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

Phase 2

Withdrawn

• Conditions: Transitional Cell Carcinoma
• Interventions: Drug: Gemcitabine and cisplatin; Other: Retrospective comparison

• Registration Number: NCT00696007
• Lead Sponsor: Lahey Clinic

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 Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-06-10
• Study First Submitted QC: 2008-06-11
• Study First Posted: 2008-06-12
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-16
• Last Update Posted: 2012-02-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Gemcitabine and cisplatin	A neoadjuvant chemotherapy (gemcitabine and cisplatin) regimen administered before surgery-nephroureterectomy for upper tract TCC
2	Retrospective comparison	A retrospective cohort group (approximately 60 subjects) identified from an institutional cancer registry who have undergone a nephroureterectomy alone over the past five years

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Overall survival compared to institutional historical cohort of subjects who have undergone a nephroureterectomy alone.	5 years

Trial Locations

Locations (1)

Lahey Clinic, Inc.; 🇺🇸 Burlington, Massachusetts, United States