Metastasectomy Study in Renal Cell Carcinoma (RCC)
The goal of this clinical research study is to learn if the surgical removal of your primary tumor or the parts of the cancer that has spread to other parts of the body is a good method for treating patients who have kidney cancer. Only the parts of the cancer that has spread will be removed during the surgery.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||A Phase II Metastasectomy Study for Patients With Renal Cell Carcinoma.|
- 24-week Progression free/relapse free survival rate [ Time Frame: Every 3 months for the first year, every 4 months during the second year, every 6 months in the third through fifth year. ] [ Designated as safety issue: No ]Primary outcome is binary indicator that patient is alive with no evidence of disease progression (either progression or relapse) 24 weeks post surgery (response), denoted by Y. Time of surgery considered time 0. Baseline covariates examined for their ability to predict p = Pr(Y=1) include binary variables observed at first diagnosis, at trial entry, and type of therapeutic intervention.
|Study Start Date:||June 2009|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Kidney cancer patients being considered for surgery
Evaluation during and after surgery: vital signs, performance status, physical exam, chest x-ray, CT and MRI plus health questions.
This research study is designed to follow your progress after the surgery is complete. You will not receive any drugs or treatment as part of this research study. You may however receive non-study treatment after your surgery.
Every 6 months for 5 years after surgery, the following tests and procedures will be performed:
- You will have a physical exam, including measurement of your weight and vital signs.
- Your performance status will be recorded.
- Blood (about 2-3 teaspoons) and urine will be collected for routine tests.
- You will have a chest x-ray and CT scans or MRI scans of your chest, stomach area, and brain to check the status of the disease.
- If the study doctor thinks it is necessary, you will have a bone scan to check the status of the disease.
Length of Study:
You will have study visits for up to 5 years after the surgery is complete. You will be taken off study early if the disease gets worse, or if the study doctor thinks that it is no longer in your best interest to continue.
About every 6 months after your last study visit, the study staff will either review your medical records or contact you by phone or email to collect information about your health, to see how you are doing, and what anti-cancer treatments you may have received. If you are contacted by phone, the call should only last about 5 minutes each time.
This is an investigational study. Up to 120 patients will take part in this study. All will be enrolled at MD Anderson.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00918775
|Contact: Eric Jonasch, MD||713-792-2830|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Study Chair:||Eric Jonasch, MD||M.D. Anderson Cancer Center|