A Phase II Metastasectomy Study for Patients With Renal Cell Carcinoma.
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.
Study Visits:
Right before you have surgery, the following tests and procedures will be performed:
- Your vital signs will be measured.
- Your performance status will be recorded.
- Blood (about 2-3 teaspoons) and urine will be collected for routine tests.
- You will be asked about any side effects you may have experienced since your last
visit.
About 1 month after the surgery, the following tests and procedures will be performed:
- You will be asked about any drugs and/or treatments you may be receiving.
- You will be asked about any side effects you may have experienced since your last
visit.
- 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.
Every 3 months for the 1st year after surgery (Year 1), every 4 months for the 2nd year
after surgery (Year 2), and again every 6 months for the 3rd through 5th years after surgery
(Years 3-5), the following tests and procedures will be performed:
- You will be asked about any drugs and/or treatments you may be receiving.
- You will be asked about any side effects you may have experienced since your last
visit.
- 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 remain on study 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.
This is an investigational study. Up to 56 patients will take part in this study. All will
be enrolled at M. D. Anderson.
Observational
Observational Model: Case-Only, Time Perspective: Prospective
24-week Progression free/relapse free survival rate
Every 3 months for the first year, every 4 months during the second year, every 6 months in the third through fifth year.
No
Eric Jonasch, MD
Study Chair
UT MD Anderson Cancer Center
United States: Institutional Review Board
2009-0038
NCT00918775
June 2009
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |