Radiosurgery in Treating Patients With Kidney Tumors



Status:Active, not recruiting
Conditions:Cancer, Kidney Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/8/2018
Start Date:February 20, 2007
End Date:August 26, 2019

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

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.

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.

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.
We found this trial at
3
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Cleveland, OH
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Orange Village, Ohio 44122
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Orange Village, OH
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Westlake, Ohio 44145
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Westlake, OH
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