Radiosurgery in Treating Patients With Kidney Tumors

Kidney Cancer Clinical Trial

Official title: Evaluation of a Radio-Surgical Approach for the Treatment of Kidney Tumors in Poor Surgical Candidates

Status Completed

Clinical Trial Summary

RATIONALE: Radiosurgery can send x-rays directly to the tumor and cause less damage to normal tissue.

PURPOSE: This phase I/II trial studies the side effects and best dose of giving stereotactic radiosurgery and to see how well it works in treating patients with kidney tumors who are poor candidates for surgery.

Clinical Trial Description

OBJECTIVES:

Primary

• To evaluate and compare the clinical safety of utilizing four different schemes of radiosurgical ablative techniques for treating poor surgical candidates with renal tumors.

Secondary

• To evaluate and compare the clinical and radiographic efficacy of four different schemes of radiosurgical ablation of renal tumors in poor surgical candidates.

Serum Blood Marker Objective:

• To determine if serum markers collected before and after radiation may give a predictive indication of tumor response.

OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.

Patients undergo placement of 2-3 fiducial markers in or near the renal tumor. Patients then undergo 4 fractions of stereotactic radiosurgery in the absence of disease progression or unacceptable toxicity. Treatment may repeat at 6 months if tumor is still present.

After radio-surgery, follow-up will be done at 1 , 3 and 6 months and then every 6 months post radiosurgery for a total of 36 months.

PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study. ;

Related Conditions & MeSH terms

• Kidney Cancer
• Kidney Neoplasms

• NCT number: NCT00458484
• Study type: Interventional
• Source: Case Comprehensive Cancer Center
• Status: Completed
• Phase: N/A
• Start date: February 20, 2007
• Completion date: September 12, 2019