The purpose of this study is to see if getting chemotherapy with Gemcitabine and Cisplatin for four 21 day cycles for a total of 12 weeks can help shrink the tumor before undergoing surgery for kidney cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
57
Patients will receive four cycles of GC administered every 21 days. Gemcitabine 1,000 mg/m2 and Cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8. A total of four cycles of therapy will be administered at 21 day intervals followed by radical nephroureterectomy or distal ureterectomy.
Mayo Clinic - Arizona
Scottsdale, Arizona, United States
Hartford Hospital (Data Collection Only)
Hartford, Connecticut, United States
Memorial Sloan Kettering at Basking Ridge
Basking Ridge, New Jersey, United States
Pathologic Response Rate (<pT2)
of neoadjuvant Gemcitabine and Cisplatin/GC regimen in patients with upper tract high-grade urothelial carcinoma. Pathologic response to neoadjuvant GC is defined as the absence of high-grade carcinoma (\<pT2 disease) and the absence of microscopic lymph node metastases (N0) on the final nephroureterectomy specimen.
Time frame: up to 2 years
Percentage of Participants With Progression Free Survival Rate
will be estimated using the methods of Kaplan and Meier in patients with upper tract high-grade urothelial carcinoma with neoadjuvant GC followed by radical nephroureterectomy.
Time frame: 2 years
Overall Survival
will be estimated using the methods of Kaplan and Meier in patients with upper tract high-grade urothelial carcinoma treated with neoadjuvant GC followed by radical nephroureterectomy.
Time frame: 2 years
Number of Participants Evaluated for Toxicity
of neoadjuvant Gemcitabine and Cisplatin in this setting. Toxicity will be graded according to the National Cancer Institute Common Toxicity Criteria version 4.0.
Time frame: 2 years
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Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, United States
Memorial Sloan Kettering Westchester
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Memorial Sloan Kettering Nassau (Consent and Follow-Up only)
Uniondale, New York, United States
Lehigh Valley Health Network (Data Collection Only)
Allentown, Pennsylvania, United States