Follow-up After Metastasectomy in Patients With Kidney Cancer

April 10, 2026 updated by: M.D. Anderson Cancer Center

A Phase II Metastasectomy Study for Patients With Renal Cell Carcinoma

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

86

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Study Population

Patients with renal cell carcinoma that have been deemed resectable

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment

Arms and Interventions

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

What is the study measuring?

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
Time Frame: 24 weeks
Assessed using a logistic regression model.
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS)
Time Frame: Up to 5 years
Up to 5 years
Overall survival (OS)
Time Frame: 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.
Up to 5 years
Disease free survival (DFS)
Time Frame: 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.
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Eric Jonasch, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2009

Primary Completion (Estimated)

December 20, 2026

Study Completion (Estimated)

December 20, 2026

Study Registration Dates

First Submitted

June 10, 2009

First Submitted That Met QC Criteria

June 10, 2009

First Posted (Estimated)

June 11, 2009

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 10, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-0038 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2017-00524 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • R01CA90370 (Other Identifier: National Cancer Institute)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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