drugset / Trial / NCT00492258
Sorafenib in Treating Patients at Risk of Relapse After Undergoing Surgery to Remove Kidney Cancer
RandomizedOpen-labelTreatment
Summary
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sorafenib after surgery may kill any tumor cells that remain after surgery. It is not yet known whether sorafenib is more effective than a placebo in treating kidney cancer. PURPOSE: This randomized phase III trial is studying sorafenib to see how well it works compared with a placebo in treating patients at risk of relapse after undergoing surgery to remove kidney cancer.
Timeline
- Start
- 2007-06
- Primary completion
- 2012-08
- Completion
- 2012-12
Publications
- Eisen T, Frangou E, Oza B, Ritchie AWS, Smith B, Kaplan R, Davis ID, Stockler MR, Albiges L, Escudier B, Larkin J, Bex A, Joniau S, Hancock B, Hermann GG, Bellmunt J, Hodgkinson E, Stewart GD, Barber J, Brown J, McMenemin R, Nathan P, Pickering LM, Parmar MKB, Meade A. Adjuvant Sorafenib for Renal Cell Carcinoma at Intermediate or High Risk of Relapse: Results From the SORCE Randomized Phase III Intergroup Trial. J Clin Oncol. 2020 Dec 1;38(34):4064-4075. doi: 10.1200/JCO.20.01800. Epub 2020 Oct 14.
- Blinman PL, Davis ID, Martin A, Troon S, Sengupta S, Hovey E, Coskinas X, Kaplan R, Ritchie A, Meade A, Eisen T, Stockler MR. Patients' preferences for adjuvant sorafenib after resection of renal cell carcinoma in the SORCE trial: what makes it worthwhile? Ann Oncol. 2018 Feb 1;29(2):370-376. doi: 10.1093/annonc/mdx715.
- Fairfax BP, Pratap S, Roberts IS, Collier J, Kaplan R, Meade AM, Ritchie AW, Eisen T, Macaulay VM, Protheroe A. Fatal case of sorafenib-associated idiosyncratic hepatotoxicity in the adjuvant treatment of a patient with renal cell carcinoma. BMC Cancer. 2012 Dec 11;12:590. doi: 10.1186/1471-2407-12-590.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sorafenib | Small molecule | 400 mg | Oral |