Overview

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).

Eligibility

Inclusion Criteria:

1. Histologically proven bladder cancer
2. Urothelial carcinoma
3. Age ≥ 18 years
4. Stage T1b-T4AN0M0
5. TUR-B and PET-CT or CT of thorax/abdomen/pelvis within 8 weeks prior to inclusion
6. Suitable for radiotherapy
7. ECOG/WHO performance status 0-2
8. Written informed consent
9. 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

Exclusion Criteria:

1. Prior pelvic radiation therapy
2. Inability to comply with the protocol
3. Presence of a hip prothesis
4. Grade 2 or greater baseline diarrhea
5. Uncontrolled inflammatory bowel disease (ulcerative colitis or Crohn's disease)