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Radiosurgery in Treating Patients With Kidney Tumors

NCT00458484 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2020-07-22

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Mitchell Machtay, MD · University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-20
Primary Completion
2017-03-12
Completion
2019-09-12
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00458484 on ClinicalTrials.gov