Follow-up After Metastasectomy in Patients With Kidney Cancer

Active, not recruiting

• Conditions: Renal Cell Carcinoma
• Interventions: Other: Follow-Up Care; Other: Laboratory Biomarker Analysis

• Registration Number: NCT00918775
• Lead Sponsor: M.D. Anderson Cancer Center

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 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.

Study Timeline

• Study Start: 2009-06-09
• Study First Submitted: 2009-06-10
• Study First Submitted QC: 2009-06-10
• Study First Posted: 2009-06-11
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-28
• Primary Completion: 2026-12-20
• Study Completion: 2026-12-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 86

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational (follow-up)	Follow-Up Care	After metastasectomy, patients are followed up every 6 months for up to 5 years.
Observational (follow-up)	Laboratory Biomarker Analysis	After metastasectomy, patients are followed up every 6 months for up to 5 years.

Primary Outcome Measures

Name	Time	Method
Binary indicator that the patient is alive with no evidence of disease progression (either progression or relapse) post surgery	24 weeks	Assessed using a logistic regression model.

Secondary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	Up to 5 years
Disease free survival (DFS)	Up to 5 years	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.
Overall survival (OS)	Up to 5 years	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.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States