Radiosurgery in Treating Patients With Kidney Tumors

NCT ID: NCT00458484

Last Updated: 2020-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-20
• Study Completion Date: 2019-09-12

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Series 1: Stereotactic radiosurgery

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.

Group Type: EXPERIMENTAL

stereotactic radiosurgery

Intervention Type: RADIATION

Series I: Radiation will be delivered in 4 fractions.

Series II: Radiation will be delivered in 3 fractions.

Renal Biopsy

Intervention Type: PROCEDURE

At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.

Serum Blood Markers

Intervention Type: PROCEDURE

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.

Series 2: Stereotactic radiosurgery

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.

Group Type: EXPERIMENTAL

stereotactic radiosurgery

Intervention Type: RADIATION

Series I: Radiation will be delivered in 4 fractions.

Series II: Radiation will be delivered in 3 fractions.

Renal Biopsy

Intervention Type: PROCEDURE

At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.

Serum Blood Markers

Intervention Type: PROCEDURE

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.

Interventions

stereotactic radiosurgery

Series I: Radiation will be delivered in 4 fractions.

Series II: Radiation will be delivered in 3 fractions.

Intervention Type: RADIATION

Renal Biopsy

At 6 months,an optional percutaneous renal biopsy will be obtained of the targeted tumor, under ultrasound (US) or CT guidance.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mitchell Machtay, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Locations

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

UH-Chagrin Highlands

Orange, Ohio, United States

UH-Westlake

Westlake, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

P30CA043703

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CASE12806

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2010-01064

Identifier Type: OTHER

Identifier Source: secondary_id

CASE12806

Identifier Type: -

Identifier Source: org_study_id