ASSURE: adjuvant sorafenib or sunitinib for ufavorable renal carcinoma

eagle-i ID

Resource Type

Properties

1. ClinicalTrials.gov url

   http://www.clinicaltrials.gov/ct2/show/NCT00326898?term=ECOG-E2805&rank=1

2. Intervention

   Sunitinib

3. Intervention

   Sorafenib

4. Intervention

   Sutent

5. Intervention

   Nexavar

6. Intervention

   Adjuvant therapy

7. Resource Description

   Surgery is the primary treatment for most cases of kidney cancer. While surgery alone often cures patients with early stage disease, individuals with more advanced disease have an increased risk of cancer recurrence after surgery. In this trial, patients who have tumors that can be surgically removed and who are at high risk for recurrence are given sunitinib (Sutent®), sorafenib (Nexavar®), or a placebo as postoperative (adjuvant) therapy. Patients given the placebo will be receiving the current standard of care for their condition, which is no adjuvant therapy. Sunitinib and sorafenib are targeted therapies that block cell proliferation and the growth of new blood vessels to tumors (a process called angiogenesis). Angiogenesis is important for the growth and spread of malignant kidney tumors and blocking it may help prevent the growth of cancer cells that remain after surgery.

8. Contact

   Berenberg, Jeffrey

9. PI

   Berenberg, Jeffrey

10. Topic

    kidney cancer

11. Study Population

    Males and females age 18 and older with histologically or cytologically confirmed renal cell carcinoma, including clear cell carcinoma and nonclear cell carcinoma; no collecting duct or medullary carcinomas.

12. Website(s)

    http://www.cancer.gov/clinicaltrials/featured/trials/ecog-e2805

13. Website(s)

    http://www.cancer.gov/clinicaltrials/search/view?cdrid=478976&version=healthprofessional

14. Funded by

    Cancer Trials Support Unit

15. Phase

    Phase 3 clinical trial

16. Performed by

    Clinical Protocol & Data Management Shared Resource