Status:
WITHDRAWN
Neoadjuvant Chemotherapy Plus Nephroureterectomy for Locally Advanced Upper Tract Transitional Cell Cancer
Lead Sponsor:
Lahey Clinic
Conditions:
Transitional Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to test the effectiveness, safety and side effects of two chemotherapy drugs (gemcitabine and cisplatin) when combined with surgery after chemotherapy for patients with up...
Detailed Description
This study will look at improving overall survival of those undergoing nephroureterectomy for upper tract TCC (transitional cell carcinoma, comparing the pathological response of tumors treated with N...
Eligibility Criteria
Inclusion
- ECOG performance status 0-2
- Estimated GFR\>60
- High grade TCC on initial biopsy
- Clinical stage T1-T3, Nx, Mx based on the AJCC Classification system
- TCC confined to the ureter or renal pelvis
- Grade II neuropathy or less
Exclusion
- Any other malignancy over the previous five years with a risk of relapse that exceeds 30%
- History of previous cystectomy
- Evidence of metastatic disease
- History of pelvic irradiation or prior chemotherapy
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00696007
Start Date
April 1 2008
End Date
April 1 2010
Last Update
February 17 2012
Active Locations (1)
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1
Lahey Clinic, Inc.
Burlington, Massachusetts, United States, 01805