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Clinical Trials in Denmark / NCT05295992
Active, not recruiting Not applicable

Conventionally Fractionated Adaptive Radiation Therapy of Bladder Cancer an Individualized Approach

NCT05295992 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2022-03-15
Last updated
2026-03-06

Condition(s) studied

Muscle-Invasive Bladder Carcinoma

Investigational drug(s) / intervention(s)

Varian Ethos Adaptive Radiation Therapy

Varian Ethos Adaptive Radiation Therapy: Daily adaptive external beam radiation therapy delivered on Varian Ethos treatment system.

Study 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 acute gastrointestinal toxicity compared with the historically reported rate for non-adaptive intensity modulated radiation therapy (IMRT).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Herlev and Gentofte Hospital Herlev Denmark

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05295992 on ClinicalTrials.gov ↗ ← All trials in Denmark