Active — Not RecruitingNot Applicable

Conventionally Fractionated Adaptive Radiation Therapy of Bladder Cancer an Individualized Approach

Denmark110 participantsStarted 2022-03-15

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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)

What they're measuring

Early Rate CTCAE GI Toxicity

Timeframe: Start of radiotherapy to 3 months after end of radiotherapy

Trial details

NCT IDNCT05295992

SponsorVarian, a Siemens Healthineers Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12

View on ClinicalTrials.gov More Muscle-Invasive Bladder Carcinoma trials