NCT00458484

Radiosurgery in Treating Patients With Kidney Tumors

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Kidney Cancer

Interventions

Type	Name	Description
RADIATION	stereotactic radiosurgery	Series I: Radiation will be delivered in 4 fractions. Series II: Radiation will be delivered in 3 fractions.
PROCEDURE	Renal Biopsy	At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.
PROCEDURE	Serum Blood Markers	ELISA blood testing just prior to and immediately following each daily radiation therapy session. Approximately 5cc of blood will be collected within 2 hours prior to and following completion of fractionated radiation therapy to assess the levels of MIF (both MIF-1 and MIF-2) and VEGF.

Timeline

• Start date: 2007-02-20
• Primary completion: 2017-03-12
• Completion: 2019-09-12
• First posted: 2007-04-11
• Last updated: 2020-07-22
• Results posted: 2020-07-22

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study