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

• Status: Withdrawn
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lahey Clinic
• Treatments: Cisplatin; Gemcitabine

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