Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Combination Chemotherapy and Radiation Therapy With/Without Surgery In Patients With Stage II/III Bladder Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
NRG Oncology
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00055601
First received: March 6, 2003
Last updated: June 30, 2016
Last verified: June 2016
Results First Received: June 30, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Bladder Cancer
Interventions: Drug: cisplatin
Drug: fluorouracil
Drug: paclitaxel
Radiation: radiation therapy
Drug: Gemcitabine
Procedure: Radical cystectomy

  Participant Flow
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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
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Reporting Groups
  Description
Pelvic RT + Paclitaxel + Cisplatin Induction: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
Pelvic RT + Fluorouracil + Cisplatin Induction: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.

Participant Flow:   Overall Study
    Pelvic RT + Paclitaxel + Cisplatin     Pelvic RT + Fluorouracil + Cisplatin  
STARTED     48     49  
COMPLETED     46 [1]   47 [1]
NOT COMPLETED     2     2  
Protocol Violation                 1                 1  
No protocol treatment received                 1                 1  
[1] Subjects with data available for the primary analysis are considered to have completed the study.



  Baseline Characteristics
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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 who started protocol treatment.

Reporting Groups
  Description
Pelvic RT + Paclitaxel + Cisplatin Induction: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
Pelvic RT + Fluorouracil + Cisplatin Induction: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
Total Total of all reporting groups

Baseline Measures
    Pelvic RT + Paclitaxel + Cisplatin     Pelvic RT + Fluorouracil + Cisplatin     Total  
Number of Participants  
[units: participants]
  46     47     93  
Age  
[units: years]
Median (Full Range)
  65  
  (48 to 82)  
  67  
  (44 to 83)  
  66  
  (44 to 83)  
Gender  
[units: participants]
     
Female     8     7     15  
Male     38     40     78  



  Outcome Measures
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1.  Primary:   Treatment Completion Rate   [ Time Frame: From randomization to 11 weeks ]

2.  Secondary:   Complete Response After Induction   [ Time Frame: From randomization to eight weeks ]

3.  Secondary:   Bladder-intact Survival   [ Time Frame: From the date of randomization to the time of cystectomy, death or last follow-up. Patients are followed until death. Analysis occurs at time of primary outcome measure, approximately eight years from study start. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Wendy Seiferheld, M.S.
Organization: NRG Oncology
e-mail: seiferheldw@nrgoncology.org


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

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00055601     History of Changes
Other Study ID Numbers: RTOG 0233
CDR0000258303
ECOG-R0233
NCI-2011-01578 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Study First Received: March 6, 2003
Results First Received: June 30, 2016
Last Updated: June 30, 2016
Health Authority: United States: Food and Drug Administration