Radiosurgery in Treating Patients With Kidney Tumors
Conditions
Kidney Cancer
Conditions: Keywords
stage I renal cell cancer, stage II renal cell cancer, stage III renal cell cancer, stage IV renal cell cancer
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: stereotactic radiosurgery Type: Radiation
Name: Renal Biopsy Type: Procedure
Name: Serum Blood Markers Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Patient is considered a poor surgical candidate for removal of renal mass as determined by anesthesiology pre-operative assessment or the surgical team, medical team. (No major psychiatric illnesses.)

- Patient is able to give and sign study specific informed consent

- No prior radiation to the treatment field

- Negative serum or urine pregnancy test within 72 hours prior to registration for women of childbearing potential

- Patient has a radiologically and /or pathologically confirmed diagnosis of a renal tumor

- Karnofsky status of >= 60%

- Signed study-specific informed consent prior to study entry

Exclusion Criteria:

- Any patient not meeting the eligibility criteria.

- Any patient with active connective tissue disease such as lupus, dermatomyositis.

- Any patient with active Crohn's disease or active ulcerative colitis.

- Major psychiatric illness, which would prevent completion of treatment or interfere with follow-up.
Locations
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Status: Recruiting
UH-Chagrin Highlands
Orange Village, Ohio, United States
Status: Recruiting
UH-Westlake
Westlake, Ohio, United States
Status: Recruiting
Start Date
February 2007
Sponsors
Case Comprehensive Cancer Center
Source
Case Comprehensive Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page