Single-Dose Intravesical Chemotherapy After Diagnostic URS

Launched by DAVID D'ANDREA · Mar 31, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating whether a single dose of chemotherapy given right after a procedure called uretero-renoscopy (URS) can help prevent the return of upper urinary tract cancer (UTUC) in patients. The study will involve 394 participants aged 18 and older who have just been diagnosed with localized UTUC and have no signs of cancer spread to other parts of the body. Participants will be randomly assigned to either receive the chemotherapy or be monitored without treatment.

If you join this study, you can expect to have regular check-ups over five years to monitor your health and any signs of cancer returning. You’ll also have safety visits after the chemotherapy to check for any side effects. Some key eligibility requirements include being at least 18 years old, having a primary diagnosis of localized UTUC, and being willing to follow the treatment plan. It's important to note that certain conditions, like previous bladder cancer or being pregnant, may exclude someone from participating. Overall, this trial aims to find out if this chemotherapy approach can effectively reduce the chances of cancer coming back after the initial diagnosis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Subjects must meet all the following inclusion criteria to participate in this study:
• • Age ≥ 18 years
• • Diagnosis primary localized UTUC
• • Imaging examinations show no distant metastasis
• • Patients who agree to receive SI after URS for UTUC and will undergo the standard treatment, postoperative management, and follow-up in accordance with current guidelines
• Exclusion Criteria:
• • Any concurrent systemic therapy for any cancer
• • Prior bladder cancer within 5 years
• • Prior radical cystectomy
• • Concomitant bladder cancer
• • Bilateral UTUC
• • Pregnancy
• • Patient refused to participate
• • Life expectancy of less than one year
• • Solitary kidney