1-Year Recurrence After En Bloc Resection for Large Bladder Tumors

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

Adults with suspected non-muscle invasive bladder cancer and tumors larger than 2.5 cm will be randomized to receive either en bloc resection or transurethral resection of the bladder tumor. The study will compare pathological and oncological outcomes, including recurrence, between the two surgical approaches. Eligible participants will have ECOG performance status 0-2 and no prior systemic cancer therapies. Key exclusions include multifocal disease, metastasis, prior BCG-unresponsive cancer, and contraindications to endoscopic surgery. The trial is conducted at multiple centers with lead sponsorship by a named investigator, and participation requires informed consent.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients aged ≥18 years with
* Bladder tumor \>2.5cm measured on US\\CT\\MRI (suspected non-muscle invasive bladder cancer).
* Performance status (ECOG) ≤2.
* Signed informed consent form to participate in the study

Exclusion Criteria:

* Multifocal tumors (≥4 lesions).
* Prior history of BCG unresponsive bladder cancer.
* Prior systemic chemotherapy or immunotherapy for any malignancy.
* UTUC.
* Evidence of metastatic disease.
* Contraindications for endoscopic surgery for bladder tumor.
* Benign bladder tumor on postoperative pathology.

Where it's running

• Rabin Medical Center
  Petah Tikva, Israel Recruiting

Study contacts

• Study coordinator: Avishay Reuven Shem Tov Dlugy, MD
• Email: avishaishe@clalit.org.il
• Phone: +972546648489

Similar studies

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

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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.