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.
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.
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.
Parallel
Radiochemotherapy
Procedure/SurgeryMaximum 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.
Radical cystectomy
Procedure/SurgeryTURBT 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.
Metastasis-free survival
The primary outcome is the assessment of the non-inferiority of metastasis-free survival between radiochemotherapy and radical cystectomy.
Overall survival
Overall survival of radiochemotherapy versus radical cystectomy.
Muscle-invasive bladder cancer-free survival
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
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).
Click on the lead sponsor to view all of their trials.
Brazilian Clinical Research Institute
Lead sponsor
Ministry of Science and Technology, Brazil
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
