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Transurethral Resection of Bladder Tumor (TURBT) Combined With Adjuvant Intravenous GC Chemotherapy for high grade T1 bladder cancer

Prospective Cohort Study for Transurethral Resection of Bladder Tumor (TURBT) Combined With Adjuvant Intravenous GC Chemotherapy to Prevent Recurrence and Progression Risks of high grade T1 bladder cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800019355
Enrollment
Unknown
Registered
2018-11-07
Start date
2019-01-01
Completion date
Unknown
Last updated
2018-11-19

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

Conditions

bladder cancer

Interventions

Group 1:GC adjuvant chemotherapy
Group 2:BCG intravesical chemotherapy
Group 3:BCG intravesical chemotherapy

Sponsors

Renji Hospital, School of Medicine, Shanghai Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Aged at least 18 years male and female; (2) Has a performance status of 0 or 1 on the ECOG Performance Scale; (3) Has histological confirmed high grade urothelial carcinoma of bladder; those with mixed histology, including small cell carcinoma, adenocarcinoma, squamous cell carcinoma plasmacytoid carcinoma were excluded; (4) Has clinical stage T1/N0/M0 urothelial carcinoma, clinical stage is based on the pre-study standard of transurethral resection of bladder tumor(TURBT)sample and imaging studies; (5) Has had no prior systemic cytotoxic chemotherapy for urothelial carcinoma; (6) Patients refusal of cystectomy and bilateral pelvic lymphadenectomy; (7) No prior intravesical chemotherapyno prior radiotherapy for bladder cancer; (8) Absolute neutrophil count (ACN) = 1.5 x 10^9/L; Platelets = 100 x 10^9/L; hemoglobin= 9 g/dL, creatinine clearance>60ml/min; serum bilirubin =1.5 X upper limit of normal (ULN), aminotransferase =2.5 X ULN.

Exclusion criteria

Exclusion criteria: (1) Serious or uncontrolled concurrent medical illness (2) Pregnancy (3) Creatinine clearance <60ml/min (4) Inability to comply with study and/or follow-up procedure (5) Known history of human immunodeficiency virus (6) Known active hepatitis B or hepatitis C (7) Immunocompromised (8) Any of the following within 6 months prior to study drug administration: myocardial infarction, severe/ unstable angina, coronary bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack

Design outcomes

Primary

MeasureTime frame
recurence and progression;recurrence;progression;—

Secondary

MeasureTime frame
adverse effect;—

Countries

China

Contacts

Public ContactBo Juanjie

Renji Hospital, School of Medicine, Shanghai Jiaotong University

bojuanjie12@126.com+86 13601839847

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026