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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
Open (Enrolling)
Both
Kidney Neoplasms

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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 SiteBlendora, California  91740
Pfizer Investigational SiteAtlanta, Georgia  30342
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteAsheville, North Carolina  28801
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535
Pfizer Investigational SiteEasley,, South Carolina  29640
Pfizer Investigational SiteShreveport, Louisiana  71103
Pfizer Investigational SiteSalt Lake City, Utah  84112