Radiosurgery in Treating Patients With Kidney Tumors

Case Comprehensive Cancer Center (Case CCC)

Status: Completed

Conditions: Kidney Cancer

Treatments: Procedure: Renal Biopsy; Procedure: Serum Blood Markers; Radiation: stereotactic radiosurgery

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00458484

NCI-2010-01064 (Other Identifier)

P30CA043703 (U.S. NIH Grant/Contract)

CASE12806 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Series 1: Stereotactic radiosurgery

Experimental group

Description:

Series I: Radiation will be delivered in 4 fractions. The initial dose level will be 6 Gy per fraction to a total dose of 24 Gy in 4 fractions. Doses will be escalated at 2 Gy per fraction increments to 12 Gy per fraction to a total dose of 48 Gy.

Treatment:

Procedure: Renal Biopsy

Radiation: stereotactic radiosurgery

Procedure: Serum Blood Markers

Series 2: Stereotactic radiosurgery

Experimental group

Description:

Series II: The initial dose level will be 48 Gy to the target volume (tumor) in 3 fractions of 16 Gy per fraction. If acute toxicity is acceptable, then the next four patients will be escalated to 54 Gy in 3 fractions of 18 Gy. Finally if a dose limit has not been reached, the last group of four patients will be treated to 60 Gy in 3 fractions of 20 Gy each.

Treatment:

Procedure: Renal Biopsy

Radiation: stereotactic radiosurgery

Procedure: Serum Blood Markers