Follow-up After Metastasectomy in Patients With Kidney Cancer

Renal Cell Carcinoma Clinical Trial

Official title:

A Phase II Metastasectomy Study for Patients With Renal Cell Carcinoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00918775
• Other study ID #: 2009-0038
• Secondary ID: NCI-2017-0052420
• Status: Active, not recruiting
• Start date: June 9, 2009
• Est. completion date: December 20, 2026

Study information

• Verified date: March 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 86
• Est. completion date: December 20, 2026
• Est. primary completion date: December 20, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Renal Cell Carcinoma

Intervention

Other:
• Follow-Up Care
Undergo follow-up
• Laboratory Biomarker Analysis
Correlative studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Progression free survival (PFS)		Up to 5 years
Secondary	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
Secondary	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

External Links

•   University of Texas MD Anderson Cancer Center Website