Brief Title
Neoadjuvant Chemotherapy Plus Nephroureterectomy for Locally Advanced Upper Tract Transitional Cell Cancer
Official Title
Neoadjuvant Chemotherapy Plus Nephroureterectomy for Locally Advanced Upper Tract Transitional Cell Cancer
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 upper urinary tract cancer. The hypothesis is that undergoing chemotherapy prior to surgery will have a beneficial effect on prognosis and may improve overall survival as in patients with bladder cancer, and will allow better tolerance of chemotherapy than if it were given after surgery.
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 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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Neoadjuvant chemotherapy (Gemcitabine and Cisplatin) Regime (3 cycles) before Nephroureterectomy
Secondary Outcome
Overall survival compared to institutional historical cohort of subjects who have undergone a nephroureterectomy alone.
Condition
Transitional Cell Carcinoma
Intervention
Gemcitabine and cisplatin
Study Arms / Comparison Groups
1
Description: A neoadjuvant chemotherapy (gemcitabine and cisplatin) regimen administered before surgery-nephroureterectomy for upper tract TCC
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
0
Start Date
April 2008
Completion Date
April 2010
Primary Completion Date
April 2010
Eligibility Criteria
Inclusion Criteria: - 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 Criteria: - 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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Christopher G. Tretter, M.D., ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00696007
Organization ID
2008-039
Responsible Party
Sponsor
Study Sponsor
Lahey Clinic
Study Sponsor
Christopher G. Tretter, M.D., Principal Investigator, Lahey Clinic, Inc.
Verification Date
February 2012