Follow-up After Metastasectomy in Patients With Kidney Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Metastasectomy Study for Patients With Renal Cell Carcinoma

Conditions
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Renal Cell Carcinoma

Intervention / Treatment
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* Other: Follow-Up Care
* Other: Laboratory Biomarker Analysis


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational (follow-up)<br>After metastasectomy, patients are followed up every 6 months for up to 5 years. | Other: Follow-Up Care<br>* Undergo follow-up<br>Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binary indicator that the patient is alive with no evidence of disease progression (either progression or relapse) post surgery | Assessed using a logistic regression model. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival (PFS) |  | Up to 5 years | 
| Overall survival (OS) | Will be analyzed by Kaplan Meier plots and appropriate regression analyses using the vector of intervention indicators (ZD, ZE, ZI) as covariates, with the model determined by preliminary goodness-of-fit analyses. | Up to 5 years | 
| Disease free survival (DFS) | Will be analyzed by Kaplan Meier plots and appropriate regression analyses using the vector of intervention indicators (ZD, ZE, ZI) as covariates, with the model determined by preliminary goodness-of-fit analyses. | Up to 5 years |