Phase III trial of a single early intravesical instillation of pirarubicin in the prevention of bladder recurrence after radical nephroureterectomy for upper tract urothelial carcinoma (JCOG1403, UTUC THP Phase III)

Phase III trial of a single early intravesical instillation of pirarubicin in the prevention of bladder recurrence after radical nephroureterectomy for upper tract urothelial carcinoma (JCOG1403, UTUC THP Phase III) - Phase III trial of a single early intravesical instillation of pirarubicin in the prevention of bladder recurrence after radical nephroureterectomy for upper tract urothelial carcinoma (JCOG1403, UTUC THP Phase III)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000024267

Enrollment

310

Registered

2016-10-03

Start date

2016-10-03

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper tract urothelial carcinoma

Interventions

A: No instillation following radical nephroureterectomy. Postoperative chemotherapy of 2 cycles of gemcitabine at 1000 mg/m2 and cisplatin at 70 mg/m2 every 4 weeks for only high risk patients with pT

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: "First registration 1. Upper tract urothelial carcinoma diagnosed by CT with fulfilling all of the followings: i) primary site is located in the renal pelvis or the ureter, ii) not bilateral. 2. Clinical stage 0a-III(cTa-T3N0M0)diagnosed by CT 3. Aged 20 to 80 years old. 4. ECOG performance status (PS) of 0 or 1. 5. No history of 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 intact kidney is functioning.. 10. Sufficient organ functions. 11. Written informed consent. Second registration 1. Macroscopically proven Ta-3N0M0. 2. No lymph node metastasis if pathological examination during surgery is conducted. 3. No serious intraoperative complication. 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.

Exclusion criteria

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 and male expecting partner's pregnancy. 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.

Design outcomes

Primary

Measure	Time frame
relapse-free survival	—

Secondary

Measure	Time frame
overall survival, intravesical relapse-free survival, adverse events	—

Countries

Japan

Contacts

Public ContactAkihiro Ito/Yoichi Arai

JCOG1403 Coordinating Office Department of Urology, Tohoku University Graduate School of Medicine

JCOG_sir@ml.jcog.jp022-717-7278

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026