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Randomized Comparison of Sequential Therapies With Sunitinib and Sorafenib in Advanced Renal Cell Carcinoma

Phase 3
20 Years
80 Years
Open (Enrolling)
Metastatic Renal Cell Carcinoma

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Trial Information

Randomized Comparison of Sequential Therapies With Sunitinib and Sorafenib in Advanced Renal Cell Carcinoma

Inclusion Criteria:

- Age: 20-80 years old, both inclusive

- ECOG performance status of 0, 1, or 2

- MSKCC risk of favorable or intermediate

- Histologically confirmed renal cell carcinoma

- No ischemic heart disease

- Laboratory findings meet the following criteria:

1. Respiratory function: %VC, 80% and FEV1.0,70%

2. Hematology: white blood cell count4,000/mm3, platelet count100,000/mm3

3. Clinical chemistry: GOT and GPT within the normal range of each medical
institution; total bilirubin <1.5 x ULN

4. Serum creatinin <2.0mg/dl, blood urea nitrogen (BUN) <25mg/dl

5. Echocardiographic estimation of left ventricular ejection fraction is higher
than the lower limit of reference range of each medical institution.

Exclusion Criteria:

- History of any other malignancy

- Central nervous system metastases. However, patients who remain asymptomatic, have no
new or enlarging lesion in the CNS within 6 months of enrollment in this study, and
require no corticosteroids may be enrolled.

- History of cardiac infarction, unstable angina, congestive heart failure, or
symptomatic peripheral vascular disease within 12 months of enrollment

- History of cerebrovascular disorder including transient ischemic attack (TIA)

- Pregnancy or possible pregnancy at any time during the study

- Ongoing grade 2 adverse event prior treatment

- Prior treatment with any anticancer therapy including cytokine therapy such as
interferon-alpha and interleukin-2

- Prior treatment with mTOR inhibitor

- Prior treatment with sunitinib or sorafenib

- Treatment with an test drug in a clinical research within 4 weeks of enrollment in
this study

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression free survival in first-line treatment

Outcome Description:

From date of randomization until the date of first documented progression of the first line treatment or date of death from any cause, whichever came first, assessed up to 36 months.

Outcome Time Frame:

Time of progression in first line treatment

Safety Issue:


Principal Investigator

Yoshihiko Tomita, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Yamagata University Faculty of Medicine


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

January 2010

Completion Date:

December 2015

Related Keywords:

  • Metastatic Renal Cell Carcinoma
  • renal cell carcinoma
  • sorafenib
  • sunitinib
  • crossover
  • Carcinoma
  • Carcinoma, Renal Cell