Compares two treatments for muscle-invasive bladder cancer
Compares radiochemotherapy with surgical bladder removal in adults with muscle-invasive bladder cancer.
Plain-language title generated from the registry record
Registry title: Radical CystEctomy or RaDio-chEMotherapy as Preferred Treatment for invasivE blaDder Cancer
Key facts
- Where
- São Paulo, BrazilSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07008833, who can take part
Where in Brazil
- Brazilian Clinical Research InstituteSão Paulo, BrazilNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Brazilian Clinical Research Institute
- Trial code
- NCT07008833
- Record updated
- 29 October 2026
- Original description
Your text is mostly clear and well-structured. Here's a slightly polished version for improved clarity and flow:Read full original descriptionShow less
Randomized, Non-inferiority Study Comparing Radiochemotherapy Versus Radical Cystectomy in Patients With Muscle-invasive Bladder Cancer
Your text is mostly clear and well-structured. Here's a slightly polished version for improved clarity and flow:
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.
Inclusion: 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; Platelet count ≥ 100,000/mm³; Hemoglobin count > 10 g/dL; Glomerular filtration rate greater than 40 mL/min; Serum bilirubin < 1.5 times the upper limit of the normal reference range and SGOT and SGPT < 1.5 times the upper limit of the normal reference range; Absence of comorbidities that contraindicate treatment; Capable of giving signed and dated informed consent prior to any mandatory study-specific procedures, sampling, and analyses, which includes compliance with the requirements and restrictions listed in the informed consent form and study protocol; For inclusion in i) optional exploratory genetic research and ii) optional biomarker research, patients must meet the following criteria:; Provide informed consent for genetic research prior to sample collection; Provide informed consent for biomarker research prior to sample collection; If a patient declines to participate in optional biomarker research, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study.
Exclusion: Patients receiving any prior systemic chemotherapy in the last 5 years for other tumors and at any time for muscle-invasive bladder cancer; Patients who have received prior systemic immunotherapy at any time, either in the setting of non-muscle-invasive bladder cancer or in treatment for other types of cancer; Prior pelvic radiotherapy; Prior Randomization to the present study; Metastatic or unresectable disease; 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; Patients considered to be at high medical risk due to severe and uncontrolled disease, active or non-malignant systemic disease, and severe or potentially severe infection that may affect response to treatment or increase the risk of adverse events; Inflammatory bowel disease; Patients with known active hepatitis (i.e., hepatitis B or C); Age > 80 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); Pure adenocarcinoma or pure squamous carcinoma or pure small cell or large cell neuroendocrine carcinoma, micropapillary, sarcomatoid or nested; Sensory neuropathy Grade ≥ 2; Immunocompromised patients; Patients, male or female, who do not agree to use an effective method of contraception throughout treatment and until 6 months after discontinuation of treatment; Women who are pregnant or currently breastfeeding. 18. The investigator's judgment that the patient should not participate in the study if the patient is unlikely to comply with the procedures, restrictions, and requirements.