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Phase II Trial of Adjuvant Sutent for Patients With High Risk Urothelial Carcinoma After Neoadjuvant Chemotherapy and Cystectomy


Phase 2
18 Years
N/A
Not Enrolling
Both
Urothelial Carcinoma, Bladder Cancer

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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