Adjuvant Chemotherapy Following Radical Cystectomy to Treat Locally Advanced Bladder Cancer

Army Medical University

Status and phase: Unknown; Phase 3

Conditions: Bladder Cancer

Treatments: Drug: Gemcitabine, Cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT02074189

2012XLC02-1

2012XLC02 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full description

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

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Adjuvant Chemotherapy

Active Comparator group

Description:

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)

Treatment:

Drug: Gemcitabine, Cisplatin

Control

No Intervention group

Description:

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