Phase III clinical trial in determining treatment strategy for patients with High grade T1 bladder cancer who have pT0 histology on the second TUR (JCOG1019, BC pT0 PhaseIII)

Phase III clinical trial in determining treatment strategy for patients with High grade T1 bladder cancer who have pT0 histology on the second TUR (JCOG1019, BC pT0 PhaseIII) - Phase III clinical trial in determining treatment strategy for patients with High grade T1 bladder cancer who have pT0 histology on the second TUR (JCOG1019, BC pT0 PhaseIII)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006390

Enrollment

260

Registered

2011-09-22

Start date

2011-09-22

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

High grade T1 bladder cancer

Interventions

A: BCG intravesical therapy (q1w, 8 courses) B: watchful

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: "First registration 1. Bladder tumor endoscopically resected completely by TURBT with fulfilling all of the followings histologically: i) high grade T1, ii) containing component of urothelial carcinoma, iii) containing component of tunica propria. 2. Aged 20 to 85 years old. 3. Within 56 days from the date of TURBT. 4. ECOG performance status (PS) of 0 or 1. 5. No history of administration of Cyclophosphamide and Methotrexate. 6. No history of irradiation for pelvic lesion. 7. No history of BCG intravesical therapy. 8. Neither history of bladder cancer except Tis, Ta bladder cancer nor history of upper urinary tract cancer(ureteral cancer and/or renal pelvic cancer). 9. Sufficient organ functions. 10. Not strongly positive for tuberculin reaction. 11. Written informed consent. Second registration 1. Histologically proven T0 by 2nd TUR. 2. Negative or suspected positive in 2 consecutive urine cytology. 3. Within 28 days from the date of 2nd TUR. 4. Sufficient bone marrow functions. 5. No regional lymph node or distant metastasis examined by abdominopelvic CT or MRI.

Exclusion criteria

Exclusion criteria: First registration (no exclusion criteria at second registration) 1. Simultaneous or metachronous (within 5 years) double cancers. 2. Infectious disease (including tuberculosis) to be treated. 3. Body temperature of 38C or higher. 4. Positive anti-HIV antibody. 5. Women during pregnancy or breast-feeding. 6. Psychiatric diseases. 7. Systemic and continuous steroids medication. 8. History of severe brain ischemia or myocardial infarction within 6 months. 9. History of systemic anaphlactoid reaction for BCG.

Design outcomes

Primary

Measure	Time frame
relapse-free survival (except Tis or Ta intravesical recurrence)	—

Secondary

Measure	Time frame
overall survival, metastasis-free survival with bladder preserved, annual intravesical relapse-free survival rate, annual proportion of T2 or deeper relapse-free survival, adverse events, serious adverse events	—

Countries

Japan

Contacts

Public ContactHiroshi Kitamura

JCOG1019 Coordinating Office Department of Urology, Graduate School of Medicine and Pharmaceutical Sciences. University of Toyama

JCOG_sir@ml.jcog.jp076-434-7372

Outcome results

None listed

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