Clinical trial · Interventional
Adjuvant Intraarterial Chemotherapy Following Surgery to Treat Locally Advanced Bladder Cancer
Adjuvant Intraarterial Chemotherapy Following Surgery in Treating Patients with Locally Advanced Bladder Cancer
NCT01627197CI-TRIAL-00082218completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Effect of adjuvant intra-arterial chemotherapy to control tumor progression in patients cystectomized for locally advanced bladder cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Surgery of percutaneous catheter system | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Intraaterial chemotherapy
- description
- This is an open-label, prospective, multicenter, randomized, controlled phase 3 two-arm study.Patients with locally advanced TCC of the bladder are randomized to 1 of 2 treatment arms Arm 1 (treatment):'Surgery of percutaneous catheter system for arterial chemotherapy is done in the Department of Invasive Technology. All medications were administered using percutaneous catheter system via a modified Seldinger technique.Gemcitabine 800 mg/m2 intra-arterial,cisplatin 25 mg/m2 intra-arterial once a week for 3 weeks followed by 1-week rest period. Maximum of 3 cycles. Treatment begins between 1-5 weeks after radical operation (within 40 days is recommended).
- interventionNames
- Procedure: Surgery of percutaneous catheter system
- type
- NO_INTERVENTION
- label
- Watchful waiting
- description
- Arm 2 (control): No immediate post-surgery treatment. Patients undergo observation followed by cisplatin and gemcitabine as in arm I at local relapse, or receive intravenously chemotherapy with cisplatin and gemcitabine at multiple metastases
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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 components. * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.