Upper urothelial carcinoma (renal pelvis and ureter) Ureteral cancer, renal pelvis cancer
Conditions
Interventions
Group A: No continuous bladder lavage
Group B: Group that performs continuous bladder lavage
Sponsors
Inoue Takahiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Disease name Upper urothelial carcinoma (cancer of the renal pelvis and ureter) Stage 0a-3 (cTa-T3), cN0, cM0 2) Age. 18 to 80 years old 3) Performance Status (ECOG). 0 to 1 4) Patients with written consent to participate in the study
Exclusion criteria
Exclusion criteria: 1) Those who have a history of treatment for bladder cancer prior to radical nephrectomy for UTUC 2) Those who have a history of treatment for UTUC in the past 3) Those who have metastatic lesions (lymph nodes, other organs, etc.) at the time of diagnosis 4) Those who have a history of radiation therapy 5) Those who are pregnant or may be pregnant, or are breastfeeding 6) Those who are judged by the principal investigator or sub-investigator to be unsuitable as research subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be the duration of recurrence-free period in the bladder during the 108-week observation period from the date of surgery. The bladder recurrence-free period is defined as the period from the date of surgery to the date of confirmation of recurrence by cystoscopy. In cases with no follow-up, the period is terminated on the last day of confirmed recurrence-free period before the loss of follow-up. However, for cases without 108-week follow-up, data on the presence or absence of recurrence at the last observation will be used. Deaths without intracisternal recurrence within 108 weeks shall be treated as no intracisternal recurrence. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints will be the bladder recurrence-free rate, overall survival, recurrence-free survival, adverse events associated with continuous bladder lavage, and factors related to bladder recurrence during the 108-week observation period from the date of surgery. | — |
Contacts
Public ContactShunsuke Owa
Mie University Hospital
Outcome results
None listed