Follow-up After Metastasectomy in Patients With Kidney Cancer

NCT ID: NCT00918775

Last Updated: 2025-10-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 86 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-09
• Study Completion Date: 2026-12-20

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.

Conditions

Renal Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT

Study Groups

Observational (follow-up)

After metastasectomy, patients are followed up every 6 months for up to 5 years.

Group Type: OTHER

Follow-Up Care

Intervention Type: OTHER

Undergo follow-up

Laboratory Biomarker Analysis

Intervention Type: OTHER

Correlative studies

Interventions

Follow-Up Care

Undergo follow-up

Intervention Type: OTHER

Laboratory Biomarker Analysis

Correlative studies

Intervention Type: OTHER

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric Jonasch

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

M D Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Related Links

http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

NCI-2017-00524

Identifier Type: REGISTRY

Identifier Source: secondary_id

2009-0038

Identifier Type: OTHER

Identifier Source: secondary_id

R01CA90370

Identifier Type: OTHER

Identifier Source: secondary_id

2009-0038

Identifier Type: -

Identifier Source: org_study_id