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Adjuvant Intraarterial Chemotherapy Following Surgery in Treating Patients With Locally Advanced Bladder Cancer

Phase 3
18 Years
Open (Enrolling by invite only)
Bladder Cancer

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Trial Information

Adjuvant Intraarterial Chemotherapy Following Surgery in Treating Patients With Locally Advanced Bladder Cancer

Inclusion Criteria:

- Pathologically confirmed localized invasive bladder cancer following standardize
radical cystectomy.

- Transitional cell carcinoma of bladder, stage pT3-4,N1-3,M0.Transitional cell
carcinoma may be with or without squamous cell carcinoma and/or adenocarcinoma

- Male or female, 18 years of age or older, estimated life expectancy ≥ 6 months.

- ECOG performance status 0 or 1.

- Serum aspartate transaminase (AST; serum glutamic oxaloacetic transaminase[SGOT]) and
serum alanine transaminase (ALT; serum glutamic pyruvic transaminase [SGPT]) ≤ 2.5 x
upper limit of normal (ULN).Total serum bilirubin≤ 1.5 x upper limit of normal (ULN).

- Absolute neutrophil count (ANC) ≥ 1500/μL

- Platelets ≥ 75,000/μL

- Hemoglobin ≥ 8.0 g/dL

- White blood cell count ≥ 3500/μL

- Creatinine clearance rate,Ccr ≥ 40ml/min

- Cardiac function level 0~2.

- Signed and dated informed consent document indicating that the patient (or legally
acceptable representative) has been informed of all pertinent aspects of the trial
prior to enrollment.

- Willingness and ability to comply with scheduled visits, treatment plans, laboratory
tests,and other study procedures.

Exclusion Criteria:

- Bladder cancer without any transitional cell carcinoma component,such as
adenocarcinoma,squamous cell carcinoma,small cell carcinoma

- Evidence of distant metastasis beyond the pelvis.

- No definitely pathological stage,such as no pathologic examination of perivesical
fat,unable to differentiate pT2 and pT3,not performing lymph node dissection or
regional lymph nodes cannot be assessed as the dissected lymph node number is less
than ten.

- Prior neoadjuvant chemotherapy (systemic or intra-arterial) three months
preoperatively, not including intra-vesical infusion chemotherapy.

- Prior pelvic radiation therapy dosage ≥ 30Gy six months preoperatively.

- Serious liver and kidney dysfunction.

- Accompanied with other serious diseases.

- Severe/unstable angina, arrhythmia,symptomatic heart failure, hypertension that
cannot be controlled by medications and 6 months for myocardial infarction.

- Non-compliance of regular follow-up due to psychological, social, family and
geographical and other reasons.

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

cancer progressive free survival rate

Outcome Time Frame:

60 months

Safety Issue:


Principal Investigator

Fang-Jian Zhou, M.D Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sun Yat-sen University


China: Food and Drug Administration

Study ID:




Start Date:

June 2012

Completion Date:

December 2021

Related Keywords:

  • Bladder Cancer
  • Effects of Chemotherapy
  • Urinary Bladder Neoplasms