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Metastasectomy Study in Renal Cell Carcinoma (RCC)
Conditions
Kidney Cancer
Conditions: official terms
Carcinoma, Renal Cell
Conditions: Keywords
Renal Cell Carcinoma, RCC, Kidney, Metastasectomy, Surgery, Tumor Removal
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Case-Only, Time Perspective: Prospective
Intervention
Name: Evaluation
Type: Other
Overall Status
Recruiting
Summary
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.
Detailed Description
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:
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.
Long-Term Follow-Up:
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.
Study Visits:
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.
Long-Term Follow-Up:
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: N/A
Gender: Both
Criteria: Inclusion Criteria:
1. Patients with histologically or cytologically confirmed renal cell carcinoma (RCC).
2. 2. Patients have clinical reasons for undergoing a surgical resection of tumor. There are two main categories of patients: a)Patients with fully resectable disease as defined by lesions accessible by a surgeon during no more than two separate surgical sessions, and are expected to be rendered surgically no evidence of disease (NED). b) Patients undergoing a noncurative procedure for relief of symptoms or for management of threatening lesions.
3. Patients have been deemed resectable by the subspecialty surgeon involved in the patient's care
4. Patients must give written informed consent prior to initiation of therapy, in keeping with the policies of the institution. Patients with a history of major psychiatric illness must be judged able to fully understand the investigational nature of the study and the risks associated with the therapy. The only approved consent is attached to this protocol
5. Patients must have ability to comply with study and/or follow-up procedures.
6. Both men and women and members of all races and ethnic groups are eligible for this trial.
Exclusion Criteria:
1. Patients must not have active acute infections that could be worsened by surgery or interfere with this study.
2. Patients must not have clinically significant cardiovascular disease, or peripheral vascular disease that creates an unacceptably high operative risk.
3. Patients must not have history of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates surgical resection, or render the subject at high risk from treatment complications.
4. Patients must not have a history of uncontrolled severe depression.
1. Patients with histologically or cytologically confirmed renal cell carcinoma (RCC).
2. 2. Patients have clinical reasons for undergoing a surgical resection of tumor. There are two main categories of patients: a)Patients with fully resectable disease as defined by lesions accessible by a surgeon during no more than two separate surgical sessions, and are expected to be rendered surgically no evidence of disease (NED). b) Patients undergoing a noncurative procedure for relief of symptoms or for management of threatening lesions.
3. Patients have been deemed resectable by the subspecialty surgeon involved in the patient's care
4. Patients must give written informed consent prior to initiation of therapy, in keeping with the policies of the institution. Patients with a history of major psychiatric illness must be judged able to fully understand the investigational nature of the study and the risks associated with the therapy. The only approved consent is attached to this protocol
5. Patients must have ability to comply with study and/or follow-up procedures.
6. Both men and women and members of all races and ethnic groups are eligible for this trial.
Exclusion Criteria:
1. Patients must not have active acute infections that could be worsened by surgery or interfere with this study.
2. Patients must not have clinically significant cardiovascular disease, or peripheral vascular disease that creates an unacceptably high operative risk.
3. Patients must not have history of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates surgical resection, or render the subject at high risk from treatment complications.
4. Patients must not have a history of uncontrolled severe depression.
Location
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Status: Recruiting
Start Date
June 2009
Sponsors
M.D. Anderson Cancer Center
Source
M.D. Anderson Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page