Study on Axitinib's Role in Improving Kidney Surgery Outcomes for Renal Cancer
Sponsor: University of California, San Diego
ClinicalTrials ID:NCT03438708
This clinical trial is exploring whether the drug axitinib can help make kidney-sparing surgery possible for patients with clear cell renal cell carcinoma (RCC) who currently cannot have this surgery due to the tumor's location or concerns about kidney function.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
The study aims to see if taking axitinib before surgery can safely shrink kidney tumors, making it easier to perform a partial nephrectomy (removal of part of the kidney) in patients with localized clear cell renal cell carcinoma (RCC). This is especially for those who need this type of surgery but can't have it right now because of the tumor's position or kidney function issues. The trial will involve 50 participants and will assess changes in tumor size and complexity, as well as the safety of the treatment.
Description
The main goal of this study is to find out if axitinib can help make partial kidney removal surgery possible for patients with complex kidney tumors where this surgery was previously not considered safe. Researchers will look at how the tumor size changes, the safety of the treatment, and how it affects kidney function.
They will measure:
- Changes in tumor size and complexity
- Whether tumors near the kidney's main blood vessels can be moved away from these vessels
- Changes in kidney function, including the need for dialysis and changes in kidney filtration rates
Safety will be monitored by looking at:
- Serious complications during surgery
- The need for multiple blood transfusions
Eligibility Criteria
Inclusion Criteria
- Have localized clear cell renal carcinoma without cancer spread to other parts of the body
- Need kidney-sparing surgery due to:
- Existing chronic kidney disease (stage 3, GFR <60 ml/min/1.73m2), or having only one functioning kidney, or cancer in both kidneys
- Tumor complexity score of 10 or higher, or tumor close to main kidney blood vessels
- Full kidney removal would lead to severe kidney disease (stage 3b, GFR <45 ml/min/1.73m2)
- Be 18 years or older
- Have a performance status score of 70 or higher, indicating the ability to care for oneself
- Have adequate organ function based on specific blood tests
- Agree to participate and follow study procedures, including signing a consent form
Exclusion Criteria
- Have cancer that has spread to other parts of the body
- Elective kidney-sparing surgery
- Have a different type of kidney cancer
- Have had previous treatments or radiation for RCC
- Have had significant bleeding within 4 weeks before starting the study
- Have ongoing heart rhythm problems or a prolonged QT interval on an EKG
- Be pregnant or breastfeeding, or not using effective birth control
- Have severe medical or psychiatric conditions that could increase risks or interfere with the study
- Have uncontrolled high blood pressure
- Have heart failure classified as NYHA class III or higher
- Have uncontrolled thyroid problems
- Have had recent blood clots in arteries or veins
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UC San Diego Moores Cancer Center | 92093 | La Jolla | California |
| Cleveland Clinic | 44195 | Cleveland | Ohio |
Get This Program In Your Inbox
Receive detailed information about this treatment opportunity to review with your healthcare provider.