Radical CystEctomy or RaDio-chEMotherapy as Preferred Treatment for invasivE blaDder Cancer (NCT07008833) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Radical CystEctomy or RaDio-chEMotherapy as Preferred Treatment for invasivE blaDder Cancer
Brazil336 participantsStarted 2026-06
Plain-language summary
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This is a randomized, non-inferiority study comparing radiochemotherapy to radical cystectomy in patients with muscle-invasive bladder cancer. The primary outcome is the evaluation of the non-inferiority of metastasis-free survival between the two treatments.
The study population includes individuals of both sexes, aged 18 years and older, diagnosed with pure or predominant urothelial carcinoma. Participants will be randomized in a 1:1 ratio, with Arm 1 receiving maximal TURBT followed by neoadjuvant chemotherapy and radiotherapy, and Arm 2 receiving TURBT followed by neoadjuvant chemotherapy with cisplatin, followed by radical cystectomy and bilateral pelvic lymphadenectomy.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Patients ≥ 18 years of age.
✓. Pure or predominant urothelial carcinoma (including other histologic subtypes, with the exception of small cell carcinoma, as a minority component).
✓. Performance status of 0 to 1, according to the Eastern Cooperative Oncology Group (ECOG) criteria.
✓. Life expectancy of ≥ 3 months.
✓. Histologically confirmed T2, T3, or T4a stage bladder cancer (pure or predominant urothelial carcinoma) cN0 or cN1 or cN2 (if lymph nodes within the surgical and radiation fields and size ≤ 2 cm).
✓. Patients who are candidates for neoadjuvant cisplatin and have undergone TURBT (preferably maximal) prior to treatment.
✓. Adequate bladder function (defined as the ability to store and void urine effectively, without symptoms of dysfunction or incontinence).
✓. Neutrophil count ≥ 1500/mm³.
Exclusion criteria
✕
What they're measuring
1
Metastasis-free survival
Timeframe: The time from the start of treatment until detection of 230 metastases in other organs or tissues outside the bladder (including pelvic lymph nodes).or until death from any cause of the patient, estimated to be up to 8 years
. Presence of multiple primary tumors or multiple foci of carcinoma in situ (CIS) (including in the upper tract) that are not candidates for bladder preservation with radiochemotherapy (definition at the discretion of the investigator).
✕. Age \> 80 years.
✕. Pure adenocarcinoma or pure squamous carcinoma or pure small cell or large cell neuroendocrine carcinoma, micropapillary, sarcomatoid or nested.
✕. Metastatic or unresectable disease.
✕. Sensory neuropathy Grade ≥ 2.
✕. Hearing impairment Grade ≥ 2.
✕. Having a known additional malignancy that has progressed or required active treatment in the last 5 years, except superficial bladder cancer and/or carcinoma in situ, basal cell carcinoma of the skin or carcinoma in situ of the cervix.
✕. Clinically significant cardiovascular disease - functional class III-IV according to the New York Heart Association (NYHA) Classification of heart failure.