Stereotactic Radiation Therapy in Treating Patients With Kidney Tumors

March 16, 2012 updated by: Case Comprehensive Cancer Center

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

RATIONALE: Stereotactic radiation therapy may be able to send x-rays directly to the tumor and cause less damage to normal tissue. Giving stereotactic radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiation therapy in treating patients with kidney tumors.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose of radiation in patients undergoing stereotactic radiotherapy for renal tumors.
  • Determine radiotherapy-associated toxicity in these patients.

Secondary

  • Determine preoperative pathologic response to this regimen in these patients.

OUTLINE: This is a dose-escalation study of radiotherapy.

  • Radiotherapy: Patients undergo stereotactic radiotherapy to 1 tumor. Cohorts of 4-8 patients receive escalating doses of radiotherapy twice daily for 2 days until the maximum tolerated dose (MTD) or upper limit is reached. The MTD is defined as the dose preceding that at which at least 2 of 4 or 3 of 8 patients experience dose-limiting toxicity (DLT). DLT is assessed at 4 and 8 weeks after radiotherapy.
  • Surgery: Two months after completion of radiotherapy, patients undergo preoperative assessment of tumor response followed by partial nephrectomy.

After completion of study therapy, patients are followed periodically for at least 2 years.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106-5065
        • Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Radiologically confirmed renal tumor

    • At least 4 cm in greatest dimension
  • No clinically, radiologically, or pathologically involved lymph nodes
  • No distant metastases

PATIENT CHARACTERISTICS:

  • Karnofsky performance status 70-100%
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Medically eligible for tumor resection
  • No major medical condition or psychiatric illness that would preclude study compliance
  • No active connective tissue disease, such as lupus or dermatomyositis
  • No active Crohn's disease or active ulcerative colitis

PRIOR CONCURRENT THERAPY:

  • No prior chemotherapy
  • No prior abdominal or pelvic radiotherapy
  • No prior cryosurgery
  • No prior radiofrequency ablation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum tolerated dose of radiation
Time Frame: DLT is assessed at 4 and 8 weeks after radiotherapy
DLT is assessed at 4 and 8 weeks after radiotherapy
Radiotherapy-associated toxicity
Time Frame: DLT is assessed at 4 and 8 weeks after radiotherapy
DLT is assessed at 4 and 8 weeks after radiotherapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Disease-free survival
Time Frame: follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery
follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery
Time to local progression
Time Frame: follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery
follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery
Time to distant failure
Time Frame: follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery
follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery
Survival
Time Frame: follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery
follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery
Disease-specific survival
Time Frame: follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery
follow-up will be done at 1 month, 6 12, 18 and 24 months post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Lee E. Ponsky, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

March 7, 2007

First Submitted That Met QC Criteria

March 7, 2007

First Posted (Estimate)

March 9, 2007

Study Record Updates

Last Update Posted (Estimate)

March 20, 2012

Last Update Submitted That Met QC Criteria

March 16, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CASE5806 (Other Identifier: Case Comprehensive Cancer Center)
  • P30CA043703 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Kidney Cancer

Clinical Trials on conventional surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe