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Trial Title:
Follow-up After Metastasectomy in Patients with Kidney Cancer
NCT ID:
NCT00918775
Condition:
Renal Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Renal Cell
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Follow-Up Care
Description:
Undergo follow-up
Arm group label:
Observational (follow-up)
Intervention type:
Other
Intervention name:
Laboratory Biomarker Analysis
Description:
Correlative studies
Arm group label:
Observational (follow-up)
Summary:
This phase II trial studies the follow-up after metastasectomy in patients with kidney
cancer. Following up patients' health condition after metastasectomy may help doctors to
learn if the surgical removal of the 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.
Detailed description:
PRIMARY OBJECTIVES:
I. To assess the 24-week progression free/relapse free survival rate in patients
undergoing metastasectomy for metastatic renal cell carcinoma (mRCC).
SECONDARY OBJECTIVES:
I. To evaluate progression free survival (PFS), relapse free survival (RFS) and overall
survival (OS) in patients undergoing metastasectomy.
II. To evaluate tissue determinants predictive for resectability, PFS and OS in patients
undergoing metastasectomy.
OUTLINE:
After metastasectomy, patients are followed up every 6 months for up to 5 years.
Criteria for eligibility:
Study pop:
Patients with renal cell carcinoma that have been deemed resectable
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Patients with histologically or cytologically confirmed renal cell carcinoma (RCC)
- Patients have clinical reasons for undergoing a surgical resection of tumor; there
are two main categories of patients:
- 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)
- 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
- 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
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
M D Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Start date:
June 9, 2009
Completion date:
December 20, 2026
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00918775
http://www.mdanderson.org