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Trial record 10 of 26 for:    upper tract urothelial

Clinical Trial Of Neoadjuvant Chemotherapy (NAC)In Upper Tract Urothelial Carcinoma (UTUC)

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: NCT01663285
Recruitment Status : Terminated (Low study participant enrollment.)
First Posted : August 13, 2012
Results First Posted : September 18, 2014
Last Update Posted : December 3, 2015
Sponsor:
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Urothelial Cancer
Bladder Cancer
Intervention Drug: Neoadjuvant Cisplatin and Gemcitabine
Enrollment 1
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Neoadjuvant Gemcitabine and Cisplatin
Hide Arm/Group Description Neoadjuvant Cisplatin and Gemcitabine: Cisplatin 70 mg/m2 through IV for 60 minutes on day 1 of each cycle. Gemcitabine 1,000 mg/m2 IV for 30 minutes on days 1 and 8 during each cycle. Treatment is expected to continue for up to 4 cycles. Chemotherapy will be followed by radical nephroureterectomy within 6 weeks (+/- 2 weeks) from the last date of chemotherapy.
Period Title: Overall Study
Started 1
Completed 1
Not Completed 0
Arm/Group Title Neoadjuvant Gemcitabine and Cisplatin
Hide Arm/Group Description Neoadjuvant Cisplatin and Gemcitabine: Cisplatin 70 mg/m2 through IV for 60 minutes on day 1 of each cycle. Gemcitabine 1,000 mg/m2 IV for 30 minutes on days 1 and 8 during each cycle. Treatment is expected to continue for up to 4 cycles. Chemotherapy will be followed by radical nephroureterectomy within 6 weeks (+/- 2 weeks) from the last date of chemotherapy.
Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 1 participants
46
(46 to 46)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
0
   0.0%
Male
1
 100.0%
1.Primary Outcome
Title Recurrence-free Survival Time
Hide Description The 2-year recurrence-free survival (RFS) time for patients treated with neoadjuvant cisplatin and gemcitabine chemotherapy followed by surgery in high risk upper tract urothelial carcinoma.
Time Frame 2 years after participant surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Due to poor patient enrollment the primary objective was not able to be analyzed.
Arm/Group Title Neoadjuvant Gemcitabine and Cisplatin
Hide Arm/Group Description:
Neoadjuvant Cisplatin and Gemcitabine: Cisplatin 70 mg/m2 through IV for 60 minutes on day 1 of each cycle. Gemcitabine 1,000 mg/m2 IV for 30 minutes on days 1 and 8 during each cycle. Treatment is expected to continue for up to 4 cycles. Chemotherapy will be followed by radical nephroureterectomy within 6 weeks (+/- 2 weeks) from the last date of chemotherapy.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Number of Patients With Pathologic T0/Tis/Ta N0.
Hide Description The proportion of patients with pathologic T0/Tis/Ta N0.
Time Frame 51 months
Hide Outcome Measure Data
Hide Analysis Population Description
Due to poor patient enrollment this outcome was not able to be analyzed.
Arm/Group Title Neoadjuvant Gemcitabine and Cisplatin
Hide Arm/Group Description:
Neoadjuvant Cisplatin and Gemcitabine: Cisplatin 70 mg/m2 through IV for 60 minutes on day 1 of each cycle. Gemcitabine 1,000 mg/m2 IV for 30 minutes on days 1 and 8 during each cycle. Treatment is expected to continue for up to 4 cycles. Chemotherapy will be followed by radical nephroureterectomy within 6 weeks (+/- 2 weeks) from the last date of chemotherapy.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description The safety of neoadjuvant chemotherapy.
Time Frame 9 years
Hide Outcome Measure Data
Hide Analysis Population Description
Due to poor patient enrollment this outcome was not able to be analyzed.
Arm/Group Title Neoadjuvant Gemcitabine and Cisplatin
Hide Arm/Group Description:
Neoadjuvant Cisplatin and Gemcitabine: Cisplatin 70 mg/m2 through IV for 60 minutes on day 1 of each cycle. Gemcitabine 1,000 mg/m2 IV for 30 minutes on days 1 and 8 during each cycle. Treatment is expected to continue for up to 4 cycles. Chemotherapy will be followed by radical nephroureterectomy within 6 weeks (+/- 2 weeks) from the last date of chemotherapy.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Neoadjuvant Gemcitabine and Cisplatin
Hide Arm/Group Description Neoadjuvant Cisplatin and Gemcitabine: Cisplatin 70 mg/m2 through IV for 60 minutes on day 1 of each cycle. Gemcitabine 1,000 mg/m2 IV for 30 minutes on days 1 and 8 during each cycle. Treatment is expected to continue for up to 4 cycles. Chemotherapy will be followed by radical nephroureterectomy within 6 weeks (+/- 2 weeks) from the last date of chemotherapy.
All-Cause Mortality
Neoadjuvant Gemcitabine and Cisplatin
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Neoadjuvant Gemcitabine and Cisplatin
Affected / at Risk (%) # Events
Total   1/1 (100.00%)    
Investigations   
Creatinine Increased  1/1 (100.00%)  1
Metabolism and nutrition disorders   
Dehydration  1/1 (100.00%)  1
Renal and urinary disorders   
Acute Kidney Injury  1/1 (100.00%)  1
Respiratory, thoracic and mediastinal disorders   
Hypoxia  1/1 (100.00%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Neoadjuvant Gemcitabine and Cisplatin
Affected / at Risk (%) # Events
Total   0/1 (0.00%)    
The study was terminated prematurely due to poor patient accrual. Study objectives were not analyzed.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Ajjai Alva
Organization: University of Michigan Comprehensive Cancer Center
Phone: 734-647-8921
EMail: ajjai@umich.edu
Layout table for additonal information
Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT01663285     History of Changes
Other Study ID Numbers: UMCC 2012.038
HUM00062285 ( Other Identifier: University of Michigan IRBMED )
First Submitted: July 24, 2012
First Posted: August 13, 2012
Results First Submitted: September 11, 2014
Results First Posted: September 18, 2014
Last Update Posted: December 3, 2015