Intravesical Instillation Therapy With Bacillus Calmette-Guérin (BCG) and Sequential BCG and Electromotive Mitomycin-C (EMDA-MCC) in Patients With High-risk Non-muscle-invasive Bladder Carcinoma


Condition: Bladder Cancer

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03664869

Sponsor: Turku University Hospital

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: All

Inclusion Criteria:

  • Histologically proven non-muscle-invasive tumour types confined to the urinary bladder
  • Carcinoma in situ with or without a papillary tumour(s)
  • Ta tumour(s) of high-grade
  • Any T1 tumour(s)
  • Written informed consent is required from every eligible patient
  • Second resection performed in case of T1 tumour
  • Adequate physical and mental condition to participate in the study (as judged by treating physician

Exclusion Criteria:

  • Ta low grade tumour(s)
  • Muscle invasive (pT≥2) tumors
  • Urothelial cancer involving the prostatic urethra or upper urinary tract
  • Non-urothelial bladder cancer.
  • Prior BCG failure (If the patient has previously been successfully treated with BCG, and duration from the last instillation is >12 months, participation may be considered, if bladder preserving is chosen)
  • Prior or concurrent immunotherapy
  • Any medication or condition considered as contraindication to BCG or MMC (as judged by the treating physician)
  • Urethral stricture, stone disease, chronic urinary tract infection or any other urological condition that may comprise study participation (as judged by the treating physician)
  • Known allergy to MMC or BCG
  • Age < 18 years
  • Pregnancy or lactating patient
  • Other untreated or unstable malignancy in risk of recurrence/progression (as judged by the treating physician)
  • Cardiac pacemaker
  • Expected survival time less than one year
  • Expected poor compliance

View trial on ClinicalTrials.gov


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