Neoadjuvant Chemotherapy Plus Nephroureterectomy for Locally Advanced Upper Tract Transitional Cell Cancer
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 Neoadjuvant Chemotherapy (gemcitabine and cisplatin) before surgery.
There have been reported studies of neoadjuvant chemotherapy in the treatment of upper tract
TCC, there have been no studies to date that include the chemotherapy agents gemcitabine and
cisplatin that are currently indicated in treating TCC of the bladder in the neoadjuvant and
adjuvant setting. These agents have been proven to have a better overall safety profile and
tolerability allowing more patients to complete their regimens. Secondarily, study will
compare disease free overall survival among patients treated with neoadjuvant chemotherapy
and surgery versus surgery alone. This study may elucidate the potential benefit of these
agents when treating TCC of the upper tracts and may provide a survival advantage in this
specific patient population as compared to a historical cohort.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Neoadjuvant chemotherapy (Gemcitabine and Cisplatin) Regime (3 cycles) before Nephroureterectomy
5 years: follow ups 1st year/every 4 mths, 2nd & 3rd year to every 6 months, 4th & 5th yr-annually for patients who remain disease free
Christopher G. Tretter, M.D.
Lahey Clinic, Inc.
United States: Institutional Review Board
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