Trial Information
Phase II Trial of Adjuvant Sutent for Patients With High Risk Urothelial Carcinoma After Neoadjuvant Chemotherapy and Cystectomy
Inclusion Criteria:
- Histologic diagnosis of bladder carcinoma (>50% urothelial carcinoma)
- Prior treatment with at least one cycle of platin-based neoadjuvant chemotherapy
- Prior treatment with radical cystectomy revealing pT3NxM0 or pTanyN+M0
- ECOG performance status of 0-1 (Appendix 2).
- No evidence of metastases within 4 weeks of registration
- Adequate organ and marrow function obtained within 14 days of registration
Exclusion Criteria:
- Severe or uncontrolled acute or chronic medical or psychiatric condition
- Prior antiangiogenic therapy
- Prior pelvic radiation for bladder cancer
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Disease Free Survival
Outcome Time Frame:
2- year
Safety Issue:
No
Authority:
United States: Institutional Review Board
Study ID:
HUM00030127
NCT ID:
NCT01042795
Start Date:
September 2009
Completion Date:
January 2013
Related Keywords:
- Urothelial Carcinoma
- Bladder Cancer
- sunitinib
- bladder neoplasm
- adjuvant treatment
- disease free survival
- Patients with extravesical tumor (pT2-4,Nany, M0 or pTanyN+M0) after cystectomy and platin-based neoadjuvant chemotherapy
- Urinary Bladder Neoplasms
- Carcinoma
- Carcinoma, Transitional Cell
Name | Location |
University of Michigan |
Ann Arbor, Michigan 48109-0624 |