Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Cisplatin and Gemcitabine Compared With Observation in Treating Patients Who Have Undergone Surgery for Bladder Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed 18 to 74 Other ITNRC-CU02.00447ST/97 NCI-V02-1715, NCT00054626

Objectives

1. Compare the overall, cause-specific, and disease-free survival of patients with high-risk muscle-invasive transitional cell carcinoma of the bladder treated with adjuvant cisplatin and gemcitabine vs observation after radical cystectomy.
2. Compare the dose intensity and toxicity of two different schedules of cisplatin and gemcitabine in these patients.
3. Compare the quality of life of patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• Histologically confirmed transitional cell carcinoma of the bladder
  • T2 (G3 only) or T3-4 (any G), N0-2 or any T, N1-2, M0
  • No secondary localization



• Radical cystectomy (without residual disease) performed within 10 weeks prior to study entry to include:
  • Men: Cystectomy with removal of prostate and seminal vesicles including 1.5 cm of urethra plus pelvic lymphadenectomy (at least 15 negative lymph nodes are recommended to define as N0)
  • Women: Cystectomy with complete removal of the bladder, uterus, ovaries, and anterior walls of the vagina plus pelvic lymphadenectomy

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• No prior systemic chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• Palliative radiotherapy allowed at relapse for symptomatic bone metastases

Surgery

• See Disease Characteristics

Patient Characteristics:

Age

• 18 to 74

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• WBC at least 3,500/mm³
• Absolute neutrophil count at least 2,000/mm³
• Platelet count at least 100,000/mm³
• Hemoglobin at least 10 g/dL

Hepatic

• Bilirubin less than upper normal limit (ULN)
• Gamma-GT less than ULN
• SGOT and SGPT no greater than 2.5 times ULN
• Alkaline phosphatase no greater than 2.5 times ULN

Renal

• Creatinine no greater than1.25 times ULN
• Creatinine clearance at least 60 mL/min

Cardiovascular

• No congestive heart failure
• No angina pectoris
• No cardiac arrhythmia
• No uncontrolled arterial hypertension
• No history of acute myocardial infarction within the past year

Other

• No other serious concurrent illness

Expected Enrollment

A total of 700 patients (350 per treatment arm) will be accrued for this study within 3 years.

Outcomes

Overall survival at 5 years

Disease-free survival at 5 years
Local disease-free survival at 5 years
Distant disease-free survival at 5 years
Toxicity by WHO system grading after each course
Quality of life after each course and every 6 months during follow-up
Dose intensity at the end of the treatment

Outline

This is a randomized, multicenter study. Patients are stratified according to participating center and disease status (T2 [G3 only] or T3-4 [any G], N0-2 vs any T, N1-2, M0). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients are further randomized to 1 of 2 treatment regimens.
  • Regimen A: Patients receive cisplatin IV on day 2 and gemcitabine IV on days 1, 8, and 15.
  
  
  
  • Regimen B: Patients receive cisplatin IV on day 15 and gemcitabine as in regimen A.

    Treatment in both regimens repeats every 28 days for 4 courses.

  
  
  



• Arm II: Patients undergo observation followed by cisplatin and gemcitabine as in arm I at relapse.

Patients are followed every 3 months for 2 years and then every 6 months thereafter.

Pollera CF, Merendino N, Cianciulli AM, et al.: Preliminary cytogenetic and pharmacogenomic analysis of muscle-invasive transitional-cell carcinoma (TCC) of the bladder in patients (pts) enrolled in the Italian National Research Council (CNR) phase III randomized trial comparing adjuvant cisplatin-gemcitabine (PG) vs observation (OBS) after radical cystectomy. [Abstract] J Clin Oncol 23 (Suppl 16): A-4589, 400s, 2005.

Trial Contact Information

Trial Lead Organizations

Italian National Research Council

Camillo Pollera, MD, Protocol chair		Ph: 39-761-339-042

Registry Information
Official Title		Phase III Study Of Adjuvant Cisplatin-Gemcitabine Vs. Observation After Radical Cystectomy In High-Risk Bladder Cancer
Trial Start Date		2001-09-01
Trial Completion Date		2008-06-30 (estimated)
Registered in ClinicalTrials.gov		NCT00054626
Date Submitted to PDQ		2002-10-09
Information Last Verified		2008-11-30

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