Follow-up After Metastasectomy in Patients With Kidney Cancer

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: Renal Cell Carcinoma
• Intervention / Treatment: Other: Laboratory Biomarker Analysis; Other: Follow-Up Care

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: Observational
• Enrollment (Actual): 86

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	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

Collaborators and Investigators

• 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

Helpful Links

• University of Texas MD Anderson Cancer Center Website

Study record dates

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): March 28, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Kidney Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Carcinoma, Renal Cell; Carcinoma
• 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