IRB #

IRB00008637

Title

Phase II Clinical Trial Of Neoadjuvant Chemotherapy (NAC) In Upper Tract Urothelial Carcinoma (UTUC)

Principal Investigator

Theresa Koppie

Study Purpose

The purpose of this study is to determine whether the addition of chemotherapy treatment prior to surgery will help prevent tumor from returning.

Medical Condition(s)

Upper Tract Urothelial Carcinoma (UTUC)

Eligibility Criteria

Histologically confirmed upper tract urothelial carcinoma; All patients must be considered a candidate for surgery with curative intent (nephroureterectomy or distal ureterectomy) with lymph node dissection; must have a performance status of 0 - 2 by Eastern Cooperative Oncology Group (ECOG) criteria; Patients must have granulocyte count > 1,500/mm3, platelet > 100,000/mm3, and hemoglobin > 9.0 g/dl within 14 days prior to registration

Age Range

18 - 99

Healthy Volunteers Needed

No

Duration of Participation

Subjects will receive chemotherapy treatment for up to three months after which they will have surgery. After that, they will have follow-up exams every 4 months for the first year from date of your surgery, then every 6 months in the second and third year after surgery, then annually for the next two years.

Minors Included

No

Contact

Deirdre Nauman
503-494-3078
naumand@ohsu.edu

Sponsor

Investigator initiated, please note the coordinating center is the Univeristy of Michigan

Recruitment End

08/01/2015

Compensation Provided

No