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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00054626
Recruitment Status : Unknown
Verified November 2008 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : February 6, 2003
Last Update Posted : December 18, 2013
Information provided by:
National Cancer Institute (NCI)

February 5, 2003
February 6, 2003
December 18, 2013
September 2001
June 2008   (Final data collection date for primary outcome measure)
Overall survival at 5 years
Not Provided
Complete list of historical versions of study NCT00054626 on Archive Site
  • 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
Not Provided
Not Provided
Not Provided
Cisplatin and Gemcitabine Compared With Observation in Treating Patients Who Have Undergone Surgery for Bladder Cancer
Phase III Study Of Adjuvant Cisplatin-Gemcitabine Vs. Observation After Radical Cystectomy In High-Risk Bladder Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. It is not yet known if combination chemotherapy is effective in preventing relapse in patients who have undergone radical cystectomy for bladder cancer.

PURPOSE: Phase III trial to compare the effectiveness of cisplatin combined with gemcitabine with that of observation in treating patients with bladder cancer who have undergone surgery to remove the bladder.


  • 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.
  • Compare the dose intensity and toxicity of two different schedules of cisplatin and gemcitabine in these patients.
  • Compare the quality of life of patients treated with these regimens.

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.

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

Phase 3
Allocation: Randomized
Primary Purpose: Treatment
Bladder Cancer
  • Drug: cisplatin
  • Drug: gemcitabine hydrochloride
  • Procedure: adjuvant therapy
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Not Provided
Not Provided
June 2008   (Final data collection date for primary outcome measure)


  • 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



  • 18 to 74

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified


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


  • 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


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


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


  • No other serious concurrent illness


Biologic therapy

  • Not specified


  • No prior systemic chemotherapy

Endocrine therapy

  • Not specified


  • Palliative radiotherapy allowed at relapse for symptomatic bone metastases


  • See Disease Characteristics
Sexes Eligible for Study: All
18 Years to 74 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
Not Provided
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Not Provided
Study Chair: Camillo F. Pollera, MD Presidio Ospedaliero Belcolle
National Cancer Institute (NCI)
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP