Follow-up After Metastasectomy in Patients With Kidney Cancer

NCT00918775 | Active Not Recruiting Phase 2

• 3 other identifiers: 2009-0038NCI-2017-00524R01CA90370
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Progression free survival (PFS)

  Up to 5 years

• Overall survival (OS)

  Up to 5 years

• Disease free survival (DFS)

  Up to 5 years

Study Arms (1)

Observational (follow-up)

OTHER

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

Other: Follow-Up Care; Other: Laboratory Biomarker Analysis

Interventions

Follow-Up Care OTHER

Undergo follow-up

Observational (follow-up)

Laboratory Biomarker Analysis OTHER

Correlative studies

Observational (follow-up)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Aftercare

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Eric Jonasch

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2009
• First Posted: June 11, 2009
• Study Start: June 9, 2009
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)