Status:
RECRUITING
Conventionally Fractionated Adaptive Radiation Therapy of Bladder Cancer an Individualized Approach
Lead Sponsor:
Varian, a Siemens Healthineers Company
Collaborating Sponsors:
Herlev Hospital
Rigshospitalet, Denmark
Conditions:
Muscle-Invasive Bladder Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 a...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Prior pelvic radiation therapy
- Inability to comply with the protocol
- Presence of a hip prothesis
- Grade 2 or greater baseline diarrhea
- Uncontrolled inflammatory bowel disease (ulcerative colitis or Crohn's disease)
Key Trial Info
Start Date :
March 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT05295992
Start Date
March 15 2022
End Date
March 1 2026
Last Update
March 14 2023
Active Locations (1)
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1
Herlev and Gentofte Hospital
Herlev, Denmark, DK-2730