Comparison between intravesical BCG therapy and intravesical BCG and MMC therapy for prevention of recurence and treatment of in situ cancer in non-muscle invasive bladder cancer patients with intermediate or high risk disease.

Comparison between intravesical BCG therapy and intravesical BCG and MMC therapy for prevention of recurence and treatment of in situ cancer in non-muscle invasive bladder cancer patients with intermediate or high risk disease. - Comparison between intravesical BCG and BCG+MMC therapy for prevention of recurence and treatment of in situ cancer in intermediate or high risk non-muscle invasive bladder cancer.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000024162

Enrollment

284

Registered

2016-09-27

Start date

2016-10-01

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

Bladder cancer

Interventions

BCG=80mg was performed once a week for 8 times and then once a month for 9 times. BCG=80mg and MMC=40mg were performed once a week for 8 times and then once a month for 9 times.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who match followed all items; 1: Non-muscle invasive bladder cancer with high grade urothelial carcinoma. 2: No metastasis of lymph node and distant organ by any imaging examinations. 3: Radical cystectomy is difficult or no hope of this operation. 4: Eastern Cooperative Oncology Group (ECOG) performance status (PS) was 0-1. 5: Blood examinations fulfill followed data. White blood cells: >3,000/mm3, Neutrophil: >1,500 /mm3, Platelet: >100,000 /mm3, Hemoglobin: >8 g/dl, AST and ALT: <3 times of upper limited value, Total bilirubin: <1.5 mg/dl, Serum creatinine: <2.0 mg/dl, Fating blood sugar: <125 mg/dl

Exclusion criteria

Exclusion criteria: 1: The chance of living over 6 months 2: With active tuberculosis 3: Allergy for BCG or MMC 4: With other maligancy or has plan of treatment for the disease. 5: The doctor judged as improper.

Design outcomes

Primary

Measure	Time frame
Urinary tract recurrence-free survival periods.	—

Countries

Japan

Contacts

Public ContactYasuyoshi Miyata

Nagasaki University Hospital Urology and Renal Transplantation

int.doc.miya@m3.dion.ne.jp095-819-7340

Outcome results

None listed

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