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S0337, Gemcitabine After Surgery in Treating Patients With Newly Diagnosed or Recurrent Bladder Cancer

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ClinicalTrials.gov Identifier: NCT00445601
Recruitment Status : Completed
First Posted : March 9, 2007
Results First Posted : April 24, 2018
Last Update Posted : April 24, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Bladder Cancer
Interventions: Drug: gemcitabine hydrochloride
Other: placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm I

Patients receive intravesical gemcitabine hydrochloride over 1 hour post-TURBT.

gemcitabine hydrochloride: Given intravesically

Arm II

Patients receive intravesical placebo over 1 hour post-TURBT.

placebo: Given intravesically


Participant Flow:   Overall Study
    Arm I   Arm II
STARTED [1]   201   205 
Received TURBT   190   193 
COMPLETED [2]   168   177 
NOT COMPLETED   33   28 
Withdrawal by Subject                11                11 
TURBT Complication                12                8 
Incorrect Disease Status                6                6 
Drug Delivery Issue                2                2 
Adverse Event                2                0 
Death prior to TURBT                0                1 
[1] Randomized to Treatment Arm
[2] Received Drug Instillation



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All eligible patients

Reporting Groups
  Description
Arm I

Patients receive intravesical gemcitabine hydrochloride over 1 hour post-TURBT.

gemcitabine hydrochloride: Given intravesically

Arm II

Patients receive intravesical placebo over 1 hour post-TURBT.

placebo: Given intravesically

Total Total of all reporting groups

Baseline Measures
   Arm I   Arm II   Total 
Overall Participants Analyzed 
[Units: Participants]
 201   205   406 
Age 
[Units: Years]
Median (Full Range)
 66 
 (38 to 97) 
 66 
 (35 to 93) 
 66 
 (35 to 97) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      38  18.9%      24  11.7%      62  15.3% 
Male      163  81.1%      181  88.3%      344  84.7% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Race       
White      186  92.5%      185  90.2%      371  91.4% 
Black      6   3.0%      9   4.4%      15   3.7% 
Asian      4   2.0%      5   2.4%      9   2.2% 
Native American      0   0.0%      2   1.0%      2   0.5% 
Unknown      5   2.5%      4   2.0%      9   2.2% 
Occurence status 
[Units: Participants]
Count of Participants
     
First Occurence      128  63.7%      128  62.4%      256  63.1% 
Recurrent      66  32.8%      77  37.6%      143  35.2% 
Unknown      7   3.5%      0   0.0%      7   1.7% 
Number of tumors 
[Units: Participants]
Count of Participants
     
    135  67.2%      140  68.3%      275  67.7% 
>= 2      66  32.8%      65  31.7%      131  32.3% 
Prior intravesical therapy 
[Units: Participants]
Count of Participants
     
Yes      39  19.4%      39  19.0%      78  19.2% 
No      162  80.6%      166  81.0%      328  80.8% 
Zubrod Performance Status [1] 
[Units: Participants]
Count of Participants
     
    157  78.1%      165  80.5%      322  79.3% 
    44  21.9%      40  19.5%      84  20.7% 
[1]

Zubrod Performance Status Scale:

0. Fully active, able to carry on all pre-disease performance without restriction.

  1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light housework, office work.
  2. Ambulatory and capable of self-care but unable to carry out any work activities; up and about more than 50% of waking hours.
  3. Capable of limited self-care, confined to bed or chair more than 50% of waking hours.
  4. Completely disabled; cannot carry on any self-care; totally confined to bed or chair.
Smoking history 
[Units: Participants]
Count of Participants
     
Current      49  24.4%      54  26.3%      103  25.4% 
Prior      98  48.8%      101  49.3%      199  49.0% 
Never      54  26.9%      46  22.4%      100  24.6% 
Unknown      0   0.0%      4   2.0%      4   1.0% 


  Outcome Measures

1.  Primary:   Disease Recurrence Rate   [ Time Frame: Up to 2 Years ]

2.  Secondary:   Rate of Progression to Muscle Invasive Disease at 4 Years   [ Time Frame: 4 years ]

3.  Secondary:   Compare Qualitative and Quantitative Toxicities Between the Treatment Arms   [ Time Frame: Up to 4 years after Transurethral Resection of Bladder Tumor (TURBT) ]

4.  Secondary:   Rate of Disease Worsening Over 2 Years   [ Time Frame: Up to 2 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Catherine Tangen, Genitourinary Committee Statistician
Organization: SWOG Statistics and Data Management Center
phone: 206-667-2933
e-mail: ctangen@fredhutch.org


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00445601     History of Changes
Other Study ID Numbers: CDR0000534235
S0337 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: March 7, 2007
First Posted: March 9, 2007
Results First Submitted: December 21, 2017
Results First Posted: April 24, 2018
Last Update Posted: April 24, 2018