Re-optimization Based Online Adaptive Radiotherapy of Bladder Cancer

  • STATUS
    Recruiting
  • End date
    Mar 29, 2026
  • participants needed
    110
  • sponsor
    Varian, a Siemens Healthineers Company
Updated on 4 October 2022

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).

Details
Condition Muscle-Invasive Bladder Carcinoma
Treatment Varian Ethos Adaptive Radiation Therapy
Clinical Study IdentifierNCT05295992
SponsorVarian, a Siemens Healthineers Company
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
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

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)
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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