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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2008 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: February 5, 2003
Last updated: December 17, 2013
Last verified: November 2008

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.

Condition Intervention Phase
Bladder Cancer
Drug: cisplatin
Drug: gemcitabine hydrochloride
Procedure: adjuvant therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Phase III Study Of Adjuvant Cisplatin-Gemcitabine Vs. Observation After Radical Cystectomy In High-Risk Bladder Cancer

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival at 5 years

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 700
Study Start Date: September 2001
Estimated Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00054626

  Show 151 Study Locations
Sponsors and Collaborators
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Study Chair: Camillo F. Pollera, MD Presidio Ospedaliero Belcolle
  More Information

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. Identifier: NCT00054626     History of Changes
Other Study ID Numbers: CDR0000258426
Study First Received: February 5, 2003
Last Updated: December 17, 2013

Keywords provided by National Cancer Institute (NCI):
stage II bladder cancer
stage III bladder cancer
stage IV bladder cancer
transitional cell carcinoma of the bladder

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on April 21, 2017