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Adjuvant Chemotherapy Following Radical Cystectomy to Treat Locally Advanced 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.
 
ClinicalTrials.gov Identifier: NCT02074189
Recruitment Status : Unknown
Verified February 2014 by Zhiwen Chen, Southwest Hospital, China.
Recruitment status was:  Enrolling by invitation
First Posted : February 28, 2014
Last Update Posted : February 28, 2014
Sponsor:
Information provided by (Responsible Party):
Zhiwen Chen, Southwest Hospital, China

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

Condition or disease Intervention/treatment Phase
Bladder Cancer Drug: Gemcitabine, Cisplatin Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adjuvant Chemotherapy Following Radical Cystectomy to Treat Locally Advanced Bladder Cancer
Study Start Date : March 2014
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Active Comparator: Adjuvant Chemotherapy
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)
Drug: 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)
Other Name: GCT

No Intervention: Control
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



Primary Outcome Measures :
  1. cancer progressive free survival rate [ Time Frame: 60 months ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 60 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02074189


Locations
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China, Chongqing
Southwest hospital,China
Chongqing, Chongqing, China, 400030
Sponsors and Collaborators
Southwest Hospital, China
Investigators
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Principal Investigator: Zhiwen Chen, M.D,Ph.D Southwest Hospital, China

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Responsible Party: Zhiwen Chen, M.D,Ph.D, Southwest Hospital, China
ClinicalTrials.gov Identifier: NCT02074189    
Other Study ID Numbers: 2012XLC02-1
2012XLC02 ( Other Grant/Funding Number: 2012XLC02,Third Military Medical University,China )
First Posted: February 28, 2014    Key Record Dates
Last Update Posted: February 28, 2014
Last Verified: February 2014
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Gemcitabine
Cisplatin
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs