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


Phase 2
18 Years
N/A
Not Enrolling
Both
Transitional Cell Carcinoma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Neoadjuvant chemotherapy (Gemcitabine and Cisplatin) Regime (3 cycles) before Nephroureterectomy

Outcome Time Frame:

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

Safety Issue:

Yes

Principal Investigator

Christopher G. Tretter, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Lahey Clinic, Inc.

Authority:

United States: Institutional Review Board

Study ID:

2008-039

NCT ID:

NCT00696007

Start Date:

April 2008

Completion Date:

April 2010

Related Keywords:

  • Transitional Cell Carcinoma
  • Upper GU Tract Transitional Cell Carinoma
  • Nephroureterectomy
  • Chemotherapy
  • Gemcitabine
  • Cisplatin
  • Carcinoma
  • Carcinoma, Transitional Cell

Name

Location
Lahey Clinic, Inc. Burlington, Massachusetts  01805