NAXIVA
Research type
Research Study
Full title
Phase II neoadjuvant study of Axitinib for reducing extent of venous tumour thrombus in clear cell renal cell cancer with venous invasion.
IRAS ID
223309
Contact name
Grant Stewart
Contact email
Sponsor organisation
Common Services Agency (CSA)
Eudract number
2017-000619-17
ISRCTN Number
ISRCTN96273644
Duration of Study in the UK
2 years, 3 months, 1 days
Research summary
Patients who have been diagnosed with kidney cancer with cancer invasion into the large blood vessels draining the kidney will, if they are fit enough, undergo surgery in an attempt to remove all disease. Due to the risk associated with this surgery the 5 year survival rates are poor, at 40-65% in patients where their cancer has not spread (non-metastatic) and 0-17% in patients where their cancer has spread (metastatic).
Therefore in NAXIVA we will study how effective the drug Axitinib is at reducing the extent of the cancer invasion into the large blood vessels draining the kidney with a view to reducing the extent of surgery required to then remove the cancerous tissue. The possibility of less extensive surgery may mean a smaller incision and a less invasive operation on the inside of the patient’s abdomen. If this is the case, we hope for fewer complications (such as less blood loss and less chance of requiring a blood transfusion), a shorter hospital stay and faster recovery time at home.
When deemed eligible for the NAXIVA trial, patients will receive axitinib for 8 weeks prior to surgery. Axitinib is a tyrosine kinase inhibitor. Tyrosine kinase inhibitors are a type of drug that act by blocking certain proteins called tyrosine kinases which cause the cancer cells to grow. The study is looking to see how effective the axitinib is at preventing cancer cells from growing and to see if this means that patients need less extensive surgery.
NAXIVA is a single arm, open label, phase II feasibility study of 20 patients with clear cell renal cell cancer with venous tumour thrombus. Patients will be recruited from multiple sites across the UK over a 24 month recruitment period.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
17/EE/0240
Date of REC Opinion
2 Aug 2017
REC opinion
Further Information Favourable Opinion