Adjuvant Chemotherapy Following Radical Cystectomy to Treat Locally Advanced Bladder Cancer

Phase 3

• Conditions: Bladder Cancer
• Interventions: Drug: Gemcitabine, Cisplatin

• Registration Number: NCT02074189
• Lead Sponsor: Southwest Hospital, China

Brief Summary

Effect of adjuvant chemotherapy to control tumor progression in patients after cystectomy for locally advanced bladder cancer.

Detailed Description

Effect of adjuvant chemotherapy based on Gemcitabine and Cisplatin to control tumor progression in patients after cystectomy for locally advanced bladder cancer.

Study Timeline

• Status Verified: 2014-02
• Study First Submitted: 2014-02-26
• Study First Submitted QC: 2014-02-27
• Last Update Submitted: 2014-02-27
• Study First Posted: 2014-02-28
• Last Update Posted: 2014-02-28
• Study Start: 2014-03
• Primary Completion: 2019-04
• Study Completion: 2019-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

2. Pathologically confirmed localized invasive bladder cancer following standardize radical cystectomy and pelvic lymphadenectomy.

3. Transitional cell carcinoma of bladder, stage pT3N0M0.Transitional cell carcinoma may be with or without squamous cell carcinoma and/or adenocarcinoma components.

4. Electrocorticography(ECOG) performance status 0-2.

5. Blood routine:Absolute neutrophil count (ANC) ≥ 1500/μL,White blood cell count ≥ 3000/μLPlatelets ≥ 100,000/μL,Hemoglobin ≥ 10.0 g/dL,

6. Total serum bilirubin≤ 1.5 x upper limit of normal (ULN).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).

7. Creatinine clearance rate,Ccr ≥ 60%

8. ECG：no arrhythmias, no myocardial infarction.

   • 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

1. Past history of systemic chemotherapy
2. Serious heart and lung dysfunction.
3. Associated with central or peripheral neuropathy greater than 2 grade.
4. Evidence of distant metastasis beyond the pelvis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adjuvant Chemotherapy	Gemcitabine, Cisplatin	Adjuvant Chemotherapy(Gemcitabine, Cisplatin):Gemcitabine 1000 mg/m2 iv,D1,D8,D15;cisplatin 70 mg/m2 iv,D2.With 4 cycles. Treatment begins between 1-5 weeks after radical operation (within 42 days is recommended)

Primary Outcome Measures

Name	Time	Method
cancer progressive free survival rate	60 months

Secondary Outcome Measures

Name	Time	Method
overall survival	60 months

Trial Locations

Locations (1)

Southwest hospital,China; 🇨🇳 Chongqing, Chongqing, China