Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2025-12-24 @ 1:04 PM
NCT ID:
NCT06990061
Eligibility Criteria:
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.
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06990061
Study Brief:
Protocol Section:
NCT06990061