Phase II Clinical Trial Of Neoadjuvant Chemotherapy (NAC)In Upper Tract Urothelial Carcinoma (UTUC)
In recent years, the combination of gemcitabine and cisplatin given every 21 days
(gemcitabine on days 1 and 8 only) has been used in trials and routine clinical practice.
Additionally, surgery, primarily radical nephroureterectomy (RNU) with bladder cuff removal,
is the current standard treatment for invasive upper tract urothelial carcinoma.
Upper tract urothelial cancer (UTUC) or urothelial cancer arising in the pelvicalyceal or
ureteral locations is a lethal cancer accounting for 5% of all urothelial cancers. In
urothelial cancer of the bladder, randomized clinical trials and meta-analyses have shown a
survival advantage with neoadjuvant cisplatin-based chemotherapy. It is conceivable that a
similar approach may benefit patients with UTUC.
Both Gemcitabine and Cisplatin are approved by the FDA. Cisplatin is approved for use in
urothelial cancer. Gemcitabine is FDA approved to be used alone or with other drugs to
treat breast, non-small lung, ovarian, and pancreatic cancers. Gemcitabine is not approved
by the FDA for urothelial cancer, but it is typically used together with Cisplatin in trials
and routine clinical practice for treating urothelial cancer.
Exploratory integrative tumor sequencing:
The biology of UTUC is poorly understood due to the relative rarity of the disease and the
lack of comprehensive genomic and translational studies. This trial offers a rare
opportunity to apply high-throughput sequencing techniques in UTUC to detect several classes
of cancer mutations including structural rearrangements, copy number alterations, point
mutations, and gene expression alterations. This research could help to develop future
studies in UTUC to help researchers understand more about UTUC and how to treat it.
Additionally, we may identify a potentially important result from DNA samples from subjects
that could possibly help manage their cancer better by pursing a different cancer therapy
rather than the study therapy.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The 2-year recurrence-free survival (RFS) rate of patients treated with neoadjuvant cisplatin and gemcitabine chemotherapy followed by surgery in high risk upper tract urothelial carcinoma.
2 years after participant surgery
Ajjai S. Alva, M.D.
University of Michigan
United States: Institutional Review Board
|Baylor College of Medicine||Houston, Texas 77030|
|University of Michigan||Ann Arbor, Michigan 48109-0624|
|University of Utah||Salt Lake City, Utah|
|Oregon Health Sciences University||Portland, Oregon|
|University of Rochester||Rochester, New York 14642|
|University of Southern California||Los Angeles, California 90033|