Neoadjuvant Chemotherapy Plus Nephroureterectomy for Locally Advanced Upper Tract Transitional Cell Cancer

Withdrawn before enrolling · Phase 2

Conditions studied: Transitional Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT00696007

Run by

Lahey Clinic

People needed

0

Starts

2008-04-01

Expected to finish

2010-04-01

Last updated by the study team

2012-02-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Lahey Clinic, Inc. — Burlington, Massachusetts, United States

Full record on ClinicalTrials.gov

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