Status:
ACTIVE_NOT_RECRUITING
Follow-up After Metastasectomy in Patients With Kidney Cancer
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Renal Cell Carcinoma
Eligibility:
All Genders
Phase:
PHASE2
Brief 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 re...
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. T...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 9 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2026
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00918775
Start Date
June 9 2009
End Date
December 20 2026
Last Update
October 14 2025
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030