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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
336
Maximum TURBT will be followed by neoadjuvant chemotherapy with cisplatin at a dose of 35 mg/m². After 2-6 weeks of neoadjuvant chemotherapy, patients will receive radiotherapy for 4 weeks, with concomitant cisplatin at a dose of 40 mg/m² weekly.
TURBT will be followed by neoadjuvant chemotherapy with cisplatin at a dose of 35 mg/m², followed by radical cystectomy, bilateral pelvic lymphadenectomy, and reconstruction with either a Bricker procedure or a neobladder.
Brazilian Clinical Research Institute
São Paulo, São Paulo, Brazil
Metastasis-free survival
The primary outcome is the assessment of the non-inferiority of metastasis-free survival between radiochemotherapy and radical cystectomy.
Time frame: 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
Overall survival
Overall survival of radiochemotherapy versus radical cystectomy.
Time frame: The duration from treatment initiation until the study accrues 230 patients with a primary event, or 6 years of follow-up
Muscle-invasive bladder cancer-free survival
Time frame: The duration from treatment initiation until the study accrues 230 patients with a primary event, or 6 years of follow-up
Incidence of tumors in the upper tract (in both arms)
The proportion of patients who develop new tumors in the upper urinary tract in 6 years
Time frame: The duration from treatment initiation until the study accrues 230 patients with a primary event, or 6 years of follow-up
Adverse Events assessment
All adverse events will be collected and classified according to CTCAE v5.0. The protocol defines the following adverse events of special interest for the Radical Cystectomy group: surgical (infections, bleeding, organ injury, thromboembolism), postoperative (fistula, stricture, hernia, delayed healing), and long-term complications (renal insufficiency, GI disorders, sexual dysfunction, body image issues). And Chemoradiotherapy group: acute effects (cystitis, proctitis, enteritis, nausea, vomiting) and severe toxicities (hematologic toxicity, grade 3-4 diarrhea, skin toxicity).
Time frame: The duration from treatment initiation until the study accrues 230 patients with a primary event, or 6 years of follow-up
Quality of Life assessment
Assessment of the perception of patients with bladder cancer about their general well-being, including symptoms of the disease, impact of treatment, psychological and emotional aspects, and the ability to perform physical and social activities, measured through the EORTC QLQ-BLM30 questionnaire.
Time frame: The duration from treatment initiation until the study accrues 230 patients with a primary event, or 6 years of follow-up
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