Radiotherapy for BCG-Unresponsive Bladder CIS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label, single-arm Phase 2 trial exploring the use of radiotherapy for patients with high-risk non-muscle-invasive bladder cancer who did not respond to BCG and are not candidates for radical cystectomy. Eligible participants include adults with CIS with or without high-grade Ta or T1 disease, good performance status, and adequate organ function. Patients receive a defined course of radiation therapy and are followed to assess responses and safety. The goal is to determine whether radiotherapy can provide disease control and meaningful benefit in this challenging setting.

Why it matters

Who can join: the full rules

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

Where it's running

• Institut Jules Bordet
  Anderlecht, Brussels Capital, Belgium Recruiting
• Cliniques Universitaires Saint-Luc
  Brussels, Belgium Recruiting
• Ziekenhuis aan de Stroom
  Wilrijk, Belgium Recruiting

Study contacts

• Study coordinator: Eortc Hq
• Email: eortc@eortc.org
• Phone: +32 2 774611

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Sequential Gemcitabine Plus Docetaxel vs Gemcitabine Plus Mitomycin C for BCG-Unresponsive NMIBC

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• Is ongoing systemic immunotherapy needed after achieving tumor-free status in very-high-risk NMIBC?

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• Comparing CT and MRI with VI-RADS for Bladder Cancer Staging

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• Cretostimogene for BCG‑unresponsive high‑grade non‑muscle‑invasive bladder cancer

  This treatment will test cretostimogene plus n‑dodecyl‑β‑D‑maltoside in adults whose high‑grade non‑muscle‑invasive bladder cancer did not respond to BCG (carcinoma in situ with or without Ta/T1 tumors).

  Recruiting at 14 sites Phase 2 Lepu Biopharma Co., Ltd. · Beijing, Beijing Municipality and 13 other locations · NCT07283835

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.