Status:
NOT_YET_RECRUITING
Radiotherapy for BCG-unresponsive Non-muscle-invasive Carcinoma in Situ (CIS) Bladder Cancer: an Open-label, Single-arm, Multicentre, Phase 2 Study
Lead Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Conditions:
Non-Muscle Invasive Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Standard treatment for patients with high-risk NMIBC (high-grade Ta, CIS, or any T1) consists of intravesical Bacillus Calmette-Guerin (BCG) immunotherapy. However, BCG, even administered optimally, d...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Evidence of muscle invasive or metastatic urothelial carcinoma
- Evidence of upper urinary tract carcinoma
- Poor bladder function (IPSS \>16)
- Hydronephrosis due to tumour in the presence of T1 disease
- Patients on current systemic therapy for bladder cancer
- Patients who have received pelvic external beam radiotherapy within the previous 5 years
- Any known contraindications or allergies to the use of local standard of care radiosensitiser, if applicable
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 18 2031
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06990061
Start Date
December 1 2025
End Date
September 18 2031
Last Update
May 25 2025
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