Why should I participate in the Record-2 Study?

Patients in the RECORD-2 study will be active participants in contributing to kidney cancer research that may help other patients in the future. Treatment in this clinical study may shrink or slow the growth of your tumor. However, you must also be aware that participation in this study may not benefit you.

What can I expect while participating in this study?

While participating in this clinical study you may be at risk for side effects. As with any medication, side effects may vary from person to person. 

The most common possible side effects of the study drug RAD001 are skin changes (rash) including redness, itching, or irritation; mouth lining changes (stomatitis) revealed through redness, irritation, swelling in the mouth, or mouth ulcers; fatigue, nausea, decrease of appetite (anorexia), headache, vomiting, diarrhea, constipation, abdominal distension, and occasionally infections.

Many side effects go away shortly after RAD001 is stopped, but in some cases side effects may be serious and/or long-lasting. Remember to report any side effects to your doctor or nurse.

In addition, pneumonitis, a condition that affects your lungs, has been reported in some patients taking RAD001. Frequently, pneumonitis resolves once you stop taking the medication. Your doctor will check for this condition often. You should contact your doctor immediately if you experience sudden unusual symptoms such as shortness of breath, coughing, or fever.

What is the time commitment?

If you join the study you will be asked to come to the doctor’s study site every 2 weeks for about 2 years. Each visit may take about 4 hours or less.

To see if you are eligible to participate in a Novartis research study, click on the below link.