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JCOG1403: Phase III trial of a single early intravesical instillation of pirarubicin in the prevention of bladder recurrence after nephroureterectomy for upper tract urothelial carcinoma

Phase 3
Conditions
pper tract urothelial carcinoma
Registration Number
JPRN-jRCTs031180121
Lead Sponsor
ITO Akihiro
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
310
Inclusion Criteria

First registration
1. Upper tract urothelial carcinoma located primarily in the renal pelvis or the ureter with fulfilling all of the followings:
i) clinically diagnosed with enhanced CT imaging or with urographic imagingor ureteroscopy in the difficult case of diagnosing with enhanced CT imaging
ii) without requiring histological diagnosis
iii) not bilateral
iv) solitary or multiple tumors
2. Clinical stage 0a-III(cTa-T3N0M0)diagnosed by CTimaging.
3. Aged 20 to 80 years old.
4. ECOG performance status (PS) of 0 or 1.
5. No prior treatment for upper tract urothelial carcinoma.
6. No bladder cancer diagnosed by cystoscopy.
7. No history of bladder cancer.
8. No history of irradiation including the bladder.
9. The kidney located on the opposite side of the upper tract urothelial carcinoma is functioning..
10. Sufficient organ functions.
11. Written informed consent.

Second registration
1. Macroscopically proven cTa-3N0M0 in the intraoperative findings or in the extirpated specimens
2. No lymph node metastasis if pathological examination during surgery is conducted.
3. No serious intraoperative complications those interfere the protocol.
4. No leak after bladder wall resection of the ureteral orifice site.
5. Resection margin of the ureter is macroscopically negative.
6. Within 56 days from the date of cystoscopy.
7. Within 91 days from the date of CT.
8. Urine cytology is performed once if it is positive, or three times if it is negative or false positive

Exclusion Criteria

First registration (no exclusion criteria at second registration)
1. Synchronous or metachronous (within 5 years) malignancies.
2. Infectious disease requiring systemic treatment.
3. Pyrexia of 38 degrees centigrade or higher.
4. Female during pregnancy, within 28 days of postparturition, or during lactation
5. Severe psychological disorder.
6. Receiving continuous systemic corticosteroid or immunosuppressant treatment.
7. History of abnormal cardiac function or having received the limit dose of medications with cardiac toxicity such as anthracyclines.
8. Positive HIV antibody.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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