Radiotherapy for BCG-unresponsive Non-muscle-invasive Carcinoma in Situ (CIS) Bladder Cancer: an Open-label, Single-arm, Multicentre, Phase 2 Study

Inclusion Criteria

• •Histologically confirmed, BCG-unresponsive, high-risk non-muscle-invasive bladder cancer (according to EAU guidelines \[2\] (see table 1)) °of predominantly (\>50%) urothelial histology who were ineligible for or declined to undergo radical cystectomy.
• •* Patients with carcinoma in situ with or without high-grade Ta or T1 are allowed if patients with concomitant Ta and T1 tumors have undergone complete TURBT, defined as per standard of care as a visually complete resection. A second TURBT is recommended but not required for patients with T1 tumor.
• •* The most recent cystoscopy or TURBT must have been done within 12 weeks before study enrolment.
• •* Eastern Cooperative Oncology Group performance status of 0-2
• •* Adequate organ function (at minimum WBC \> 4.0 × 109/L; platelets \> 100 × 109/L; GFR \> 25mL/min)
• •* 18 years or older
• •* Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 72 hrs prior to the first day of radiation.
• •* Patients of childbearing / reproductive potential should use adequate birth control measures during the study treatment period and for at least 4 weeks after the last day of radiation. A highly effective method of birth control is defined as a method which results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly. Such methods include:
• •* Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
• •* Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
• •* Intrauterine device (IUD)
• •* Intrauterine hormone-releasing system (IUS)
• •* Bilateral tubal occlusion
• •* Vasectomized partner
• •* Sexual abstinence (the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient)
• •* Before patient 's enrolment, written informed consent must be given according to ICH/GCP, and national/local regulations.