|Full title:||RAD001 and ZOledronic acid in Renal cell carcinoma patients with bone metastases – a randomised phase II trial|
|Cancer type:||Renal cell|
|Status:||Closed (30 participants recruited)|
|The main purpose of this study is to assess if RAD001 plus zoledronic acid, is a more effective treatment for patients with renal cell carcinoma and bone metastases compared to RAD001 alone.
Participants will be allocated to one of these two treatments with equal chances of each treatment being the one received.
Patients’ must have previously untreated advanced renal cell carcinoma, with at least one measurable bone metastases. Patients must be aged 18 years or older.
Zoledronic acid will be given as an intravenous venous (IV) infusion over 15 minutes once every 28 days. RAD001 will be taken by mouth, in tablet form, 10 mg every day.
Participants will undergo tests (medical history, physical examinations, blood & urine tests, electrocardiograms (ECG), a dental examination and Computerised Tomography (CT) scan to confirm they can enter the study.
After the 12 week bone specific assessment period, subjects continue on therapy, on the treatment arm to which they are allocated, until one of the following criteria applies:
a) Disease progression
· Palmerston North
|Lead Investigator:||Dr Reuben Broom|
|Contact:||Sarah Benge (firstname.lastname@example.org)|
|Trial Registry reference:||ACTRN12609000980235 (click for more details)|
|Publications:||Broom RJ, Hinder V, Sharples K, Proctor J, Duffey S, Pollard S, Fong PCC, Forgeson G, Harris DL, Jameson MB, O’Donnell A, North RT, Deva S, Hanning FJ, Grey A, Findlay MPN. Everolimus and zoledronic acid in patients with renal cell carcinoma with bone metastases: A randomized first-line phase II trial. Clinical Genitourinary Cancer. 2015 Feb; 13(1): 50-58.|