Metastasectomy Study in Renal Cell Carcinoma (RCC)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Kidney Cancer |
Other: Evaluation |
| Study Type: | Observational |
| 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 ]
| Estimated Enrollment: | 56 |
| Study Start Date: | June 2009 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Metastasectomy
Kidney cancer patients being considered for surgery
|
Other: Evaluation
Evaluation during and after surgery: vital signs, performance status, physical exam, chest x-ray, CT and MRI plus health questions.
|
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:
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with metastatic renal cell carcinoma (mRCC) and will be undergoing a surgical resection of tumor.
Inclusion Criteria:
- Patients with histologically or cytologically confirmed renal cell carcinoma (RCC).
- 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.
- Patients have been deemed resectable by the subspecialty surgeon involved in the patient's care
- 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
- Patients must have ability to comply with study and/or follow-up procedures.
- Both men and women and members of all races and ethnic groups are eligible for this trial.
Exclusion Criteria:
- Patients must not have active acute infections that could be worsened by surgery or interfere with this study.
- Patients must not have clinically significant cardiovascular disease, or peripheral vascular disease that creates an unacceptably high operative risk.
- 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.
- Patients must not have a history of uncontrolled severe depression.
Contacts and Locations| Contact: Eric Jonasch, MD | 713-792-2830 |
| United States, Texas | |
| UT MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Eric Jonasch, MD | |
| Study Chair: | Eric Jonasch, MD | UT MD Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00918775 History of Changes |
| Other Study ID Numbers: | 2009-0038 |
| Study First Received: | June 10, 2009 |
| Last Updated: | March 18, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
Renal Cell Carcinoma RCC Kidney |
Metastasectomy Surgery Tumor Removal |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Renal Cell Kidney Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Adenocarcinoma Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013