Sunitinib Treatment Of Renal Adjuvant Cancer (S-TRAC): A Randomized Double Blind Phase 3 Study Of Adjuvant Sunitinib VS. Placebo In Subjects At High Risk Of Recurrent RCC
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Kidney Neoplasms
Both
Kidney Neoplasms
Trial Information
Sunitinib Treatment Of Renal Adjuvant Cancer (S-TRAC): A Randomized Double Blind Phase 3 Study Of Adjuvant Sunitinib VS. Placebo In Subjects At High Risk Of Recurrent RCC
Inclusion Criteria:
- High risk renal cancer per modified UISS criteria
- Eastern Cooperative Oncology Group (ECOG) 0-2
- predominant clear cell histology
- No prior anti-cancer treatment
- Kidney tumor has been removed
- No evidence of macroscopic disease following surgery
Exclusion Criteria:
- Histologically undifferentiated carcinomas or collecting duct carcinoma, lymphoma,
sarcoma or subjects with metastatic renal sites.
- Diagnosis of any second malignancy within the last 5 years, except basal cell
carcinoma, squamous cell skin cancer, or in situ carcinoma of the cervix uteri that
has been adequately treated with no evidence of recurrent disease for 12 months
- known HIV or Hepatitis
- any severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or study
drug administration
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Disease-free survival comparing sunitinib with placebo
Outcome Time Frame:
36 months
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
A6181109
NCT ID:
NCT00375674
Start Date:
July 2007
Completion Date:
June 2017
Related Keywords:
- Kidney Neoplasms
- Neoplasms
- Carcinoma, Renal Cell
- Kidney Neoplasms
Name | Location |
|---|---|
| Pfizer Investigational Site | Blendora, California 91740 |
| Pfizer Investigational Site | Atlanta, Georgia 30342 |
| Pfizer Investigational Site | Bronx, New York 10461 |
| Pfizer Investigational Site | Asheville, North Carolina 28801 |
| Pfizer Investigational Site | Kingston, Pennsylvania 18704-5535 |
| Pfizer Investigational Site | Easley,, South Carolina 29640 |
| Pfizer Investigational Site | Shreveport, Louisiana 71103 |
| Pfizer Investigational Site | Salt Lake City, Utah 84112 |
